Effect of diagnostic labelling on management intentions for non-specific low back pain: A randomized scenario-based experiment.

BACKGROUND: Diagnostic labels may influence treatment intentions. We examined the effect of labelling low back pain (LBP) on beliefs about imaging, surgery, second opinion, seriousness, recovery, work, and physical activities. METHODS: Six-arm online randomized experiment with blinded participants with and without LBP. Participants received one of six labels: 'disc bulge', 'degeneration', 'arthritis', 'lumbar sprain', 'non-specific LBP', 'episode of back pain'. The primary outcome was the belief about the need for imaging. RESULTS: A total of 1375 participants (mean [SD] age, 41.7 years [18.4 years]; 748 women [54.4%]) were included. The need for imaging was rated lower with the labels 'episode of back pain' (4.2 [2.9]), 'lumbar sprain' (4.2 [2.9]) and 'non-specific LBP' (4.4 [3.0]) compared to the labels 'arthritis' (6.0 [2.9]), 'degeneration' (5.7 [3.2]) and 'disc bulge' (5.7 [3.1]). The same labels led to higher recovery expectations and lower ratings of need for a second opinion, surgery and perceived seriousness compared to 'disc bulge', 'degeneration' and 'arthritis'. Differences were larger amongst participants with current LBP who had a history of seeking care. No differences were found in beliefs about physical activity and work between the six labels. CONCLUSIONS: 'Episode of back pain', 'lumbar sprain' and 'non-specific LBP' reduced need for imaging, surgery and second opinion compared to 'arthritis', 'degeneration' and 'disc bulge' amongst public and patients with LBP as well as reducing the perceived seriousness of LBP and enhancing recovery expectations. The impact of labels appears most relevant amongst those at risk of poor outcomes (participants with current LBP who had a history of seeking care).

The RESOLVE Trial for people with chronic low back pain: statistical analysis plan.

BACKGROUND: Statistical analysis plans describe the planned data management and analysis for clinical trials. This supports transparent reporting and interpretation of clinical trial results. This paper reports the statistical analysis plan for the RESOLVE clinical trial. The RESOLVE trial assigned participants with chronic low back pain to graded sensory-motor precision training or sham-control. RESULTS: We report the planned data management and analysis for the primary and secondary outcomes. The primary outcome is pain intensity at 18-weeks post randomization. We will use mixed-effects models to analyze the primary and secondary outcomes by intention-to-treat. We will report adverse effects in full. We also describe analyses if there is non-adherence to the interventions, data management procedures, and our planned reporting of results. CONCLUSION: This statistical analysis plan will minimize the potential for bias in the analysis and reporting of results from the RESOLVE trial. TRIAL REGISTRATION: ACTRN12615000610538 (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368619).

The effectiveness of the McKenzie method in addition to first-line care for acute low back pain: a randomized controlled trial.

BACKGROUND: Low back pain is a highly prevalent and disabling condition worldwide. Clinical guidelines for the management of patients with acute low back pain recommend first-line treatment consisting of advice, reassurance and simple analgesics. Exercise is also commonly prescribed to these patients. The primary aim of this study was to evaluate the short-term effect of adding the McKenzie method to the first-line care of patients with acute low back pain. METHODS: A multi-centre randomized controlled trial with a 3-month follow-up was conducted between September 2005 and June 2008. Patients seeking care for acute non-specific low back pain from primary care medical practices were screened. Eligible participants were assigned to receive a treatment programme based on the McKenzie method and first-line care (advice, reassurance and time-contingent acetaminophen) or first-line care alone, for 3 weeks. Primary outcome measures included pain (0-10 Numeric Rating Scale) over the first seven days, pain at 1 week, pain at 3 weeks and global perceived effect (-5 to 5 scale) at 3 weeks. Treatment effects were estimated using linear mixed models. RESULTS: One hundred and forty-eight participants were randomized into study groups, of whom 138 (93%) completed the last follow-up. The addition of the McKenzie method to first-line care produced statistically significant but small reductions in pain when compared to first-line care alone: mean of -0.4 points (95% confidence interval, -0.8 to -0.1) at 1 week, -0.7 points (95% confidence interval, -1.2 to -0.1) at 3 weeks, and -0.3 points (95% confidence interval, -0.5 to -0.0) over the first 7 days. Patients receiving the McKenzie method did not show additional effects on global perceived effect, disability, function or on the risk of persistent symptoms. These patients sought less additional health care than those receiving only first-line care (P = 0.002). CONCLUSIONS: When added to the currently recommended first-line care of acute low back pain, a treatment programme based on the McKenzie method does not produce appreciable additional short-term improvements in pain, disability, function or global perceived effect. However, the McKenzie method seems to reduce health utilization although it does not reduce patient's risk of developing persistent symptoms. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12605000032651.

Can rate of recovery be predicted in patients with acute low back pain? Development of a clinical prediction rule.

Some patients with low back pain recover quickly while others continue to experience pain beyond 3 months. The primary aim of this study was to develop a simple prediction rule to help clinicians identify patients with acute low back pain likely to recover at different rates. The secondary aim was to compare a clinician's prognosis judgement to the prediction rule. The study sample included 239 patients with acute low back pain who participated in a randomised controlled trial. The primary outcome was days to recovery from pain. Potential prognostic factors were initially tested for univariate association with recovery using Cox regression (p<0.1). Continuous prognostic factors with a significant association were dichotomised using a median split. Significantly associated prognostic factors were then included in a multivariate forward stepwise Cox regression. We then separated participants into strata according to the number of predictors in the final model for which they were positive. Our results suggest that a clinical prediction rule using three simple prognostic factors was able to differentiate between patients who recover quickly and those who recover slowly. Patients with lower than average initial pain intensity, shorter duration of symptoms and fewer previous episodes recovered more quickly (HR=3.5, 95% CI, 1.8-7.0) than patients without these characteristics. Therapists were able to predict patients likely to recover at different rates, (HR=1.6, 95% CI, 1.2-2.1), however, they did not perform as well as the clinical prediction rule. The rule requires validation in a different sample of patients.

Patient and clinician treatment preferences do not moderate the effect of exercise treatment in chronic whiplash-associated disorders.

An issue that arises when selecting therapy is whether patient or clinician preferences for treatment moderate the effect of treatment. To evaluate this question we conducted a secondary analysis of the results of a randomized controlled trial of exercise treatment of chronic whiplash. Immediately prior to randomization, treatment preference ratings were collected from each patient and from the physiotherapist who assessed each patient. Patients were then randomized to receive advice alone or exercise and advice with the primary treatment outcomes of pain and function measured immediately after conclusion of treatment. Treatment effect modification was evaluated with a treatment group by preference interaction term in the regression analyses. The analysis revealed that neither patient nor therapist treatment preferences moderated the effect of exercise treatment for chronic whiplash. The interaction effect of treatment group by patient preference was 0.1 (-0.3 to 0.5, p=0.68) on the 0-10 pain intensity scale and -0.1 (-0.5 to 0.3, p=0.64) on the 0-10 function scale. The interaction effect of treatment group by therapist preference was 0.0 (-0.3 to 0.4, p=0.786) on the 0-10 pain intensity scale and -0.2 (-0.4 to 0.1, p=0.296) on the 0-10 function scale. Our findings do not provide evidence that patient or therapist treatment preferences moderate the effect of exercise treatment for chronic whiplash.

Efficacy of manipulation for non-specific neck pain of recent onset: design of a randomised controlled trial.

BACKGROUND: Manipulation is a common treatment for non-specific neck pain. Neck manipulation, unlike gentler forms of manual therapy such as mobilisation, is associated with a small risk of serious neurovascular injury and can result in stroke or death. It is thought however, that neck manipulation provides better results than mobilisation where clinically indicated. There is long standing and vigorous debate both within and between the professions that use neck manipulation as well as the wider scientific community as to whether neck manipulation potentially does more harm than good. The primary aim of this study is to determine whether neck manipulation provides more rapid resolution of an episode of neck pain than mobilisation. METHODS/DESIGN: 182 participants with acute and sub-acute neck pain will be recruited from physiotherapy, chiropractic and osteopathy practices in Sydney, Australia. Participants will be randomly allocated to treatment with either manipulation or mobilisation. Randomisation will occur after the treating practitioner decides that manipulation is an appropriate treatment for the individual participant. Both groups will receive at least 4 treatments over 2 weeks. The primary outcome is number of days taken to recover from the episode of neck pain. Cox regression will be used to compare survival curves for time to recovery for the manipulation and mobilisation treatment groups. DISCUSSION: This paper presents the rationale and design of a randomised controlled trial to compare the effectiveness of neck manipulation and neck mobilisation for acute and subacute neck pain.

Randomized controlled trial of exercise for chronic whiplash-associated disorders.

Whiplash-associated disorders are common and incur considerable expense in social and economic terms. There are no known effective treatments for those people whose pain and disability persist beyond 3 months. We conducted a randomized, assessor-blinded, controlled trial at two centres in Australia. All participants received 3 advice sessions. In addition the experimental group participated in 12 exercise sessions over 6 weeks. Primary outcomes were pain intensity, pain bothersomeness and function measured at 6 weeks and 12 months. Exercise and advice was more effective than advice alone at 6 weeks for all primary outcomes but not at 12 months. The effect of exercise on the 0-10 pain intensity scale was -1.1 (95%CI -1.8 to -0.3, p=0.005) at 6 weeks and -0.2 (0.6 to -1.0, p=0.59) at 12 months; on the bothersomeness scale the effect was -1.0 (-1.9 to -0.2, p=0.003) at 6 weeks and 0.3 (-0.6 to 1.3, p=0.48) at 12 months. The effect on function was 0.9 (0.3 to 1.6, p=0.006) at 6 weeks and 0.6 (-0.1 to 1.4, p=0.10) at 12 months. High levels of baseline pain intensity were associated with greater treatment effects at 6 weeks and high levels of baseline disability were associated with greater treatment effects at 12 months. In the short-term exercise and advice is slightly more effective than advice alone for people with persisting pain and disability following whiplash. Exercise is more effective for subjects with higher baseline pain and disability.

The Cumberland ankle instability tool: a report of validity and reliability testing.

OBJECTIVE: To test the Cumberland Ankle Instability Tool (CAIT), a 9-item 30-point scale, for measuring severity of functional ankle instability. DESIGN: Cross-sectional study. SETTING: General community. PARTICIPANTS: Volunteer sample of 236 subjects. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Concurrent validity by comparison with the Lower Extremity Functional Scale (LEFS) and a visual analog scale (VAS) of global perception of ankle instability by using the Spearman rho. Construct validity and internal reliability with Rasch analysis using goodness-of-fit statistics for items and subjects, separation of subjects, correlation of items to the total scale, and a Cronbach alpha equivalent. Discrimination score for functional ankle instability by maximizing the Youden index and tested for sensitivity and specificity. Test-retest reliability by intraclass correlation coefficient, model 2,1 (ICC(2,1)). RESULTS: There were significant correlations between the CAIT and LEFS (rho=.50, P<.01) and VAS (rho=.76, P<.01). Construct validity and internal reliability were acceptable (alpha=.83; point measure correlation for all items, >0.5; item reliability index, .99). The threshold CAIT score was 27.5 (Youden index, 68.1); sensitivity was 82.9% and specificity was 74.7%. Test-retest reliability was excellent (ICC(2,1)=.96). CONCLUSIONS: CAIT is a simple, valid, and reliable tool to measure severity of functional ankle instability.

The McKenzie Method for the management of acute non-specific low back pain: design of a randomised controlled trial [ACTRN012605000032651].

BACKGROUND: Low back pain (LBP) is a major health problem. Effective treatment of acute LBP is important because it prevents patients from developing chronic LBP, the stage of LBP that requires costly and more complex treatment. Physiotherapists commonly use a system of diagnosis and exercise prescription called the McKenzie Method to manage patients with LBP. However, there is insufficient evidence to support the use of the McKenzie Method for these patients. We have designed a randomised controlled trial to evaluate whether the addition of the McKenzie Method to general practitioner care results in better outcomes than general practitioner care alone for patients with acute LBP. METHODS/DESIGN: This paper describes the protocol for a trial examining the effects of the McKenzie Method in the treatment of acute non-specific LBP. One hundred and forty eight participants who present to general medical practitioners with a new episode of acute non-specific LBP will be randomised to receive general practitioner care or general practitioner care plus a program of care based on the McKenzie Method. The primary outcomes are average pain during week 1, pain at week 1 and 3 and global perceived effect at week 3. DISCUSSION: This trial will provide the first rigorous test of the effectiveness of the McKenzie Method for acute non-specific LBP.

Advice or exercise for chronic whiplash disorders? Design of a randomized controlled trial.

BACKGROUND: Whiplash-associated disorder (or "whiplash") is a common condition incurring considerable expense in social and economic terms. A lack of research on effective therapy for patients with chronic whiplash associated disorders prompted the design of the current study. The primary aim of this randomised controlled trial is to determine the effects of a physical activity program for people with chronic (symptoms of > 3 months duration) whiplash. A secondary aim is to determine if pain severity, level of disability and fear of movement/(re)injury predict response to a physical activity program. METHODS/DESIGN: This paper presents the rationale and design of a randomised controlled trial examining the effects of advice and individualized sub-maximal exercise programs in the treatment of whiplash associated disorders. DISCUSSION: This paper highlights the design, methods and operational aspects of a significant clinical trial in the area of whiplash and chronic pain.

Effects of stretching before and after exercising on muscle soreness and risk of injury: systematic review.

OBJECTIVE: To determine the effects of stretching before and after exercising on muscle soreness after exercise, risk of injury, and athletic performance. METHOD: Systematic review. DATA SOURCES: Randomised or quasi-randomised studies identified by searching Medline, Embase, CINAHL, SPORTDiscus, and PEDro, and by recursive checking of bibliographies. MAIN OUTCOME MEASURES: Muscle soreness, incidence of injury, athletic performance. RESULTS: Five studies, all of moderate quality, reported sufficient data on the effects of stretching on muscle soreness to be included in the analysis. Outcomes seemed homogeneous. Stretching produced small and statistically non-significant reductions in muscle soreness. The pooled estimate of reduction in muscle soreness 24 hours after exercising was only 0.9 mm on a 100 mm scale (95% confidence interval -2.6 mm to 4.4 mm). Data from two studies on army recruits in military training show that muscle stretching before exercising does not produce useful reductions in injury risk (pooled hazard ratio 0.95, 0.78 to 1.16). CONCLUSIONS: Stretching before or after exercising does not confer protection from muscle soreness. Stretching before exercising does not seem to confer a practically useful reduction in the risk of injury, but the generality of this finding needs testing. Insufficient research has been done with which to determine the effects of stretching on sporting performance.