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

OBJECTIVES: To determine whether individualised manual therapy plus guideline-based advice results in superior outcomes to advice alone in participants with clinical features potentially indicative of lumbar zygapophyseal joint pain. DESIGN: Multi centre parallel group randomised controlled trial. SETTING: 14 physiotherapy clinics in Melbourne, Australia. PARTICIPANTS: Sixty-four participants with clinical features potentially indicative of lumbar zygapophyseal joint pain. INTERVENTIONS: 10-weeks of physiotherapy comprising individualised manual therapy based on pathoanatomical, psychosocial and neurophysiological barriers to recovery plus guideline-based advice (10 sessions) or advice alone (two sessions). MAIN OUTCOME MEASURES: Primary outcomes were activity limitation (Oswestry Disability Index), and separate 0 to 10 numerical rating scales for leg pain and back pain. Measures were taken at baseline and 5, 10, 26 and 52-week. RESULTS: Between-group differences for back pain favoured individualised manual therapy over advice for back pain at 5 (1.0; 95% CI 0.6 to 2.0), 10 (1.5; 95% CI 0.5 to 2.4) and 26-weeks (1.4; 95% CI 0.4 to 2.3) as well as for activity limitation at 26 (8.3; 95% CI 2.6 to 14.2) and 52-weeks (8.2; 95% CI 2.3 to 14.2). There were no significant between-group differences for leg pain. Secondary outcomes and responder analyses also favoured individualised manual therapy at almost all time-points. CONCLUSIONS: In participants with clinical features potentially indicative of lumbar zygapophyseal joint pain, individualised manual therapy led to greater reduction in back pain at 5, 10 and 26-week follow-up as well as activity limitation at 26 and 52-weeks. Between-group differences were likely to be clinically important. TRIAL REGISTRATION: ACTRN12609000334202.

Development of a Multivariate Prognostic Model for Pain and Activity Limitation in People With Low Back Disorders Receiving Physiotherapy.

OBJECTIVE: To identify predictors for back pain, leg pain, and activity limitation in patients with early persistent low back disorders (LBDs). DESIGN: Prospective inception cohort study. SETTING: Primary care private physiotherapy clinics in Melbourne, Australia. PARTICIPANTS: Individuals (N=300) aged 18-65 years with low back and/or referred leg pain of ≥6 weeks and ≤6 months duration. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Numeric rating scales for back pain and leg pain as well as the Oswestry Disability Scale. RESULTS: Prognostic factors included sociodemographics, treatment related factors, subjective/physical examination, subgrouping factors, and standardized questionnaires. Univariate analysis followed by generalized estimating equations were used to develop a multivariate prognostic model for back pain, leg pain, and activity limitation. Fifty-eight prognostic factors progressed to the multivariate stage where 15 showed significant (P<.05) associations with at least 1 of the 3 outcomes. There were 5 indicators of positive outcome (2 types of LBD subgroups, paresthesia below waist, walking as an easing factor, and low transversus abdominis tone) and 10 indicators of negative outcome (both parents born overseas, deep leg symptoms, longer sick leave duration, high multifidus tone, clinically determined inflammation, higher back and leg pain severity, lower lifting capacity, lower work capacity, and higher pain drawing percentage coverage). The preliminary model identifying predictors of LBDs explained up to 37% of the variance in outcome. CONCLUSIONS: This study evaluated a comprehensive range of prognostic factors reflective of both the biomedical and psychosocial domains of LBDs. The preliminary multivariate model requires further validation before being considered for clinical use.

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

Individualized Physical Therapy Is Cost-Effective Compared With 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 $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 $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 $36,000. A saving of $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.

OBJECTIVES: To evaluate the effectiveness of individualised functional restoration plus guideline-based advice compared to advice alone in people with non-reducible discogenic pain (NRDP). DESIGN: Subgroup analysis within a multicentre, parallel group randomised controlled trial. SETTING: Fifteen primary care physiotherapy clinics. PARTICIPANTS: Ninety-six participants with clinical features indicative of NRDP (6 week to 6 month duration of injury). INTERVENTIONS: Over a 10 week period physiotherapists provided 10 sessions of individualised functional restoration plus guideline-based advice or two sessions of advice alone MAIN OUTCOME MEASURES: Primary outcomes were back and leg pain (separate numerical rating scales) and activity limitation (Oswestry Disability Index). RESULTS: Between-group differences favoured individualised functional restoration over advice for back pain (1.1, 95% CI 0.1 to 2.1), leg pain (1.5, 95% CI 0.4 to 2.6) and Oswestry (6.3, 95% CI 1.3 to 11.4) at 10 weeks as well as Oswestry at 26 weeks (6.6, 95% CI 1.4 to 11.8). Secondary outcomes and responder analyses also favoured physiotherapy functional restoration suggesting the differences were clinically important. CONCLUSIONS: In people with NRDP of ≥6 weeks and ≤6 months duration, individualised functional restoration was more effective than advice for all primary outcomes at 10 weeks and sustained at 26 weeks for activity limitation. Our results suggest that for people with NRDP not recovering after 6 weeks, an individualised physiotherapy functional restoration program should be considered. CONTRIBUTION OF PAPER: (1) A physiotherapist delivered functional restoration program individualised to pathoanatomical, psychosocial and neurophysiological barriers and incorporating guideline-based advice was more effective than advice alone in people with non-reducible discogenic low back pain of ≥6 weeks and ≤6 months duration. (2) This trial differs significantly from other studies on individualised physiotherapy, as it investigates a conservative management program that specifically targets the pathoanatomical subgroup non-reducible discogenic pain. ACTRN numbers: ACTRN12609000412235; ACTRN12609000834257.

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.

Effects of individualised directional preference management versus advice for reducible discogenic pain: A pre-planned secondary analysis of a randomised controlled trial.

BACKGROUND: Low back disorders are prevalent and directional preference management is a common treatment with mixed evidence for effectiveness. OBJECTIVES: To determine the effectiveness of individualised directional preference management plus guideline-based advice versus advice alone in participants with reducible discogenic pain of 6-week to 6-month duration. DESIGN: Pre-planned secondary analysis of a multicentre, parallel group randomised controlled trial. METHODS: Participants were randomly allocated to receive a 10-week physiotherapy program of 10-sessions of individualised directional preference management plus guideline-based advice (n = 40) or 2-sessions of advice alone (n = 38). Primary outcomes were back pain, leg pain and activity limitation. Outcomes were taken at baseline and 5, 10, 26, and 52-weeks. RESULTS: Between-group differences significantly favoured directional preference management compared with advice for back pain at 5-weeks (1.28; 95% CI 0.34-2.23) and 10-weeks (1.45; 95% CI 0.51-2.40), and leg pain at 10-weeks (1.21; 95% CI 0.04-2.39). These short-term differences were not maintained. There were no significant differences between-groups for activity limitation. Secondary outcomes and responder analyses favoured directional preference management suggesting between-group differences were clinically important. CONCLUSIONS: In people with reducible discogenic pain, individualised directional preference management plus guideline-based advice resulted in significant and rapid improvement in short-term back and leg pain compared with advice alone. These effects were not maintained at long-term and there were no differences in activity limitation. Individualised directional preference management could be considered for patients with reducible discogenic pain seeking rapid pain relief however further research is indicated.

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.

BACKGROUND: Low 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/DESIGN: A 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. DISCUSSION: This 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 REGISTRATION: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12609000834257.