Alexander Y.P. Chan

Individualised physiotherapy as an adjunct to guideline-based advice for low back disorders in primary care: a randomised controlled trial

Background Many patients with low-back disorders persisting beyond 6 weeks do not recover. This study investigates whether individualised physiotherapy plus guideline-based advice results in superior outcomes to advice alone in participants with low-back disorders. Methods This prospective parallel group multicentre randomised controlled trial was set in 16 primary care physiotherapy practices in Melbourne, Australia. Random assignment resulted in 156 participants receiving 10 sessions of physiotherapy that was individualised based on pathoanatomical, psychosocial and neurophysiological barriers to recovery combined with guideline-based advice, and 144 participants receiving 2 sessions of physiotherapist-delivered advice alone. Primary outcomes were activity limitation (Oswestry Disability Index) and numerical rating scales for back and leg pain at 5, 10, 26 and 52 weeks postbaseline. Analyses were by intention-to-treat using linear mixed models. Results Between-group differences showed significant effects favouring individualised physiotherapy for back and leg pain at 10 weeks (back: 1.3, 95% CI 0.8 to 1.8; leg: 1.1, 95% CI 0.5 to 1.7) and 26 weeks (back: 0.9, 95% CI 0.4 to 1.4; leg: 1.0, 95% CI 0.4 to 1.6). Oswestry favoured individualised physiotherapy at 10 weeks (4.7; 95% CI 2.0 to 7.5), 26 weeks (5.4; 95% CI 2.6 to 8.2) and 52 weeks (4.3; 95% CI 1.4 to 7.1). Responder analysis at 52 weeks showed participants receiving individualised physiotherapy were more likely to improve by a clinically important amount of 50% from baseline for Oswestry (relative risk (RR=1.3) 1.5; 95% CI 1.2 to 1.8) and back pain (RR 1.3; 95% CI 1.2 to 1.8) than participants receiving advice alone. Conclusions 10 sessions of individualised physiotherapy was more effective than 2 sessions of advice alone in participants with low-back disorders of ≥6 weeks and ≤6 months duration. Between-group changes were sustained at 12 months for activity limitation and 6 months for back and leg pain and were likely to be clinically significant. Clinical trial registration ACTRN12609000834257.

Specific treatment of problems of the spine (STOPS): design of a randomised controlled trial comparing specific physiotherapy versus advice for people with subacute low back disorders

BackgroundLow back disorders are a common and costly cause of pain and activity limitation in adults. Few treatment options have demonstrated clinically meaningful benefits apart from advice which is recommended in all international guidelines. Clinical heterogeneity of participants in clinical trials is hypothesised as reducing the likelihood of demonstrating treatment effects, and sampling of more homogenous subgroups is recommended. We propose five subgroups that allow the delivery of specific physiotherapy treatment targeting the pathoanatomical, neurophysiological and psychosocial components of low back disorders. The aim of this article is to describe the methodology of a randomised controlled trial comparing specific physiotherapy treatment to advice for people classified into five subacute low back disorder subgroups.Methods/DesignA multi-centre parallel group randomised controlled trial is proposed. A minimum of 250 participants with subacute (6 weeks to 6 months) low back pain and/or referred leg pain will be classified into one of five subgroups and then randomly allocated to receive either physiotherapy advice (2 sessions over 10 weeks) or specific physiotherapy treatment (10 sessions over 10 weeks) tailored according to the subgroup of the participant. Outcomes will be assessed at 5 weeks, 10 weeks, 6 months and 12 months following randomisation. Primary outcomes will be activity limitation measured with a modified Oswestry Disability Index as well as leg and back pain intensity measured on separate 0-10 Numerical Rating Scales. Secondary outcomes will include a 7-point global rating of change scale, satisfaction with physiotherapy treatment, satisfaction with treatment results, the Sciatica Frequency and Bothersomeness Scale, quality of life (EuroQol-5D), interference with work, and psychosocial risk factors (Orebro Musculoskeletal Pain Questionnaire). Adverse events and co-interventions will also be measured. Data will be analysed according to intention to treat principles, using linear mixed models for continuous outcomes, Mann Whitney U tests for ordinal outcomes, and Chi-square, risk ratios and risk differences for dichotomous outcomes.DiscussionThis trial will determine the difference in outcomes between specific physiotherapy treatment tailored to each of the five subgroups versus advice which is recommended in guidelines as a suitable treatment for most people with a low back disorder.Trial registrationAustralia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12609000834257.

Preliminary evidence for the features of non-reducible discogenic low back pain: survey of an international physiotherapy expert panel with the Delphi technique

OBJECTIVES The lumbar intervertebral disc is a known source of low back pain (LBP). Various clinical features of discogenic pain have been proposed, but none have been validated. Several subgroups of discogenic pain have been hypothesised, with non-reducible discogenic pain (NRDP) proposed as a relevant clinical subgroup. The objectives of this study were to obtain consensus from an expert panel on the features of discogenic low back pain, the existence of subgroups of discogenic LBP, particularly NRDP, and the associated features of NRDP. DESIGN Three-round Delphi survey. PARTICIPANTS Twenty-one international physiotherapists with expertise in LBP. METHODS Panellists listed and ranked features that they believed to be indicative of discogenic pain and NRDP. On completion of Round 3, features with ≥50% agreement between panellists were deemed to have reached consensus. RESULTS After three rounds, 10 features of discogenic LBP were identified. Nineteen of the panellists believed that NRDP was a subgroup of discogenic LBP, and nine features of NRDP were identified. CONCLUSION This study provides preliminary validation for the features associated with discogenic LBP. It also provides evidence supporting the existence and features of NRDP as a separate clinical subgroup of discogenic LBP.

Individualized functional restoration as an adjunct to advice for lumbar disc herniation with associated radiculopathy. A preplanned subgroup analysis of a randomized controlled trial

BACKGROUND CONTEXT Physical therapy is commonly sought by people with lumbar disc herniation and associated radiculopathy. It is unclear whether physical therapy is effective for this population. PURPOSE To determine the effectiveness of physical therapist-delivered individualized functional restoration as an adjunct to guideline-based advice in people with lumbar disc herniation and associated radiculopathy. STUDY DESIGN This is a preplanned subgroup analysis of a multicenter parallel group randomized controlled trial. PATIENT SAMPLE The study included 54 participants with clinical features of radiculopathy (6-week to 6-month duration) and imaging showing a lumbar disc herniation. OUTCOME MEASURES Primary outcomes were activity limitation (Oswestry Disability Index) and separate 0-10 numerical pain rating scales for leg pain and back pain. Measures were taken at baseline and at 5, 10, 26, and 52 weeks. METHODS The participants were randomly allocated to receive either individualized functional restoration incorporating advice (10 sessions) or guideline-based advice alone (2 sessions) over a 10-week period. Treatment was administered by 11 physical therapists at private clinics in Melbourne, Australia. RESULTS Between-group differences for activity limitation favored the addition of individualized functional restoration to advice alone at 10 weeks (7.7, 95% confidence interval [CI] 0.3-15.1) and 52 weeks (8.2, 95% CI 0.7-15.6), as well as back pain at 10 weeks (1.4, 95% CI 0.2-2.7). There were no significant differences between groups for leg pain at any follow-up. Several secondary outcomes also favored individualized functional restoration over advice. CONCLUSIONS In participants with lumbar disc herniation and associated radiculopathy, an individualized functional restoration program incorporating advice led to greater reduction in activity limitation at 10- and 52-week follow-ups compared with guideline-based advice alone. Although back pain was significantly reduced at 10 weeks with individualized functional restoration, this effect was not maintained at later timepoints, and there were no significant effects on leg pain, relative to guideline-based advice.

Individualized Physical Therapy is Cost Effective Compared to Guideline-Based Advice for People with Low Back Disorders.

Study Design. A cost-utility analysis within a randomized controlled trial was conducted from the health care perspective. Objective. The aim of this study was to determine whether individualized physical therapy incorporating advice is cost-effective relative to guideline-based advice alone for people with low back pain and/or referred leg pain (≥6 weeks, ⩽6 months duration of symptoms). Summary of Background Data. Low back disorders are a burdensome and costly condition across the world. Cost-effective treatments are needed to address the global burden attributable to this condition. Methods. Three hundred participants were randomly allocated to receive either two sessions of guideline-based advice alone (n = 144), or 10 sessions of individualized physical therapy targeting pathoanatomical, psychosocial and neurophysiological factors, and incorporating advice (n = 156). Data relating to health care costs, health benefits (EuroQol-5D) and work absence were obtained from participants via questionnaires at 5, 10, 26, and 52-week follow-ups. Results. Total health care costs were similar for both groups: mean difference

Who Benefits Most From Individualized Physiotherapy or Advice for Low Back Disorders? A Preplanned Effect Modifier Analysis of a Randomized Controlled Trial:

27.03 [95% confidence interval (95% CI): -200.29 to 254.35]. Health benefits across the 12-month follow-up were significantly greater with individualized physical therapy: incremental quality-adjusted life years = 0.06 (95% CI: 0.02–0.10). The incremental cost-effectiveness ratio was

Individualised manual therapy plus guideline-based advice versus advice alone for people with clinical features of lumbar zygapophyseal joint pain: A randomised controlled trial

422 per quality-adjusted life year gained. The probability that individualized physical therapy was cost-effective reached 90% at a willingness-to-pay threshold of

STOPS trial versus Costa et al: a more accurate analysis

36,000. A saving of

Development Of A Multivariate Prognostic Model For Pain And Activity Limitation In People With Low Back Disorders Receiving Physiotherapy

1995.51 (95% CI: 143.98–3847.03) per worker in income was realized in the individualized physical therapy group relative to the advice group. Sensitivity and subgroup analyses all revealed a dominant position for individualized physical therapy; hence, the base case analysis was the most conservative. Conclusion. Ten sessions of individualized physical therapy incorporating advice is cost-effective compared with two sessions of guideline-based advice alone for people with low back disorders. Level of Evidence: 2

Individualised functional restoration plus guideline-based advice vs advice alone for non-reducible discogenic low back pain: a randomised controlled trial.

Study Design. A preplanned effect modifier analysis of the Specific Treatment of Problems of the Spine randomized controlled trial. Objective. To identify characteristics associated with larger or smaller treatment effects in people with low back disorders undergoing either individualized physical therapy or guideline-based advice. Summary of Background Data. Identifying subgroups of people who attain a larger or smaller benefit from particular treatments has been identified as a high research priority for low back disorders. Methods. The trial involved 300 participants with low back pain and/or referred leg pain (≥6 wk, ⩽6 mo duration), who satisfied criteria to be classified into five subgroups (with 228 participants classified into three subgroups relating to disc-related disorders, and 64 classified into the zygapophyseal joint dysfunction subgroup). Participants were randomly allocated to receive either two sessions of guideline based advice (n = 144), or 10 sessions of individualized physical therapy targeting pathoanatomical, psychosocial, and neurophysiological factors (n = 156). Univariate and multivariate linear mixed models determined the interaction between treatment group and potential effect modifiers (defined a priori) for the primary outcomes of back pain, leg pain (0–10 Numeric Rating Scale) and activity limitation (Oswestry Disability Index) over a 52-week follow-up. Results. Participants with higher levels of back pain, higher Örebro scores (indicative of higher risk of persistent pain) or longer duration of symptoms derived the largest benefits from individualized physical therapy relative to advice. Poorer coping also predicted larger benefits from individualized physical therapy in the univariate analysis. Conclusion. These findings suggest that people with low back disorders could be preferentially targeted for individualized physical therapy rather than advice if they have higher back pain levels, longer duration of symptoms, or higher Örebro scores. Level of Evidence: 2