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Regular paracetamol is the recommended first-line analgesic for acute low-back pain; however, no high-quality evidence supports this recommendation. We aimed to assess the efficacy of paracetamol taken regularly or as-needed to improve time to recovery from pain, compared with placebo, in patients with low-back pain. We did a multicentre, double-dummy, randomised, placebo controlled trial across 235 primary care centres in Sydney, Australia, from Nov 11, 2009, to March 5, 2013. We randomly allocated patients with acute low-back pain in a 1:1:1 ratio to receive up to 4 weeks of regular doses of paracetamol (three times per day; equivalent to 3990 mg paracetamol per day), as-needed doses of paracetamol (taken when needed for pain relief; maximum 4000 mg paracetamol per day), or placebo. Randomisation was done according to a centralised randomisation schedule prepared by a researcher who was not involved in patient recruitment or data collection. Patients and staff at all sites were masked to treatment allocation. All participants received best-evidence advice and were followed up for 3 months. The primary outcome was time until recovery from low-back pain, with recovery defined as a pain score of 0 or 1 (on a 0–10 pain scale) sustained for 7 consecutive days. All data were analysed by intention to treat. This study is registered with the Australian and New Zealand Clinical Trial Registry, number ACTN 12609000966291. 550 participants were assigned to the regular group (550 analysed), 549 were assigned to the as-needed group (546 analysed), and 553 were assigned to the placebo group (547 analysed). Median time to recovery was 17 days (95% CI 14–19) in the regular group, 17 days (15–20) in the as-needed group, and 16 days (14–20) in the placebo group (regular vs placebo hazard ratio 0·99, 95% CI 0·87–1·14; as-needed vs placebo 1·05, 0·92–1·19; regular vs as-needed 1·05, 0·92–1·20). We recorded no difference between treatment groups for time to recovery (adjusted p=0·79). Adherence to regular tablets (median tablets consumed per participant per day of maximum 6; 4·0 [IQR 1·6–5·7] in the regular group, 3·9 [1·5–5·6] in the as-needed group, and 4·0 [1·5–5·7] in the placebo group), and number of participants reporting adverse events (99 [18·5%] in the regular group, 99 [18·7%] in the as-needed group, and 98 [18·5%] in the placebo group) were similar between groups. Our findings suggest that regular or as-needed dosing with paracetamol does not affect recovery time compared with placebo in low-back pain, and question the universal endorsement of paracetamol in this patient group. National Health and Medical Research Council of Australia and GlaxoSmithKline Australia.

The impact of the relationship (therapeutic alliance) between patients and physical therapists on treatment outcome in the rehabilitation of patients with chronic low back pain (LBP) has not been previously investigated. The purpose of this study was to investigate whether the therapeutic alliance between physical therapists and patients with chronic LBP predicts clinical outcomes. This was a retrospective observational study nested within a randomized controlled trial. One hundred eighty-two patients with chronic LBP who volunteered for a randomized controlled trial that compared the efficacy of exercises and spinal manipulative therapy rated their alliance with physical therapists by completing the Working Alliance Inventory at the second treatment session. The primary outcomes of function, global perceived effect of treatment, pain, and disability were assessed before and after 8 weeks of treatment. Linear regression models were used to investigate whether the alliance was a predictor of outcome or moderated the effect of treatment. The therapeutic alliance was consistently a predictor of outcome for all the measures of treatment outcome. The therapeutic alliance moderated the effect of treatment on global perceived effect for 2 of 3 treatment contrasts (general exercise versus motor control exercise, spinal manipulative therapy versus motor control exercise). There was no treatment effect modification when outcome was measured with function, pain, and disability measures. Therapeutic alliance was measured at the second treatment session, which might have biased the interaction during initial stages of treatment. Data analysis was restricted to primary outcomes at 8 weeks. Positive therapeutic alliance ratings between physical therapists and patients are associated with improvements of outcomes in LBP. Future research should investigate the factors explaining this relationship and the impact of training interventions aimed at optimizing the alliance.

In a randomized trial involving patients with sciatica, the antiepileptic drug pregabalin, at a dose of up to 600 mg per day, was no more effective than placebo in reducing pain or disability over the course of 8 weeks and resulted in a higher incidence of adverse events. Sciatica is characterized by radiating posterior or posterolateral leg pain, which is sometimes accompanied by back pain, sensory loss, weakness, or reflex abnormalities. 1 – 3 Few clinical guidelines for the treatment of sciatica exist, and evidence regarding effective medical treatments is limited. 2 , 3 Treatment with pregabalin (Lyrica, Pfizer) has been shown to be effective in reducing some types of neuropathic pain, including postherpetic neuralgia and diabetic peripheral neuropathy, 4 , 5 as well as allodynia and hyperalgesia from several conditions, 6 – 8 and some guidelines recommend pregabalin for the treatment of pain with neuropathic features. 5 Pregabalin therefore represents a potential treatment for sciatica. Its . . .

The working alliance, or collaborative bond, between client and psychotherapist has been found to be related to outcome in psychotherapy. The purpose of this study was to investigate whether the working alliance is related to outcome in physical rehabilitation settings. A sensitive search of 6 databases identified a total of 1,600 titles. Prospective studies of patients undergoing physical rehabilitation were selected for this systematic review. For each included study, descriptive data regarding participants, interventions, and measures of alliance and outcome-as well as correlation data for alliance and outcomes-were extracted. Thirteen studies including patients with brain injury, musculoskeletal conditions, cardiac conditions, or multiple pathologies were retrieved. Various outcomes were measured, including pain, disability, quality of life, depression, adherence, and satisfaction with treatment. The alliance was most commonly measured with the Working Alliance Inventory, which was rated by both patient and therapist during the third or fourth treatment session. The results indicate that the alliance is positively associated with: (1) treatment adherence in patients with brain injury and patients with multiple pathologies seeking physical therapy, (2) depressive symptoms in patients with cardiac conditions and those with brain injury, (3) treatment satisfaction in patients with musculoskeletal conditions, and (4) physical function in geriatric patients and those with chronic low back pain. Among homogenous studies, there were insufficient reported data to allow pooling of results. From this review, the alliance between therapist and patient appears to have a positive effect on treatment outcome in physical rehabilitation settings; however, more research is needed to determine the strength of this association.

Evidence suggests that brief physiotherapy programmes are as effective for acute whiplash-associated disorders as more comprehensive programmes; however, whether this also holds true for chronic whiplash-associated disorders is unknown. We aimed to estimate the effectiveness of a comprehensive exercise programme delivered by physiotherapists compared with advice in people with a chronic whiplash-associated disorder. PROMISE is a two group, pragmatic randomised controlled trial in patients with chronic (>3 months and <5 years) grade 1 or 2 whiplash-associated disorder. Participants were randomly assigned by a computer-generated randomisation schedule to receive either the comprehensive exercise programme (20 sessions) or advice (one session and telephone support). Sealed opaque envelopes were used to conceal allocation. The primary outcome was pain intensity measured on a 0–10 scale. Outcomes were measured at baseline, 14 weeks, 6 months, and 12 months by a masked assessor. Analysis was by intention to treat, and treatment effects were calculated with linear mixed models. The trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12609000825257. 172 participants were allocated to either the comprehensive exercise programme (n=86) or advice group (n=86); 157 (91%) were followed up at 14 weeks, 145 (84%) at 6 months, and 150 (87%) at 12 months. A comprehensive exercise programme was not more effective than advice alone for pain reduction in the participants. At 14 weeks the treatment effect on a 0–10 pain scale was 0·0 (95% CI −0·7 to 0·7), at 6 months 0·2 (−0·5 to 1·0), and at 12 months −0·1 (−0·8 to 0·6). CNS hyperexcitability and symptoms of post-traumatic stress did not modify the effect of treatment. We recorded no serious adverse events. We have shown that simple advice is equally as effective as a more intense and comprehensive physiotherapy exercise programme. The need to identify effective and affordable strategies to prevent and treat acute through to chronic whiplash associated disorders is an important health priority. Future avenues of research might include improving understanding of the mechanisms responsible for persistent pain and disability, investigating the effectiveness and timing of drugs, and study of content and delivery of education and advice. The National Health and Medical Research Council of Australia, Motor Accidents Authority of New South Wales, and Motor Accident Insurance Commission of Queensland.

Executive functioning and self-regulation influence a range of outcomes across the life course including physical and mental health, educational success, and employment. Children prenatally exposed to alcohol or early life trauma (ELT) are at higher risk of impairment of these skills and may require intervention to address self-regulation deficits. Researchers partnered with the local Aboriginal health organization and schools to develop and pilot a manualized version of the Alert Program® in the Fitzroy Valley, north Western Australia, a region with documented high rates of fetal alcohol spectrum disorder and ELT. This self-controlled cluster randomized trial evaluated the effect of an 8-week Alert Program® intervention on children's executive functioning and self-regulation skills. Following parent or caregiver consent (referred to hereafter as parent), 271 students were enrolled in the study. This reflects a 75% participation rate and indicates the strong community support that exists for the study. Teachers from 26 primary school classrooms across eight Fitzroy Valley schools received training to deliver eight, one-hour Alert Program® lessons over eight-weeks to students. Student outcomes were measured by parent and teacher ratings of children's behavioral, emotional, and cognitive regulation. The mean number of lessons attended by children was 4.2. Although no significant improvements to children's executive functioning skills or behavior were detected via the teacher-rated measures as hypothesized, statistically significant improvements were noted on parent-rated measures of executive functioning and behavior. The effectiveness of future self-regulation programs may be enhanced through multimodal delivery through home, school and community based settings to maximize children's exposure to the intervention. Despite mixed findings of effect, this study was an important first step in adapting and evaluating the Alert Program® for use in remote Australian Aboriginal community schools, where access to self-regulation interventions is limited.

Previous systematic reviews have concluded that the effectiveness of motor control exercise for persistent low back pain has not been clearly established. The objective of this study was to systematically review randomized controlled trials evaluating the effectiveness of motor control exercises for persistent low back pain. Electronic databases were searched to June 2008. Pain, disability, and quality-of-life outcomes were extracted and converted to a common 0 to 100 scale. Where possible, trials were pooled using Revman 4.2. Fourteen trials were included. Seven trials compared motor control exercise with minimal intervention or evaluated it as a supplement to another treatment. Four trials compared motor control exercise with manual therapy. Five trials compared motor control exercise with another form of exercise. One trial compared motor control exercise with lumbar fusion surgery. The pooling revealed that motor control exercise was better than minimal intervention in reducing pain at short-term follow-up (weighted mean difference=-14.3 points, 95% confidence interval [CI]=-20.4 to -8.1), at intermediate follow-up (weighted mean difference=-13.6 points, 95% CI=-22.4 to -4.1), and at long-term follow-up (weighted mean difference=-14.4 points, 95% CI=-23.1 to -5.7) and in reducing disability at long-term follow-up (weighted mean difference=-10.8 points, 95% CI=-18.7 to -2.8). Motor control exercise was better than manual therapy for pain (weighted mean difference=-5.7 points, 95% CI=-10.7 to -0.8), disability (weighted mean difference=-4.0 points, 95% CI=-7.6 to -0.4), and quality-of-life outcomes (weighted mean difference=-6.0 points, 95% CI=-11.2 to -0.8) at intermediate follow-up and better than other forms of exercise in reducing disability at short-term follow-up (weighted mean difference=-5.1 points, 95% CI=-8.7 to -1.4). Motor control exercise is superior to minimal intervention and confers benefit when added to another therapy for pain at all time points and for disability at long-term follow-up. Motor control exercise is not more effective than manual therapy or other forms of exercise.

Motor control exercises to improve control and coordination of trunk muscles and graded activity under the principles of cognitive-behavioral therapy are 2 commonly used exercise therapies, yet there is little evidence to support the use of one intervention over the other. The objective of this study was to compare the effectiveness of motor control exercises and graded activity for patients with chronic nonspecific low back pain. This study was a prospectively registered randomized controlled trial with outcome assessment and statistical analyses conducted blind to group. The study was conducted in primary care settings. The participants were 172 patients with chronic (>12 weeks) nonspecific low back pain. Patients were randomly assigned to receive either motor control exercises or graded activity. There was no attempt to subclassify patients to match them to a treatment. Patients in both groups received 14 sessions of individualized, supervised exercise therapy. Primary outcomes were average pain over the previous week (numeric rating scale) and function (Patient-Specific Functional Scale); secondary outcomes were disability (24-item Roland-Morris Disability Questionnaire), global impression of change (Global Perceived Effect Scale), and quality of life (36-Item Short-Form Health Survey questionnaire [SF-36]). Outcome measures were collected at baseline and at 2, 6, and 12 months after intervention. A linear mixed models analysis showed that there were no significant differences between treatment groups at any of the time points for any of the outcomes studied. For example, the effect for pain at 2 months was 0.0 (-0.7 to 0.8). Clinicians could not be blinded to the interventions. results of this study suggest that motor control exercises and graded activity have similar effects for patients with chronic nonspecific low back pain.

Lack of standardization of terminology in low back pain (LBP) research has significantly impeded progress in this area. The diversity in existing definitions for a ‘recurrence of an episode of LBP’ and ‘recurrent LBP’ is an important example. The variety of definitions used by researchers working in this area has prevented comparison of results between trials and made meta-analyses of this data unfeasible. The aim of this study was to use a modified Delphi approach to gain consensus on definitions for a ‘recurrence of an episode of LBP’ (e.g. outcome event) and for ‘recurrent LBP’ (e.g. patient population). Existing definitions for both constructs were classified into the main features comprising the definition (e.g. ‘duration of pain’) and the items that defined each feature (e.g. ‘pain lasting at least 24 h’). In each round, participants were asked to rate the importance of each feature to a definition of a ‘recurrence of an episode of LBP’, and a definition of ‘recurrent LBP’ and rank the items (defining each feature) in order of decreasing importance. Forty-six experts in LBP research, from nine different countries, participated in this study. Four rounds were completed with responses rates of 94, 91, 83, and 97% in rounds 1, 2, 3, and 4, respectively. Consensus definitions were reached in both areas with 95% of panel members supporting the definition of a ‘recurrence of an episode of LBP’ and 92% of panel members supporting the definition of ‘recurrent LBP’. Future research is necessary to evaluate these definitions.

The evidence that exercise intervention is effective for treatment of chronic low back pain comes from trials that are not placebo-controlled. The purpose of this study was to investigate the efficacy of motor control exercise for people with chronic low back pain. This was a randomized, placebo-controlled trial. The study was conducted in an outpatient physical therapy department in Australia. Patients The participants were 154 patients with chronic low back pain of more than 12 weeks' duration. Twelve sessions of motor control exercise (ie, exercises designed to improve function of specific muscles of the low back region and the control of posture and movement) or placebo (ie, detuned ultrasound therapy and detuned short-wave therapy) were conducted over 8 weeks. Primary outcomes were pain intensity, activity (measured by the Patient-Specific Functional Scale), and patient's global impression of recovery measured at 2 months. Secondary outcomes were pain; activity (measured by the Patient-Specific Functional Scale); patient's global impression of recovery measured at 6 and 12 months; activity limitation (measured by the Roland-Morris Disability Questionnaire) at 2, 6, and 12 months; and risk of persistent or recurrent pain at 12 months. The exercise intervention improved activity and patient's global impression of recovery but did not clearly reduce pain at 2 months. The mean effect of exercise on activity (measured by the Patient-Specific Functional Scale) was 1.1 points (95% confidence interval [CI]=0.3 to 1.8), the mean effect on global impression of recovery was 1.5 points (95% CI=0.4 to 2.5), and the mean effect on pain was 0.9 points (95% CI=-0.01 to 1.8), all measured on 11-point scales. Secondary outcomes also favored motor control exercise. Limitation Clinicians could not be blinded to the intervention they provided. Motor control exercise produced short-term improvements in global impression of recovery and activity, but not pain, for people with chronic low back pain. Most of the effects observed in the short term were maintained at the 6- and 12-month follow-ups.