EVIDENCE-BASED CLINICAL GUIDELINES FOR THE MANAGEMENT OF ACUTE LOW BACK PAIN Prepared by Professor Nikolai Bogduk on behalf of THE AUSTRALASIAN FACULTY OF MUSCULOSKELETAL MEDICINE for THE NATIONAL MUSCULOSKELETAL MEDICINE INTIATIVE Submitted for endorsement by the NH&MRC, November 1999 ____________________________________________________________________________________________ i Draft Clinical Practice Guidelines for the Management of Acute Low Back Pain Contents List of Tables ...............................................................................................................................................................iv List of Figures ..............................................................................................................................................................vii Preface .............................................................................................................................................................viii Executive Summary.........................................................................................................................................................ix Chapter 1. Introduction...........................................................................................................................................9 Chapter 2. Definition..............................................................................................................................................6 Chapter 3. Taxonomy.............................................................................................................................................9 Chapter 4. Differential Diagnosis ......................................................................................................................11 Chapter 5. Natural History..................................................................................................................................13 Chapter 6. Prognostic Factors.............................................................................................................................16 Chapter 7. History.................................................................................................................................................24 Chapter 8. Physical Examination.......................................................................................................................39 Chapter 9. Imaging................................................................................................................................................46 Chapter 10. Psychosocial Assessment..................................................................................................................64 Chapter 11. Treatment.............................................................................................................................................68 Chapter 12. Activity versus Bed Rest...................................................................................................................71 Chapter 13. Reassurance and Home Rehabilitation...........................................................................................72 Chapter 14. Exercises..............................................................................................................................................76 Chapter 15. Drug Therapy......................................................................................................................................80 Chapter 16. Manual Therapy..................................................................................................................................85 Chapter 17. Injections..............................................................................................................................................88 Chapter 18. Workplace Intervention.....................................................................................................................90 Chapter 19. Behavioural Therapy..........................................................................................................................92 Chapter 20. Patient Education................................................................................................................................97 Chapter 21. Back School......................................................................................................................................100 Chapter 22. Functional Restoration....................................................................................................................102 Chapter 23. Graded Activity Programs .............................................................................................................105 Chapter 24. Acupuncture.....................................................................................................................................106 Chapter 25. Corsets and Orthoses ......................................................................................................................107 Chapter 26. Traction.............................................................................................................................................108 Chapter 27. Transcutaneous Electrical Nerve Stimulation (TENS)..............................................................109 Chapter 28. Algorithm..........................................................................................................................................110 ____________________________________________________________________________________________ iii Draft Clinical Practice Guidelines for the Management of Acute Low Back Pain List of Tables Table 1.1 Participants in the development process of the present Guidelines Table 4.1. A systematic summary of the possible causes of low back pain in terms of anatomy and pathology. Muscle: refers to any of the muscles of the lumbar spine. Fascia: refers to the thoracicolumbar fascia. Ligament: refers to the interspinous and iliolumbar ligaments. Bone: refers to any part of the lumbar vertebrae or sacrum. Joint: refers to the lumbar zygapophysial joints or the sacroiliac joint. Disc: refers to the intervertebral discs Table 5.1 Outcome of low back pain, 12 months after first consultation, based on Von Korff et al 10. Recent onset was defined as pain commencing within 6 months of first interview Table 6.1 Prognostic risk factors for chronicity of back pain Table 6.2 The fear-avoidance model of back pain. Sites at which behavioural therapy might be applied are marked Y Table 7.1 Categories under which history can be obtained systematically about any pain problem Table 7.2 Distinguishing features between somatic referred pain and radicular pain in the lower limb Table 7.3 Risk factors and indicators for fractures of the lumbar spine. Table 7.4 Statistical data on the validity of clinical features for the diagnosis of cancer of the lumbar spine. SENS: sensitivity. SPEC: Specificity. +LR: positive likelihood ratio. -LR: negative likelihood ratio. Ref: references. SnNout: high sensitivity - negative rules out Table 7.5 Statistical data on the validity of clinical features for the diagnosis of infection of the lumbar spine. SENS: sensitivity. SPEC: Specificity. +LR: positive likelihood ratio. -LR: negative likelihood ratio. Ref: references Table 7.6 Statistical data on the validity of clinical features for the diagnosis of ankylosing spondylitis of the lumbar spine. SENS: sensitivity. SPEC: Specificity. +LR: positive likelihood ratio. -LR: negative likelihood ratio. Ref: references Table 7.7 A checklist for red flag clinical indicators, suitable for inclusion in medical records used in General Practice, developed by the National Musculoskeletal Medicine Initiative Table 7.8 The cardinal Red Flag conditions and the appropriate investigations for their confirmation Table 8.1 The reliability of inspection and palpation in the examination of the lumbar spine. PT: physical therapists. MD: medical practitioners Table 8.2 The reliability of selected tests of motion used in the examination of the lumbar spine. PT: physical therapists. MD: medical practitioners. PPIVM: passive physiological intervertebral motion. PAIVM: passive accessory intervertebral motion Table 8.3 Contingency table for the validity of McKenzie tests in the diagnosis of discogenic pain and painful lumbar disc with a competent anulus. Based on the data of Donelson et al13. Sens: sensitivity. Spec: specificity. LR: likelihood ratio ____________________________________________________________________________________________ iv Draft Clinical Practice Guidelines for the Management of Acute Low Back Pain Table 9.1 Reliability of plain films, based on Coste et al 6 Table 9.2 The prevalence of spondylosis in asymptomatic individuals and patients with lumbar spinal pain, based on Torgerson and Dotter 7. Note that the relationship between spondylosis and symptoms is not significant statistically. N: total number of patients surveyed. n: number affected Table 9.3 The prevalence of disc degeneration in asymptomatic individuals and patients with lumbar spinal pain, based on Torgerson and Dotter 7. Disc degeneration was defined as narrowing of the central portion of the disc by more than 2mm. N: total number of patients surveyed. n: number affected. The relationship between disc degeneration and symptoms is significant (P < 0.05) on a c2 test Table 9.4 Validity of so-called disc degeneration as a diagnostic sign of back pain, based on Torgerson and Dotter 7. Sens: sensitivity. Spec: Specificity. LR: likelihood ratio Table 9.5 The prevalence of spondylolysis in symptomatic and asymptomatic individuals, based on Libson 24 Table 9.6 The prevalence of spondylolysis in sports people Table 9.7 The validity of plain radiography in the diagnosis of painful spondylolysis, based on Libson 24 Table 9.8 Indications for the use of plain films of the lumbar spine, as studied by Deyo and Diehl 5 Table 9.9 Modified criteria for the use of plain films in low back pain Table 9.10 The prevalence of abnormalities on CAT scan in a population 52 asymptomatic individuals aged between 21 and 80 years, based on Wiesel et al 1. The percentage figures are as reported in the study (but rounded to integer values). The numbers have been derived from data provided in the paper, but in some instances are not internally consistent. This arises because not all readers reported on exactly the same number of films. Although the total number of films read by each reader was reported, the total read in each age group was not reported Table 9.11 Observer concordance in the identification and reporting of disc bulges and disc protrusion in MRI scans of 98 asymptomatic individuals based on Jensen et al 2. N: number of subjects examined in each age group. Obs: observer Table 9.12 The prevalence of abnormalities on MRI scans of 67 asymptomatic individuals, as reported by Boden et al 1 Table 9.13 The prevalence of abnormalities on MRI scans of 98 asymptomatic individuals, based on Jensen et al 2. Ranges of percentages obtain because of differences between observers Table 9.14 The prevalence of other abnormalities evident on MRI in asymptomatic individuals, based on Jensen et al 2 Table 9.15 The correlation between back pain and disc protrusion on MRI, based on Jensen et al 1 Table 9.16 Relationship between history and bone scan in patients with a radiographically evident pars defect, based on Lowe et al 4 ____________________________________________________________________________________________ v Draft Clinical Practice Guidelines for the Management of Acute Low Back Pain Table 9.17. Correlations between bone scan and X-ray in 33 athletes with suspected spondylolysis, based on Elliot et al 5 Table 9.18 Correlations between bone scan and X-ray in 37 athletes with back pain, based on Jackson 6,7 Table 9.19 Correlations between bone scan and X-ray in 66 patients with back pain, based on Van den Oever 8 Table 10.1 A list of the cardinal yellow flags Table 11.1 Rating scale for quality of evidence recommended by the NH&MRC in 1995 1 Table 11.2. Rating scale for quality of evidence recommended by the NH&MRC in 1999 2 ____________________________________________________________________________________________ vi Draft Clinical Practice Guidelines for the Management of Acute Low Back Pain List of Figures Figure 6.1 A model of prognostic risk factors. The objectives of research are to detect the risk factors for the development of chronicity of back pain. The factors may be biological or psychosocial, and immutable or remediable. Research may focus on detecting psychosocial or biological factors or both Figure 13.1 Survival curves comparing the proportion of patients still on sick leave after treatment by activation or under usual care. Based on Indahl et al 2 Figure 28.1 An algorithm for the management of acute low back pain. ª National Musculoskeletal Medicine Initiative ____________________________________________________________________________________________ vii Draft Clinical Practice Guidelines for the Management of Acute Low Back Pain Preface *TO BE COMPLETED ____________________________________________________________________________________________ viii Draft Clinical Practice Guidelines for the Management of Acute Low Back Pain Executive Summary *TO BE COMPLETED Chapter 1. Introduction In order to introduce the following Guidelines for the Evidence-Based Management of Acute Low Back Pain, this chapter addresses several seminal issues: why the need for guidelines, how they were prepared, by whom, and what they entail. Why Back pain is a common health problem in Australia. Data from the Australian Bureau of Statistics 1 indicate that, in 1989-1990, 607,800 individuals presented with back pain as a recent illness. This incidence was exceeded only by that of headache, arthritis, asthma, the common cold and dermatitis. As a cause of long- term illness, back disorders affected 1,921,400 individuals: more than the number affected by hay fever, asthma, hypertension, and dermatitis, as the leading causes of long-term illness; and exceeded only by the number of people who wore glasses. In 1995 2, back problems were experienced as a recent illness by 635,700 people, exceeded again only by the number of people with headache, arthritis, hypertension, asthma and the common cold. By way of reference, other health problems were experienced by fewer than 561,500 people. Back problems accounted for 895,200 people with chronic illness, exceeded only by disorders of refraction, arthritis, hay fever, asthma, hypertension, sinusitis, deafness, allergy and varicose veins. Other, individual major medical problems affected fewer than 495,100 people. That a condition is common is not reason alone to justify the production of guidelines for management. Guidelines are not required if the condition is already adequately managed. There are no explicit data on how well back pain is managed in Australia. Those with concerns, such as insurers and workers compensation authorities, and even the Department of Health and Community Services, usually do not publish data and their views. The Grellman report 3 from the WorkCover Authority of NSW reported concerns about the growing cost of workers' compensation in New South Wales, and back problems were a major component of burden of illness covered by this report. Local concerns seem to be driven, or echo, international concerns. Perceiving that there is, indeed, a problem in the way that back pain is managed, several countries have prepared guidelines in recent years. The leading reports are the AHCPR guidelines 4, the UK guidelines 5, and the Dutch guidelines 6. Those of New Zealand 7, are a reproduction of the UK guidelines 5. Based on the experience of its members, the Australasian Faculty of Musculoskeletal Medicine, and its founding associations: the Australian Association of Musculoskeletal Medicine and the New Zealand Association of Musculoskeletal Medicine, believed that back pain was, indeed, poorly managed, both in Australia and in New Zealand. Accordingly, the Faculty believed that guidelines were required. Moreover, because it believed that overseas guidelines were inappropriate, inadequate, incomplete or out-of-date, the Faculty felt that an Australian product was justified. Even if it were to prove not true, that back pain was poorly managed in Australia, the Faculty felt that there was nevertheless merit in harvesting and providing for Australian medical practitioners and other interested parties a synopsis of what would constitute evidence-based, best practice for this condition. How The Guidelines for Acute Low Back Pain were prepared under the auspices of the National Musculoskeletal Medicine Initiative: a program developed by the Australasian Faculty of Musculoskeletal ____________________________________________________________________________________________ ix Draft Clinical Practice Guidelines for the Management of Acute Low Back Pain Medicine at the invitation of the Federal Minister for Health - Dr Michael Wooldridge. The Initiative was commissioned: 1. to develop the evidence-base for medical management of acute musculoskeletal pain problems; 2. to evaluate the efficacy, safety, and cost-effectiveness of evidence-based care for these problems; and 3. to determine by audit how these problems are currently managed in general practice. Back pain is but one of the musculoskeletal problems addressed by the Initiative. Others include, neck pain, shoulder pain, pain in the elbow, pain in the wrist, thoracic spinal pain, hip pain, knee pain, and pain in the ankle and foot. The guidelines for the management of acute low back pain were the first to be produced, and are the first to be submitted for public review. In preparing the Guidelines for Acute Low Back Pain, the Faculty, for the greater part, followed the guidelines for guidelines issued by the NH&MRC, first the first edition 8, and subsequently the second edition 9 of those guidelines. The cardinal exception is that the Guidelines were not prepared by a multidisciplinary panel (see below). In accordance with the rating scale of Ward and Grieco 10, the present guidelines • address acute low back pain; • suffered by adults (they expressly avoid the issue of back pain in children); • define proposed interventions; • have reduced pain and disability, and improved safety and cost-effectiveness as health outcomes; • used an extensive literature search to identify evidence; • provide evidence synthesised into prose-form, according to NH&MRC guidelines; • provide references to all information gathered; • were subjected to review; • identify exceptions where known and where appropriate; • are unambiguous to those who have read them to date; • use clear headings, lists and flow charts; • list the participants who participated in their development. Certain of the criteria of Ward and Grieco 10 were not fulfilled. • Costing associated with the proposed interventions have not been produced. These are being determined in the National Musculoskeletal Medicine Initiative, and will be available late in 2000. • A date of publication has been deferred until the NH&MRC has assessed the Guidelines. • No review date is specified because there is no guarantee that the Faculty of Musculoskeletal Medicine will have the resources in the future to continue to update the Guidelines. In accordance with the Guiding Principles of the NH&MRC 8 : • The development and evaluation process of the present Guidelines was focused on the outcomes of safety, efficacy, and cost-effectiveness, with respect to pain and disability. • The Guidelines were based on the best available evidence. • Wherever possible, the evidence was synthesised on the basis of published systematic reviews where available, and an assessment of every available randomised controlled trial. Indeed, the literature is sometimes so meagre, that both approaches were used. • When offered, statements or recommendations are accompanied by a statement of strength of evidence in terms of the Guidelines of the NH&MRC 9. • As described below, the process of guideline development was novel, but involved multi- disciplinary review and consumers. ____________________________________________________________________________________________ 2 Draft Clinical Practice Guidelines for the Management of Acute Low Back Pain • The Guidelines are sufficiently flexible as to be adaptable to varying local conditions. • Ironically, the implementation of the Guidelines requires no new resources, provided that practitioners are informed of them and abide by them. The cost of developing the Guidelines was borne by individual members of the Australasian Faculty of Musculoskeletal Medicine, with the technical support of staff of the National Musculoskeletal Medicine Initiative. • The Guidelines have been in use for three years under the auspices of the National Musculoskeletal Medicine Initiative, in which their safety, efficacy and cost-effectiveness is being assessed by audit. but • There is no guarantee that the Guidelines will be updated regularly, for the Australian Faculty of Musculoskeletal Medicine does not have the resources to maintain the academic and technical staff require to maintain the Guidelines, and the National musculoskeletal Medicine Initiative shall terminate in July 2000. Comparison with Other Guidelines By definition, the present Guidelines are more up-to-date than previous guidelines 4,5, for they are based on literature published since those previous guidelines were prepared. The present Guidelines are only slightly more up-to-date than the Dutch Guidelines 6. The present Guidelines are dissonant in certain respects from those of the AHCPR 4 and the UK 5. This arises because those latter guidelines accepted consensus views in their recommendations, whereas the present Guidelines are explicitly evidence-based, in accordance with the second edition of the NH&MRC Guidelines for Guidelines which no longer recognises consensus or expert opinion as a form of evidence. In this regard, the present Guidelines are more in keeping with the Dutch Guidelines 6. Compared with those of the NASS 11 and the AAOS12, the present guidelines explicitly and exclusively address back pain, and do not address sciatica and disc herniation, which was the focus of these American guidelines. Where the present Guidelines depart considerably from other and previous guidelines is that they address topics not entertained by other guidelines, such as history and examination, which are critical components of the assessment of patients with back pain. These topics were not addressed in an evidence-based manner by other guidelines. Whereas other guidelines focussed on the efficacy of treatments, the present guidelines have gathered the evidence-base for the reliability and validity of history, physical examination and investigations. Conflict of Interest Transparently and unashamedly, the present Guidelines have been developed with the medical practitioner in mind, particularly primary care practitioners, on the grounds that it is medical practitioners who have a comprehensive responsibility in the management of their patients. It is they who are ultimately responsible for the assessment and investigation of patients, prior to treatment; and it is they, who have the legal privilege and responsibility concerning the use of specific investigations for specific conditions, when the need for these arises. With respect to treatment, comparisons between craft groups and different health professions are avoided as far as possible unless these are mentioned in the literature cited and are pertinent to the evaluation of evidence. Instead, treatments are evaluated in a generic sense, without specification of who did, who can, or who should, provide those treatments. It is the efficacy of the treatment, not the effectiveness of a craft group that is emphasised in these Guidelines. ____________________________________________________________________________________________ 3 Draft Clinical Practice Guidelines for the Management of Acute Low Back Pain