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Corresponding author. Department of Orthopaedic and Spinal Surgery AMEC (Aizu Medical Center) at Fukushima Medical University, 21-2 Maeda, Tanisawa, Kawahigashi, Aizu-wakamatsu, Fukushima, 969-3492, Japan. Fax: +81 242 75 2568.
The latest clinical guidelines are mandatory for physicians to follow when practicing evidence-based medicine in the treatment of low back pain. Those guidelines should target not only Japanese board-certified orthopaedic surgeons, but also primary physicians, and they should be prepared based entirely on evidence-based medicine. The Japanese Orthopaedic Association Low Back Pain guideline committee decided to update the guideline and launched the formulation committee. The purpose of this study was to describe the formulation we implemented for the revision of the guideline with the latest data of evidence-based medicine.
Methods
The Japanese Orthopaedic Association Low Back Pain guideline formulation committee revised the previous guideline based on a method for preparing clinical guidelines in Japan proposed by Medical Information Network Distribution Service Handbook for Clinical Practice Guideline Development 2014. Two key phrases, “body of evidence” and “benefit and harm balance” were focused on in the revised version. Background and clinical questions were determined, followed by literature search related to each question. Appropriate articles were selected from all the searched literature. Structured abstracts were prepared, and then meta-analyses were performed. The strength of both the body of evidence and the recommendation was decided by the committee members.
Results
Nine background and nine clinical qvuestions were determined. For each clinical question, outcomes from the literature were collected and meta-analysis was performed. Answers and explanations were described for each clinical question, and the strength of the recommendation was decided. For background questions, the recommendations were described based on previous literature.
Conclusions
The 2019 clinical practice guideline for the management of low back pain was completed according to the latest evidence-based medicine. We strongly hope that this guideline serves as a benchmark for all physicians, as well as patients, in the management of low back pain.
1. Introduction
The latest clinical guidelines are mandatory for physicians to follow when practicing evidence-based medicine in the treatment of low back pain. Those guidelines should target not only Japanese board-certified orthopaedic surgeons, but also primary physicians, and they should be prepared based entirely on evidence-based medicine. The Japanese Orthopaedic Association (JOA) guideline for the management of low back pain (LBP) was first published in 2012 [
]. Since then, they have received plenty of attention from many healthcare professionals who manage patients with LBP. However, many new articles have since been published, following the release of the first edition, containing new information on the basic and clinical issues of LBP. Thus, the JOA LBP guideline committee decided to update the guideline and launched the formulation committee. The purpose of this study was to describe the formulation we implemented for the revision of the guideline with the latest data of evidence-based medicine.
The rationale of the 2019 edition is as follows: 1) the targets of the guideline are not only Japanese board-certified orthopaedic surgeons, but also other clinicians, such as primary care physicians; 2) the guideline should be designed to help clinicians managing LBP patients in daily practice; 3) the main purposes of the guideline are triage and primary care for LBP patients; 4) the guideline should meet the current standards of LBP management in Japan; 5) the guideline is intended for all patients with acute, subacute, and chronic LBP; 6) the guideline is intended for LBP patients both with and without lower limb symptoms; and 7) the term “non-specific LBP” should be utilized carefully in the guideline, because its definition has yet to be fully elucidated.
Since the rationale of the 2019 edition was the same as that of the 2012 edition, most of the clinical questions (CQs) in the 2012 edition were used in the 2019 edition. However, clinical and epidemiologic characteristics such as definition, pathophysiology, natural course, examination and diagnosis were added as background questions (BQs) without systematic literature searches or systematic review. The questions about treatment and prevention were added as CQs with meta-analysis and systematic review. In the results, a total of nine BQs and nine CQs were included in the 2019 edition.
2. Guideline formulation methods
Editorial tasks for the update were performed in accordance with the Medical Information Network Distribution Service (MINDS) Handbook for Clinical Practice Guideline Development 2014 (MINDS 2014) [
]. MINDS 2014 proposes preferred methods of guideline preparation in Japan, based on the following global standards for developing clinical guidelines: The Grading of Recommendations Assessment, Development and Evaluation (GRADE) system; Cochrane Collaboration; Agency for Healthcare Research and Quality (AHRQ); and the Oxford Evidence-Based Medicine Center. In MINDS 2014, the preparation procedures of guidelines are defined precisely, and the importance of a viable body of evidence is specifically emphasized. For CQs, study reports are collected via a systematic method, and are evaluated by outcome data and study design. The results are evaluated in light of a viable body of evidence, and are required to emphasize the balance between risk and benefit.
The 2019 LBP guideline formulation committee members for the revised 2019 edition consisted of 13 experienced orthopaedic spine surgeons (one chairperson and 12 members), selected from the councilors of the Japanese Society of Lumbar Spine Disorders (JSLSD) and entrusted directly by the JOA. The editorial process was supported by two advisers (one who specializes in anesthesiology and pain management, and the other who is a senior orthopaedic surgeon), and one technical adviser who is a gastroenterological surgeon as well as a guideline formulating specialist of MINDS. No systematic review team was set up; alternatively, a structured abstract preparation team, which is mentioned later, was set up, and that team members and the 13 committee members performed the review process.
3. Results of the literature search
In the preparation for the revised 2019 edition, we performed a MEDLINE search of the literature that included articles published from April 1, 2008 through March 31, 2016. This search utilized the search formula presented in Table 1 and extracted 4942 articles. The articles in Japanese published through the same period were also searched using ICHU–SHI, which was published by the NPO Japan Medical Abstracts Society. The similar formula was utilized to extract 1275 Japanese articles.
Table 1Search formula utilized on MEDLINE between April 1, 2008 and March 31, 2016.
Medline
No.
Search formula
L1
S back pain + NT/CT
L2
S (BACkache? or backpain? or lumbago?)/TI or (back or lumber? or vertebrogenic (1A) (pain? or ache?)/TI or failed (1W) back (1W) surgery (1W) syndrome?/TI
L3
S L1 OR L2
L4
S L3 and 2008–2016/PY and 20080401–20160331/up not EPUB?/FS
L5
S L4/human or (L4 not animals + NT/CT)
L6
S L5 and (EN or JA)/LA
L7
S L6 not (case report?/DT or case? (W) (report? or series?) or expert? (W) opinion?)
For primary selection of the articles, the following criteria were set: 1) exclusion criteria; the articles without abstract, meeting proceedings, communication, and the title without the mention of low back pain; and 2) inclusion criteria; randomized controlled trial (RCT, regardless of subject numbers), observational study (100 subjects or more), case series study (500 subjects or more), systematic review, and meta-analysis. A primary selection resulted in 2686 of the total 6217 articles. Then, a secondary selection was performed for the following topics; 1) definition of LBP; any type of article was accepted, because of the limited number of primarily selected articles; 2) epidemiology and pathophysiology; articles that included 500 subjects or more; 3) diagnosis, treatment, and prevention; all systematic review, meta-analysis, and RCT with 50 subjects or more, the other types of article with 100 subjects or more; 4) treatment and prevention; only RCTs were selected if there were more than one RCT for each CQ; and; 5) treatment; the Cochrane Database of Systematic Reviews (CDSR) was selected without any conditions as it had the strongest evidence. The secondary selection resulted in 755 articles, among which 318 were selected after discussing the suitability. We also picked up another 58 articles by hand-search. Finally, a total of 376 articles were selected as a final decision for the guidelines.
4. Preparation of structured abstracts and evaluation of the articles
We asked 72 Japanese spine experts to prepare structured abstracts of the 376 articles together with the formulation committee members. The committee members in charge of each BQ and CQ evaluated the content of the articles based on the abstracts, and then performed meta-analysis.
5. Strength of evidence and recommendations
The selected 376 articles were evaluated by outcome data, bias risks, lack of direction, inconsistencies, inadequacies, publication bias, and others to formulate a viable body of evidence. The strength of the body of evidence was determined according to Table 2. Answers and explanations for each CQ were described, and the strength of the recommendation was decided using a GRADE grid, as described in Table 3 and by referring to the balance between risk and benefit. A final decision was made when at least 70% of the committee members were in agreement. When received less than 70% of the votes, further discussion was conducted, followed by a second vote. Answers and explanations were considered to be understandable enough for all primary physicians, because LBP patients visit any physicians except orthopaedic surgeons.
Table 2Strength of evidence.
□ A
(High)
High confidence in the estimated treatment effect
□ B
(Moderate)
Moderate confidence in the estimated treatment effect
□ C
(Low)
Limited confidence in the estimated treatment effect
The committee asked for public comments on a draft of the guidelines from the following societies in the field of orthopaedic surgery; JOA, JSLSD, Japanese Society for Spine Surgery and Related Research (JSSRS), and Japanese Association for the Study of Musculoskeletal Pain (JAMP). A total of 187 comments were submitted and reviewed. As a result, the final draft was completed.
7. JOA 2019 clinical practice guideline for the management of LBP
7.1 Definition of LBP
7.1.1 BQ1. What is the definition of LBP?
LBP can be defined as the following;
•
Pain area; Pain in the area on the posterior aspect of the body, from the lower margin of the 12th ribs to the lower gluteal folds, with or without pain in one or both lower limbs that lasts for at least one day.
•
LBP duration; Acute LBP (less than 4 weeks), subacute LBP (over 4 weeks and less than 3 months), and chronic LBP (more than 3 months).
LBP is one of the most common reasons for people to visit clinics in Japan, as well as in the USA and European countries. LBP causes an enormous economic burden on individuals, families, communities, industry and government. However, its definition remains unclear. The reason may be that LBP is not a disease, but a symptom. There are many etiologic diseases behind LBP. Therefore, it is necessary to define LBP according to several perspectives (Table 4).
Table 4Classification based on the causes of LBP.
1)
Spinal column and its adjacent musculoskeletal organs
Spinal tumors (primary or metastatic), infection (pyogenic spondylodiscitis, tuberculous spondylitis), trauma (vertebral fracture), herniated nucleus pulposus, degenerative lumbar canal stenosis, isthmic spondylolisthesis, degenerative spondylolisthesis, osteoporosis, osteopenia, spinal deformity (scoliosis, kyphosis, kyphoscoliosis), inflammatory arthritis (ankylosing spondylitis, psoriatic spondylitis), ossification of ligaments, musculofascial, discogenic, or facet joint pain syndrome, pain in the sacro-iliac joint or hip joint.
2)
Nervous system
Tumors originating from the spinal cord or cauda equina
3)
Visceral organs
Reno-urinary diseases (kidney or urinary calculus, pyelonephritis), gynecological diseases (endometriosis), and pregnancy
First, the painful area is important when defining LBP. Because pain in the buttocks is sometimes a radicular symptom, it should be paid careful attention when making a diagnosis. Lower limb symptoms, such as pain and numbness, often accompany LBP [
Second, LBP can be defined based on the duration from the onset. Acute LBP is usually defined as having less than 4 weeks’ duration, whereas the definition of chronic LBP is more than 3 months [
]. There is no established consensus on the definition of subacute LBP. Therefore, for our purposes, subacute LBP was defined as LBP with a duration of longer than 4 weeks but less than 3 months.
Third, LBP is raised by many anatomical tissues that compose the spinal column. These include intervertebral discs, facet joints, nerve roots, periosteum, muscles, fascia, ligaments, vessels, and others. Various diseases and traumas involving the tissues described above can be a source of LBP.
7.2 Pathophysiology, epidemiology, and natural course
7.2.1 BQ2. What is the pathology of low back pain?
•
LBP has various kinds of pathologies, which occur from the lumbar spine up to the brain.
•
Non-specific LBP is a syndrome that has unestablished and undiscovered pain mechanisms.
•
Future studies of intervertebral disc degeneration, genomic- and epigenomic analyses, and imaging studies of brain function by developing technology will reveal new pathologies of LBP.
The causes of LBP are traditionally categorized into spinal, neural, visceral, vascular, psychological, and others (Table 4 of BQ1). The causes of LBP are divided into two groups. One group is a series of disorders; for example, spinal tumors, intervertebral disc herniation, and ureteral stone, for which there are established diagnoses/definitions, and often treatments.
The second group is disorders/syndromes that have no established diagnoses/definitions/treatments, such as muscular/fascial LBP, discogenic LBP, and psychogenic LBP. They have often been called “non-specific LBP”, but some have been transferred to the first group, when their pathology/diagnosis was elucidated.
The Clinical Practice Guideline for the Management of Low Back Pain 2012 (1st edition) [
] In that study, they reported that “up to 85% of patients cannot be given a definitive diagnosis because of weak associations among symptoms, pathological changes, and imaging results”. This quote demonstrates that definitive diagnosis of LBP, as well as treatment choice, is not easy to make, and this message partially succeeded to educate LBP patients who never stop trying to find the root cause of their LBP. However, a recent Japanese study [
] by orthopaedic surgeons reported that, in the clinical setting, ‘specific LBP’ was diagnosed in 250 (78%) patients and non-diagnosable, ‘non-specific LBP’ was present in 70 (22%) patients. Although one paper is not enough to prove the validity of this finding, it indicates that the 85% non-specific LBP mentioned in the 2012 guideline warrants further investigation.
In elucidating the pathologies of LBP hereafter, we need to study not only local lumbar spine and surrounding tissues, but also the brain by evolving technologies. In the lumbar spine, biomechanics of the intervertebral disc, vertebral bone, and paraspinal muscles are now the target of research. Regarding pain analysis, nociceptors and the somatosensory nervous system including the posterior horn of the spinal cord and dorsal root ganglion are being investigated. With regard to the brain, functional analysis of pain is under rapid development.
7.2.1.1 Disc degeneration and LBP
Two systematic reviews/meta-analyses reported the relationship between abnormal image findings in the lumbar spine and pain; one study using radiography and the other using magnetic resonance imaging (MRI).
], is a meta-analysis of 28 studies, and it reported a strong relationship between intervertebral disc narrowing judged by radiography and LBP among 26,107 LBP patients aged over 18 years: Odds ratio (OR) 1.47, Confidence interval (CI) 13.6–1.58 from a local population; and OR 1.76, CI 1.34–2.33 from occupational studies. Spondylosis and bone spurs had moderate relationships with LBP, whereas endplate sclerosis and disc injury had no significant relationships.
MRI findings of disc degeneration are more prevalent in adults with low back pain than in asymptomatic controls: a systematic review and meta-analysis.
] performed a meta-analysis of 14 studies, and compared 1193 LBP patients over 50 years with 1094 non-LBP patients using MRI imaging. The factors that had non-significant relationships with LBP were central stenosis, high-intensity zone, and endplate fissure. The factors that had significant relationships with LBP were disc bulging (OR 7.54; 95%CI 1.28–44.56), spondylolysis (OR 5.06; 95%CI 1.65–15.53), disc prolapse (OR 4.38; 95%CI 1.98–9.68), Modic type 1 change (OR 4.01; 95%CI 1.10–14.55), disc protrusion (OR 7.54; 95%CI 1.28–44.56), and disc degeneration (OR 2.24; 95%CI 1.21–4.15).
While nerve fibers are not present in the normal disc, we can detect them in degenerated discs. These fibers are believed to deliver pain signals, including neuropathic pain, which has been found in 16.7–54.4% of chronic LBP patients, according to one systematic review [
7.2.1.2 Biomechanics of the lumbar spine, pelvis, and LBP
To detect the dysfunction of the lumbar spine and pelvis as parts of a weight-bearing system, kinematic analysis has been performed using sensors such as surface markers. One systematic review [
] of 43 papers reported the relationship between lumbo-pelvic kinematics and pain: no difference in lumbar lordosis, decreased range of motion of the lumbar spine, no difference in proportions of the lumbar spine and pelvis, and pelvic tilt in the standing position between patients with pain and control. In LBP patients, there was a lag of motion and a decrease in proprioception. The authors acknowledged in their limitations that there was no proof of a cause–effect relationship.
7.2.1.3 Genetic analysis
Genetic analysis is useful not only to reveal the risk factors of LBP, but also to elucidate its pathogenesis. In one systematic review [
] of 10 articles, heritability was found to be 0–67%, and the contribution rate increased in LBP patients with disabilities or in chronic LBP patients. One study from England [
] analyzed 2256 female twins, and found ORs of LBP were 6 in mono-zygotic twins and 2.2 in dizygotic twins.
7.2.1.4 Brain image analysis
The brain, an organ which receives and interprets pain signals from every body part, is related to prolonged intractable pain. Brain studies performed in LBP patients include measurements of grey and white matter volume, blood oxygen level-dependent (BOLD) MRI, and positron emission tomography (PET) reflects metabolism of glucose and amino acids as brain functional analysis.
] analyzed brain MRI by voxel-based morphometry in 543 chronic LBP patients, and found decreased prefrontal and anterior insular gray matter. Moreover, a systematic review [
] analyzed 27 papers which dealt with chronic LBP by brain MRI, and found regional changes in gray and white matter, with an altered functional connectivity during rest and increased activity in pain-related areas following painful stimulation, evidencing an upregulated pain matrix.
7.2.1.5 Fibromyalgia and chronic wide-spread pain and LBP
In several pain disorders, pain spreads to multiple areas of the body. Mental symptoms often manifest as physical problems: somatoform disorders. In one cross-sectional study [
], 25.2% of 647 chronic LBP patients satisfied the criteria for wide-spread pain syndrome, and pain was severe and persistent in female patients, those with coexisting mental symptoms assessed by the psychological status inventory, and those with multiple comorbidities assessed by the comorbidity questionnaire.
7.2.2 BQ3. What is the clinical course of low back pain?
•
The clinical course of acute LBP is generally good and, in most cases, it resolves spontaneously. The clinical course of chronic LBP is poorer than that of acute LBP. Psychosocial factors may prolong back pain. A physically and mentally healthy lifestyle contributes to a good prognosis for LBP.
Although LBP is a highly prevalent condition, its clinical course has not been fully elucidated due to inconsistencies in the types of LBP and the variety of interventions reported in previous studies. To date there have been two systematic reviews summarizing cohort studies on the clinical course of LBP.
A systematic review of 33 prospective cohort studies [
] (a total of 11,166 patients with LBP) observing the clinical course of pain and disability, showed that the mean pain score (out of a maximum score of 100) for cohorts with acute LBP was 52 at baseline, which markedly improved to 23 at 6 weeks after the onset of pain, followed by a slower improvement to 12 at 26 weeks then to 6 at 52 weeks. Among the patients with chronic LBP, the mean pain score was 51 at baseline, which significantly improved to 33 at 6 weeks after the onset of pain, but the subsequent pain improvement was poorer compared that in the acute LBP patients; the pain score was 26 at 26 weeks then 23 at 52 weeks. The course of disability outcomes was similar to the time course of pain outcomes in the patients with acute LBP, but the pain outcomes were slightly worse than the disability outcomes in the patients with chronic LBP.
In a systematic review of 11 prospective cohort studies [
] that followed the clinical course of non-specific LBP for more than 1 year, 33% of patients had improved symptoms in the first 3 months, but 65% still had LBP after 1 year. From these findings, the assumption that spontaneous recovery occurs in a large majority of patients is not justified in cases of non-specific LBP.
] investigating pain and functional outcomes of patients with non-specific LBP who visited an emergency department (ED), 48% of patients reported functional impairment, 42% reported moderate or severe pain, and 46% reported analgesic use at 3 months after ED discharge. From these results, it was suggested that patients with severe back pain and dysfunction who visit an ED are more likely to have prolonged symptoms.
As a special case, there is a study that followed the clinical course of LBP in children for 4 years [
]. A longitudinal study of 2025 randomly selected children aged 9–14 years from the German resident registry showed that the prevalence of LBP increased as the participants grew, and girls had a higher prevalence and recurrence of LBP than boys. In a study of 639 women who developed LBP during pregnancy [
], LBP remained in 176 cases at 6 months postpartum. At 1 year after delivery, 34 (19.3%) of the 176 patients who had LBP at 6 months had no pain, 115 (65.3%) had recurrent LBP, and 27 (15.3%) had chronic LBP. The patients with chronic LBP had a higher extent of sick leave and healthcare-seeking behavior compared to women with recurrent LBP.
There have been various studies, most of which were observational, on the factors associated with LBP prolongation. Two of those studies were systemic reviews investigating the involvement of psychosocial factors. In a systematic review of 4683 cases from 10 studies that investigated the relationship between expectations about recovery and return to work [
], the odds that patients with acute or subacute non-specific LBP will remain absent from work due to progression to chronic LBP are two times greater for those with negative recovery expectations than for those with more positive expectations. A systematic review of 19 studies that investigated the relationship between clinical course of LBP and catastrophizing thoughts [
] also showed that catastrophizing thoughts are associated with delayed recovery of LBP, dysfunction, and return to work.
Factors associated with the improvement of LBP include exercise habits, younger age, good health, few comorbidities, and no psychological/physical dysfunction [
Self-reported moderate-to-vigorous leisure time physical activity predicts less pain and disability over 12 months in chronic and persistent low back pain.
]. In women, a healthy lifestyle including no smoking, low alcohol intake, leisure exercise, high fruit and vegetable intake has been shown to be favorable for LBP prognosis [
Does a healthy lifestyle behaviour influence the prognosis of low back pain among men and women in a general population? A population-based cohort study.
]. In a cohort study of university students, it was reported that the habit of using lumbar support devices while using a computer may prevent the onset and persistence of LBP [
Risk factors for persistency and recurrence of LBP include history of LBP, aging, obesity, smoking, depression, cognitive dysfunction, onset after a traffic accident, height (women over 170 cm tall), and low education level [
Expectation of recovery from low back pain: a longitudinal cohort study investigating patient characteristics related to expectations and the association between expectations and 3-month outcome.
Stability of low back pain reporting over 8 years in a general population aged 40/41 years at base-line: data from three consecutive cross-sectional surveys.
]. Furthermore, in a study conducted in Japanese patients, it was reported that the risk factors for chronicity of LBP were heavy physical labor, low workability, and many physical complaints [
There are few studies with a high level of evidence, such as randomized controlled trials, regarding the relationship between weight control, smoking, drinking, or daily exercise and low back pain.
•
Regarding body weight, a weak correlation with the risk of developing low back pain was observed in both underweight and overweight cohorts compared to a healthy (BMI: 18.5 to 25.0) weight range, suggesting weight management is preferable for preventing low back pain.
•
It has been pointed out that smoking and drinking are associated with the risk of developing back pain and its prevalence.
•
The risk of low back pain is higher in groups that do not exercise normally compared to in groups that exercises routinely.
•
For the prevention of low back pain, relaxation and stress-free lifestyles are recommended.
] revealed a weak association (OR: 1.17, 95% CI 1.12–1.13) between LBP and low body weight (BMI <18.5) compared to standard weight (BMI of 18.5–25.0). In addition, an increased risk of low back pain was observed in the overweight to obese (BMI >25) category compared to the standard weight category (Fig. 1). Furthermore, the comparison between obese (BMI >30) and non-obese (BMI ≤30) participants regarding the association with LBP prevalence showed a weak association in the obese group. A meta-analysis [
] of 33 studies that were adjusted for publication biases revealed a relationship between obesity and LBP, i.e. being overweight or obese were modifiable risk factors for LBP. These findings suggest that maintaining a normal body weight is associated with the prevention of LBP [
Six studies reporting on the association between smoking status (non-smokers, smokers, past smokers, and days smoked per week) and LBP prevalence were identified. A meta-review on LBP prevalence among smokers and non-smokers revealed a OR of smokers compared to non-smokers of 0.79 (95%CI 0.74–0.83), favoring smokers (Fig. 2) [
]. Comparison of LBP prevalence among non-smokers and past-smokers (not current smokers) revealed no clear association favoring either cohort. On the contrary, Shiri et al.'s meta-analysis found a higher prevalence and incidence of LBP in both smokers and past-smokers than in non-smokers; a trend that was more pronounced in younger people [
Prevalence and influencing factors of chronic back pain among staff at special schools with multiple and severely handicapped children in Germany: results of a cross-sectional study.
Alcohol intake has been suggested to have an association with LBP. In our meta-analysis of two studies, a comparison of drinkers and non-drinkers revealed that regular alcohol consumption is associated with a lower prevalence of LBP [
]. (Fig. 3) However, a meta-analysis by Ferreira et al. found an association between alcohol intake and prevalence of LBP (OR 1.3 [95%CI 1.1–1.5]). It is important to note that the number of studies reported to date is limited, and the number of subjects is small, so caution should be exercised when interpreting the observations [
In a limited number of studies that have investigated the effects of exercise on the prevalence of LBP, a weak association was shown favoring regular exercise (exercise of at least 3 days/week) compared to rarely exercise (1 day/week or less; Fig. 4) [
]. A study comparing a non-exercise group with an exercise group (30 min exercise in last week at least once) showed an increased risk of LBP in the non-exercise group [
]. These observations should, however, be considered with caution due to the limited number and low quality of studies included in our meta-review. We identified a total of one RCT of yoga, 19 RCTs of exercise, and nine RCTs of multidisciplinary rehabilitation, for pain and functional improvement in LBP patients. Overall, exercise was associated with the prevention and improvement of LBP with weak evidence favoring the recommendation of an active daily life incorporating moderate exercise for the prevention of chronic LBP [
Three high-quality RCTs showed effectiveness of mindfulness-based stress reduction methods in LBP patients. Additionally, three randomized studies that examined the progressive muscle relaxation method showed an association with lower prevalence of LBP. A stress-reduced or stress-free lifestyle is recommended for the prevention of LBP [
Pharmacological and toxicological profile of opioid-treated, chronic low back pain patients entering a mindfulness intervention randomized controlled trial.
7.3.1 BQ5. Is occupation related to low back pain?
•
Heavy labor with a physical load is a risk factor for low back pain (LBP). However, there is only moderate evidence for a relationship between occupation and LBP.
•
Job conditions and psychosocial factors associated with work sites are related to onset and prognosis of LBP.
There are many case reports showing an association of occupation-specific lumbar load with onset of LBP. Epidemiological studies of the relationship between LBP and occupation in Japan have found the following incidences by occupation: 71–74% in transport, 69% in cleaning, 46–65% in nursing, and 63% in caring [
]. These results suggest that heavy labor with a physical load is a risk factor for LBP. A systematic review of LBP and occupational physical activities showed a correlation of work involving heavy objects and lifting with LBP, and a strong correlation of lumbar flexion, rotation and forward movement with LBP [
]. Eight longitudinal meta-analyses of LBP and work involving lifting of heavy objects have found that the frequency of lifting is significantly related to rate of onset of LBP [
]; therefore, there is no evidence for this relationship at present. Occupation-based physical activities are suspected to be a cause of LBP, but the quality of most previous studies is insufficient, and it is also difficult to assess LBP and find a causal relationship due to the absence of clear evidence [
]. Therefore, the evidence linking LBP and occupation is considered to be moderate.
Psychosocial factors at a work site that influence LBP include satisfaction level, work humdrum, human relations, heavy workload, mental stress and self-assessment of job performance, and these are strongly associated with future onset of LBP [
]. Poor psychosocial prognostic factors for LBP are low satisfaction level, depression, low sociability and phobic avoidance (catastrophic thinking of further deterioration with no reason) [
]. We reviewed these factors using the Cochrane Database of Systematic Reviews, including 6 systematic reviews and 84 randomized controlled trials (RCTs). About half of the RCTs examined prognostic factors for LBP. Information on general health, social support, and work-related conditions was rarely reported, and further prospective RCTs are needed [
Incomplete reporting of baseline characteristics in clinical trials: an analysis of randomized controlled trials and systematic reviews involving patients with chronic low back pain.
]. A systematic review of patients who had developed low back pain within the previous 3 months found that in addition to age and leg pain, poor prognostic factors for low back pain included previous low back pain, depression, work problems, and job dissatisfaction [
]. However, another systematic review of factors affecting return to work of low back pain patients found that depression, job satisfaction, and mental stress were not prognostic factors [
In the primary care field, one systematic review analyzed psychosocial factors associated with the transition from acute low back pain to chronic nonspecific low back pain in the three domains of social and socio-occupational, psychological, and cognitive and behavioral factors. It noted the presence of compensation issues, depression, psychological distress, passive coping strategies, and fear avoidance beliefs as independent risk factors. However, it did not find that occupation, educational level, social status, job satisfaction, or socio-occupational factors had any effect on the prognosis of low back pain [
A systematic review of the influence of catastrophizing (see Background question 3) on treatment for nonspecific low back pain found that catastrophizing affected the severity and persistence of low back pain, disability, and the effect of treatment [
A systematic review of the role of fear avoidance beliefs (excessive limitation of physical activity out of anxiety or fear of pain) as a prognostic factor for poor outcome in patients with nonspecific low back pain found that fear avoidance beliefs increased the risk of not returning to work and sick days in patients with subacute low back pain (4 weeks–3 months after onset) and were a prognostic factor for poor outcome. Early therapeutic intervention to reduce fear avoidance beliefs may thus avoid delayed recovery and chronicity of low back pain. However, fear avoidance beliefs cannot be described as an outcome-determining prognostic factor for ultra-acute low back pain (within 2 weeks of onset) or chronic low back pain (≥3 months after onset) [
A systematic review of prospective cohort studies of psychological predictive factors for the transition to chronicity of acute or subacute low back pain found that distress, depression, and somatization contribute to the transformation to chronic low back pain [
Psychosocial factors encompass a wide range of factors, ranging from social factors such as job, educational level, social status, and compensation issues to depression and other psychological factors, in addition to cognitive and behavioral factors comprising characteristic patterns of thinking such as catastrophizing about pain and fear avoidance beliefs as well as passive coping, and these factors may both be independent and interact with each other. Different factors are also influential at different stages from acute low back pain to chronic low back pain. It must also be noted that the effects of psychosocial factors differ depending on outcomes, including the severity of low back pain, low back pain-induced disability, quality of life (QOL), activities of daily living (ADL), rate of return to work, and time to return to work.
7.4 Diagnosis
7.4.1 BQ7. How a diagnostic procedure should be on a patient's first visit?
In the first consultation of a patient with LBP, careful neurological examination with detailed history-taking is essential to avoid accidental misdiagnosis [
]. The concept of red flags related to severity, progress, malignancy, and chronicity of a disease is important when identifying serious diseases. Red flags are; an age of less than 20 or more than 55 years old; continuous severe LBP; chest pain; cancer; steroid use; human immunodeficiency virus infection; body weight loss; multiple neurological deficits; severe structural deformity; fever; and others [
]. The identification of the red flags differs depending on the guidelines, but spinal fractures, infections, and tumors are the most important red-flag diseases because they can result in fatal paraplegia and/or death [
X-ray, CT, MRI, and blood examination are important measurements for differentiating LBP. In particular, X-ray and blood examinations are thought to be first line tools because they involve commonly-used, low-cost equipment. They also help to exclude red-flag diseases from non-specific LBP. Early application of radiographic examination for LBP is not recommended in many guidelines because high quality systematic reviews have revealed no difference in 1-year outcomes between early and late examination groups [
]. CT scan is able to detect compression fractures that go unseen in usual X-rays, and MRI is indispensable for the diagnosis of cancer, disc herniation, fractures, and infections [
]. In general, diagnostic rates will increase if more supplementary examinations are used, but correct diagnosis at a low-cost and minimum radiation exposure is important for physicians [
7.4.2 BQ8. Which radiological modalities help to diagnose LBP?
•
Plain X-ray has potential significance in the initial diagnosis of LBP. However, initial routine imaging in patients with non-specific LBP without neurological symptoms is not always necessary.
•
For patients with red flags or neurological symptoms, MRI is recommended, following plain X-ray. MRI is useful for evaluating and scrutinizing spinal components such as intervertebral discs, vertebral endplates, and paraspinal muscles.
•
Discography and facet arthrography may be useful in the diagnosis of LBP, but a combination of multiple imaging modalities should be employed for more accurate diagnosis.
Imaging studies in the diagnosis of LBP are the gold standard because they provide a more multifaceted, non-invasive evaluation of the triaged red flags observed in the interview and physical examination, to ensure a higher rate of correct diagnoses. In a case series, only 20 of 11,825 patients with LBP could not be initially diagnosed even after additional imaging examinations were performed (plain X-ray, computed tomography (CT) scan, and Magnetic resonance imaging (MRI)) following physical examination, and 14 patient of the 20 patients were diagnosed as having red flags after further investigation, including tissue biopsy [
]. Thus, current imaging modalities are essential diagnostic tools, and the combination of multiple modalities, especially CT and MRI, is significantly important in the diagnosis of LBP.
7.4.2.1 Plain X-ray
Plain X-ray is the most widely used imaging modality for diagnosing LBP, because it is low cost and highly convenient. In an analysis of the process by primary care physicians involved in the care of 145,430 patients with LBP, accurate diagnosis was made in 53.9% of patients using some imaging examinations including plain X-ray within four weeks of the initial visit [
]. These findings should also be considered when performing imaging examinations in patients with possible red flags. Therefore, based on the clinical practice, imaging examinations including plain X-ray is recommended for the detailed initial diagnosis of LBP, although not in all cases.
Although it is difficult to assess LBP-related tissue degeneration in detail using a plain X-ray only, it has been reported that degeneration of the disc space, osteophytes, and sclerosis are all associated with non-specific LBP. However, the odds ratio is low, ranging from 1.2 to 3.3, and the evidence for an association between X-ray findings and non-specific LBP is insufficient [
]. An analytical cross-sectional study showed that narrowing of the intervertebral disc space was more strongly associated with LBP than other findings [
]. According to a report on the usefulness of plain X-ray for patients with LBP lasting more than 6 weeks, there are no direct associations between radiography and functional prognosis or improvement with regard to pain severity or health status [
] that can cause LBP. In a cross-sectional study of patients with spinal arthritis, 10% of the patients had vertebral fractures, which is advantageous for morphological evaluation of the condition, even if it is not the result of a trauma [
The prevalence of vertebral fractures in spondyloarthritis: relation to disease characteristics, bone mineral density, syndesmophytes and history of back pain and trauma.
]. Furthermore, having one vertebral fracture increases the risk of developing a new vertebral fracture, which may be associated with chronic back pain and dysfunction [
Based on the above, we believe that plain X-ray examination itself is useful for diagnosing and evaluating the causes of LBP. However, plain X-ray is not necessarily indicated in cases of non-specific LBP.
7.4.2.2 MRI, CT scan
MRI and CT scan have higher sensitivity than plain X-ray in the diagnosis of patients suspected of having red flags or neurological symptoms. In particular, recent studies indicate that MRI is more reliable than CT scan: Most of the support for this is related to the analysis of pathological conditions brought about by advances in MRI technology. A meta-analysis showed its usefulness in that disc bulging, disc degeneration, Modic type I endplate changes, and lumbar spine slippage were significantly correlated with LBP in patients under 50 years of age [
MRI findings of disc degeneration are more prevalent in adults with low back pain than in asymptomatic controls: a systematic review and meta-analysis.
On the other hand, a cohort study in which a 12-month follow-up MRI was performed for all LBP patients showed that improvement in their symptoms was only observed in 53% of the patients [
]. Because MRI can detect disc degeneration and other degenerative findings in asymptomatic patients, it is controversial as to whether it should be regarded as a viable option in the early phase of the primary care setting.
Determining when MRI should be performed is also controversial. Randomized control trials reported that switching from plain lumbar X-rays to MRI for primary care patients does not necessarily result in additional benefits, but it does result in increased treatment costs [
]. On the other hand, performing MRI at an early stage has been reported to lead to shorter treatment times, fewer referrals to specialists, and lower total medical costs than MRI scanning on demand [
Routine versus needs-based MRI in patients with prolonged low back pain: a comparison of duration of treatment, number of clinical contacts and referrals to surgery.
]. Some studies have also suggested that early testing is associated with a small improvement in symptoms, although it does not affect the overall treatment [
A number of studies have found possible primary causes of LBP using MRI. One systematic review reported an association of MRI findings with possible causes of LBP such as disc protrusion, nerve root deviation and/or compression, and disc degeneration. However, these possible causes have also been reported in a high percentage of asymptomatic patients [
Potential of magnetic resonance imaging findings to refine case definition for mechanical low back pain in epidemiological studies: a systematic review.
]. In other words, these conditions alone indicate physiological changes with age. Several studies have reported that the frequency of disc degeneration increased with age and was associated with lower back pain [
Recent improvements in the function of MRI have led to several reports on the effects of Modic changes, which are vertebral endplate changes, on non-specific LBP. Imaging analysis showed a stronger correlation between endplate degeneration and LBP in the lower lumbar vertebrae than in the upper lumbar vertebrae [
Modic changes of the lumbar spine: prevalence, risk factors, and association with disc degeneration and low back pain in a large-scale population-based cohort.
], while it has been reported that Modic change type I was not a risk factor for the development of LBP in 148 asymptomatic patients followed for 3 years [
]. In an analytical cross-sectional study of 975 residents' examinations, the correlation between LBP and Modic changes was found in patients with a combination of LBP and Modic changes [
The association of combination of disc degeneration, end plate signal change, and Schmorl node with low back pain in a large population study: the Wakayama Spine Study.
]. Modic changes were also correlated with LBP in men and in patients with a high BMI, which may hinder the rate of returning to work because of the lack of improvement in pain and function [
Type 1 Modic changes was a significant risk factor for 1-year outcome in sick-listed low back pain patients: a nested cohort study using magnetic resonance imaging of the lumbar spine.
Furthermore, quantitative analyses of lumbar anatomy using MRI showed that adipose tissue in lumbar spine multifidus muscles increased paraspinal muscle atrophy, and that fatty infiltration can correlate with low back and leg pain [
The relationship of lumbar multifidus muscle morphology to previous, current, and future low back pain: a 9-year population-based prospective cohort study.
7.4.2.3 Single photon emission computed tomography (SPECT)
To date, there are no reports with enough evidence that have studied the clinical efficacy of SPECT for LBP. One review article reported SPECT to be useful in the detection of pseudarthrosis after spinal fusion surgery, in the evaluation of back pain in infants, adolescents and young adults, and in the differentiation of benign and malignant lesions in cancer patients [
Discography and intradiscal injections are particularly useful in the diagnosis and treatment of intervertebral disc pain. Fluoroscopic discography is an invasive procedure, and its diagnostic significance has decreased in recent years with the development of imaging modalities such as MRI. On the other hand, a meta-analysis of the usefulness of discography showed that its specificity in patients with discogenic LBP was as high as 0.92, and the false positive rate was as low as 6%, suggesting the usefulness of the discography in exploring the pathology of discogenic pain [
]. Furthermore, RCTs have reported that pain relief by from intradiscal injection of small amounts of bupivacaine may be useful in diagnosing discogenic LBP in addition to reproducing LBP using discography [
]. On the other hand, it has been suggested that discography is not always a reliable indicator in patients with chronic LBP, because intradiscal injections in asymptomatic patients can induce pain, and the pain response may be amplified in patients with psychological factors [
]. Although this needs to be fully considered, it does not entirely negate the usefulness of discography, given that not all disc degeneration findings on MRI necessarily correlate with LBP.
b.
Facet arthrography and related injection
Regarding the involvement of the facet joints in LBP, a series of studies have shown that the reproducibility of diagnostic blocks of the facet joints is low, with a specificity of 62%. In comparison, the rate of suspicious positive results is reported to be as high as 38%, suggesting that facet joint injections themselves are not fully reliable [
]. On the other hand, in a single-arm study with 152 cases of facet nerve block, 89.5% of the patients showed improvement in their back pain even after two years postinjection [
Making sense of the accuracy of diagnostic lumbar facet joint nerve blocks: an assessment of the implications of 50% relief, 80% relief, single block, or controlled diagnostic blocks.
]. Some reports conclude that there is moderate evidence for the efficacy of facet joint and nerve block injections for LBP in the short and long term [
Association between clinical signs assessed by manual segmental examination and findings of the lumbar facet joints on magnetic resonance scans in subjects with and without current low back pain: a prospective, single-blind study.
], indicating the usefulness of multidimensional evaluation using multiple radiological modalities.
c.
Nerve root block
Although nerve root blocks are mainly used for LBP associated with nerve root symptoms, their diagnostic value for non-specific LBP is controversial. There is moderate evidence in the diagnosis of pathological level determination [
EMG is one of the tests that can be used to evaluate skeletal muscle dysfunction, and there are multiple reports on its interpretation. Surface EMG is a useful test for evaluating patients with multiple intervertebral disorders such as lumbar spinal stenosis [
]. In a report describing the results of surface EMG analysis in 41 patients with chronic LBP, normalized peak EMG was higher, and muscle strength was significantly lower in the chronic LBP group compared with a control group consisting of those with no history of LBP [
]. EMG is also one of the most established electrophysiological tests for evaluating nerve root disorders, and can identify the presence of pathological lesions. In summary, EMG may be a useful tool in assessing back muscle dysfunction, as well as the effects of rehabilitation in patients with LBP, but it is difficult to recommend as a critical diagnostic test for non-specific LBP.
7.5 Treatment
7.5.1 CQ.1 Is advice to stay active more effective than advice to rest in bed for people with LBP?
•
For patients with acute lower back pain, advice to continue normal activity is more effective than advice to rest in bed.
•
For patients with sciatica, there is little or no difference between advice to continue normal activity and advice to rest in bed.
(Recommendation level 2, Agreement rate 88.9%, Strength of evidence C).
Two systematic reviews of RCTs of bed rest for LBP have been reported since April 2008. A systematic review of RCTs published up to 2009 [
] cited in the first edition of this guideline. The updated review included trials with both male and female participants, between 16 and 80 years of age, who had acute (up to six week-duration) LBP or exacerbations of chronic pain lasting less than six weeks. And the review included trials with 2 categories of LBP:
1)
Acute simple LBP (i.e. LBP without neurological deficits)
2)
Sciatica (i.e. LBP with verified neurological deficits)
As a result, advice to stay active is more effective than advice to rest in bed for improving pain with low quality evidence and for functional status with moderate quality evidence. We performed a meta-analysis based on the Cochrane review (Fig. 6) [
]. The results showed low quality evidence for pain intensity and moderate quality evidence for functional status. And there is low quality evidence that advice to stay active has more effect on the length of sick leave than advice to rest in bed. In contrast, for patients with sciatica, there is moderate quality evidence of little or no difference in pain relief or functional status, between advice to rest in bed or stay active (Fig. 7) [
], does not include RCTs published after 2010, but there are differences in the selected RCTs. There is low-quality evidence that bed rest is ineffective on pain in the immediate (≤2 weeks after randomization), short (>2 weeks, <3 months), and intermediate terms (≥3 months, <12 months), with results favoring normal activity. The effects of bed rest on functional status match those for pain similarly showing no significant effect of bed rest in the same period with low quality evidence. There is low quality evidence that advice to stay active has little or no better effect on the length of sick leave than advice to rest in bed in the short term, although the former has more effect than the latter in the immediate term.
A clinical practice guideline from the American College of Physicians (ACP) published in 2017 [
] recommend that clinicians should advise patients with acute, subacute, or chronic LBP to remain active as tolerated. However, evidence on patient-important outcomes, such as disability or return to work, is largely unavailable, and available evidence shows no clear connection with improvements in pain.
7.5.2 CQ.2 Is pharmacotherapy useful for low back pain?
•
Pharmacotherapy is useful for pain relief and functional improvement. (Recommendation 1. Strength of evidence B)
For clinical question 2, we conducted a systematic review of nine drugs using only RCTs comparing to placebo. It should be noted that RCTs comparing two drugs and observational studies were not included in this systematic review, so it does not cover all the evidence for each drug. In the evaluation of the literature, the nine drugs were examined for each of acute LBP, chronic LBP, and LBP with sciatica. A meta-analysis was conducted when there were multiple RCTs using the same evaluation method. Finally, we reviewed 45 RCTs [
Treatment of chronic low back pain with etoricoxib, a new cyclo-oxygenase-2 selective inhibitor: improvement in pain and disability--a randomized, placebo-controlled, 3-month trial.
Efficacy and safety of lornoxicam compared with placebo and diclofenac in acute sciatica/lumbo-sciatica: an analysis from a randomised, double-blind, multicentre, parallel-group study.
Aceclofenac-tizanidine in the treatment of acute low back pain: a double-blind, double-dummy, randomized, multicentric, comparative study against aceclofenac alone.
Evaluation of eperisone hydrochloride in the treatment of acute musculoskeletal spasm associated with low back pain: a randomized, double-blind, placebo-controlled trial.
Analgesic efficacy and safety of tramadol/acetaminophen combination tablets (Ultracet) in treatment of chronic low back pain: a multicenter, outpatient, randomized, double blind, placebo controlled trial.
Ultracet ER Study Group A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of the extended-release tramadol hydrochloride/acetaminophen fixed-dose combination tablet for the treatment of chronic low back pain.
Efficacy and safety of flupirtine modified release for the management of moderate to severe chronic low back pain: results of SUPREME, a prospective randomized, double-blind, placebo- and active- controlled parallel-group phase IV study.
Tramadol/acetaminophen combination tablets for the treatment of chronic lower back pain: a multicenter, randomized, double-blind, placebo-controlled outpatient study.
Efficacy and safety of the seven-day buprenorphine transdermal system in opioid-naïve patients with moderate to severe chronic low back pain: an enriched, randomized, double-blind, placebo-controlled study.
Analgesic tolerance without demonstrable opioid-induced hyperalgesia: a double-blinded, randomized, placebo-controlled trial of sustained-release morphine for treatment of chronic nonradicular low-back pain.
Efficacy and safety of tapentadol extended release for the management of chronic low back pain: results of a prospective, randomized, double-blind, placebo- and active-controlled Phase III study.
A 12-week, randomized, placebo-controlled trial assessing the safety and efficacy of oxymorphone extended release for opioid-naive patients with chronic low back pain.
Effect of minocycline on lumbar radicular neuropathic pain: a randomized, placebo-controlled, double-blind clinical trial with amitriptyline as a comparator.
]. Among them, 27 (60%) had a conflict of interest (COI) involving a pharmaceutical company and did not report negative results on the analgesic effect. The meta-analysis also included papers before the concept of COI was established. Therefore, it should be recognized that COI could affect the majority of research results.
Voting was used by the attending committee to determine which drugs to be recommended for LBP, and those that had more than 70% of votes were selected as recommended drugs. A recommendation level for each recommended drug was also determined by voting of members. The level was selected when more than 70% of them agreed. Fig. 8 shows a list of recommended drugs.
7.5.3 CQ.3 Are physical and orthotic therapies useful for the treatment of low back pain?
Some of the physical and orthotic therapies for the treatment of low back pain are suggested to be useful. However, there are only a few high-quality studies; thus, recommendations are made with caution.
•
Traction (Recommendation 2, Agreement ratio 90%, Strength of evidence C)
•
Ultrasound (Recommendation 2, Agreement ratio 80.0%, Strength of evidence C)
•
Transcutaneous electrical nerve stimulation (Recommendation 2, Agreement ratio 70.0%, Strength of evidence C)
•
Hyperthermia therapy (Recommendation 2, Agreement ratio 100.0%, Strength of evidence C)
•
Lumbar support (Recommendation 2, Agreement ratio 80.0%, Strength of evidence C)
Cochrane reviews and hand searches were performed to investigate the improvement of pain and functional scores, and the cost of each treatment for acute, subacute or chronic low back pain. Searches were made for traction, ultrasound, transcutaneous electrical nerve stimulation (TENS), and hyperthermia/cold treatment among physical therapies and lumbar support and insoles as orthotic treatment. Meta-analyses were performed where possible.
7.5.3.1 Traction
Traction therapy is a treatment method for patients with low back pain (usually also presenting with sciatica), in which the upper half of the body is fixed to a surface such as a bed, and is pulled by a harness wrapped around the pelvis to extend the lumbar spine. It is assumed that the applied stress reduces the load on the intervertebral discs and the pressure on the sciatic nerves.
Traction therapy in sciatica due to disc prolapse (does traction treatment have any positive effect on patients suffering from sciatica caused by disc prolapse?).
Is there a subgroup of patients with low back pain likely to benefit from mechanical traction? Results of a randomized clinical trial and subgrouping analysis.
] were included. In addition, one study that evaluated the effect of traction therapy compared to sham-traction in patients with low back pain without sciatica was identified [
No effect of traction in patients with low back pain: a single centre, single blind, randomized controlled trial of Intervertebral Differential Dynamics Therapy.
A study comparing the effects of traction or sham traction on patients with low back pain accompanied by sciatica, and assessing the alleviation of lower limb pain or low back pain [
], showed no significant difference in the frequency of complete recovery during the 3-week treatment period. However, a significant difference (p < 0.01) between the rate of patients who recovered completely and those who recovered partially was recorded. No significant difference in outcomes was observed in a study [
Traction therapy in sciatica due to disc prolapse (does traction treatment have any positive effect on patients suffering from sciatica caused by disc prolapse?).
Is there a subgroup of patients with low back pain likely to benefit from mechanical traction? Results of a randomized clinical trial and subgrouping analysis.
]. Studies that evaluated traction treatment in combination with a wide range of physiotherapy interventions, including treatment with hot packs, ultrasound, and electrical stimulation, have reported a slight improvement in pain scores with traction, but many were not significantly different in the overall assessment [
No effect of traction in patients with low back pain: a single centre, single blind, randomized controlled trial of Intervertebral Differential Dynamics Therapy.
], the VAS evaluation seen in both groups at 14 weeks showed improvement relative to before the initiation of the treatment, but no difference was observed between the two groups. A study [
] examining whether the addition of traction therapy to physical therapy was beneficial showed only low-quality evidence that traction could slightly improve the outcome.
Currently, the reported studies do not provide sufficient evidence to recommend traction therapy for patients with low back pain (including sciatica). Although some low-quality studies have reported pain improvement and shortened time to functional recovery, these findings have not been confirmed by high quality RCTs. Treatment with traction has not been shown to improve symptoms compared to placebo or sham treatment.
7.5.3.2 Ultrasound
Ultrasound therapy involves stimulation of the subcutaneous tissue with high-frequency ultrasound, and is a commonly applied treatment for musculoskeletal diseases. Ultrasound is either given in a continuous or pulsed manner, and is said to have beneficial effects by transmitting sound wave energy to the target tissue, thereby increasing tissue temperature or promoting other physiological changes.
A total of four studies were included in the Cochrane review, which compared the effects of ultrasound therapy on low back pain with sham ultrasound therapies or placebo controls [
Effects of therapeutic ultrasound and electrical stimulation program on pain, trunk muscle strength, disability, walking performance, quality of life, and depression in patients with low back pain: a randomized-controlled trial.
Effects of therapeutic ultrasound and electrical stimulation program on pain, trunk muscle strength, disability, walking performance, quality of life, and depression in patients with low back pain: a randomized-controlled trial.
Effects of therapeutic ultrasound and electrical stimulation program on pain, trunk muscle strength, disability, walking performance, quality of life, and depression in patients with low back pain: a randomized-controlled trial.
]. To evaluate the efficacy, VAS pain assessment was used. The comparisons, including a total of 121 patients, 60 in the ultrasound treatment group and 61 in the sham-treated cohort [
Effects of therapeutic ultrasound and electrical stimulation program on pain, trunk muscle strength, disability, walking performance, quality of life, and depression in patients with low back pain: a randomized-controlled trial.
], showed no significant difference in VAS assessment (mean difference −7.12, 95% CI -17.99, 3.75) (Fig. 10). Recovery of function was also evaluated and compared in 100 patients; 50 patients who received ultrasound therapy and 50 patients who received sham treatment, but no significant difference was reported (mean difference −3.95, 95% CI -8.33, 0.42) [
Effects of therapeutic ultrasound and electrical stimulation program on pain, trunk muscle strength, disability, walking performance, quality of life, and depression in patients with low back pain: a randomized-controlled trial.
]. In an additional study, 41% of patients with low back pain associated with lumbar disc herniation and sciatica improved with ultrasound therapy and showed more effective than sham-ultrasound therapy (12% improved) or analgesic drugs (6.8% improved) [
]. Another small RCT of low back pain in 36 patients did not show a significant reduction in pain intensity in the ultrasound therapy group compared to the sham-treated group at a one-month follow-up [
The current evidence is insufficient to recommend ultrasound therapy for the treatment of low back pain. In addition, meta-analysis data suggest a low level of evidence that ultrasound treatment does not improve VAS or functional scores, compared to placebo or sham control treatments. Higher quality RCTs should be undertaken to establish conclusive evidence regarding the effects of ultrasound therapy on low back pain.
TENS is a common treatment option that stimulates subcutaneous peripheral nerves with continuous electrical stimulation. Neural stimulation is relatively inexpensive and is provided by a wearable unit that is mobile and can be used at home. Electrical stimulation is supplied by electrodes attached to the skin which can generate electrical pulses at different frequencies, amplitudes, pulse widths, and waveforms, with generally high intensity at low frequencies (<10Hz) or low intensity at high frequencies (>80Hz). It is hypothesized that the pain-relieving effects can be obtained through the excitation of sensory nerves, artificially inducing the pain and/or opioid systems. Transducing the sensation of pain via nerve stimulation.
We identified two RCTs in our analysis that evaluated the effect of TENS on low back pain compared to sham treatment [
]. In a low-quality study, the evaluation of VAS pain score during TENS significantly decreased 60 min after TENS (63.11 ± 31.2), while no significant change in the VAS score was observed in the sham treatment group (95.8 ± 14.1) [
]. In one high-quality study, VAS and functional scores, as well as range of motion in patients with low back pain were evaluated after TENS and those were compared to a placebo control during a 4-week follow-up. As a result, no significant difference was reported between the two groups [
Does a healthy lifestyle behaviour influence the prognosis of low back pain among men and women in a general population? A population-based cohort study.
Transcutaneous electrical nerve stimulation [TENS] for short-term treatment of low back pain–randomized double blind crossover study of sham versus conventional TENS.
] examined changes in disability after TENS and reported an average difference of −1.36 (95% CI -4.38, 1.66). Low-quality evidence that TENS treatment does not significantly improve pain and disability compared with sham treatment has been reported [
There is insufficient evidence to recommend TENS for the treatment of low back pain from previously reported studies. The potential benefits of TENS in the treatment of low back pain appear to be limited, but large, high-quality RCTs are needed to confirm any potential beneficial effects.
7.5.3.4 Hyperthermia therapy and cryotherapy
Hyperthermia therapy or cryotherapy is an inexpensive treatment that is commonly applied to patients with low back pain, mainly in the acute and subacute phases. However, no studies have explored the use of superficial cryotherapy as a treatment for low back pain. A Cochrane review [
] identified a total of four studies exploring the effects of surface heat in the form of applying heating wraps or blankets for the treatment of patients with acute or subacute low back pain [
]. No studies have yet evaluated surface hyperthermia in patients with chronic low back pain. Heat application was compared to either unheated wraps or oral placebo tablets as a control. The included studies were limited as they only assessed short-term effects. In two of these studies, a total of 243 participants treated with heat wrapping were found to have a significant reduction in short-term pain scores (range 0–5) compared to a placebo cohort receiving tablets at 4–5 days post-treatment [
]. Both studies reported a significant reduction in short-term unpleasantness scores (range 1–100) with a weighted mean difference of 13.50 (95%CI -21.27, −5.73) with local warming with heat wrapping (Fig. 11). The two studies also reported a significant improvement in short-term functional improvement score (0–24) 4–5 days after heat wrapping treatment compared to placebo. A study compared the effect of heating for acute symptomatic low back pain relief during emergency transport [
] between a passive wool blanket and an “active” electric heating blanket and showed an immediate and significant reduction of pain scores with the electric heating blanket [
]. Finally, as an adverse effect of hyperthermia, redness of the skin was reported in 1 of 120 patients in the placebo group and 6 of 123 in the heat-treated group [
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