Janine Leach

A randomized controlled pilot trial of positional release manipulation (counterstrain) in the treatment of restless legs syndrome

Abstract Background Restless legs syndrome (RLS) sufferers are affected, often lifelong, with more than 1% of the population losing significant amounts of sleep on the majority of nights and only suppressive drug treatment being currently available. Both in our clinical practice and a 20-patient cohort study, a specific manipulative treatment has shown sufficient promise that a pilot randomized controlled trial is indicated. Methods a single-blind randomized controlled trial is proposed observing sufferers of RLS over 6 weeks. Participants treated with manipulation including the study technique will be compared with control patients receiving a similar treatment but lacking that technique. At 6 weeks, internationally validated outcome measures of severity and change will be applied. Discussion Demonstration of benefit from a course of manipulation that lessened or removed the need for drug treatment would change the management of RLS and stimulate reconsideration of present ideas about the mechanisms involved in RLS and the action of manipulation. Definitive RCTs evaluating the long-term benefits of manipulation compared with medication would become desirable.

Non-specific mechanisms in orthodox and CAM management of low back pain (MOCAM): theoretical framework and protocol for a prospective cohort study.

Introduction Components other than the active ingredients of treatment can have substantial effects on pain and disability. Such ‘non-specific’ components include: the therapeutic relationship, the healthcare environment, incidental treatment characteristics, patients’ beliefs and practitioners’ beliefs. This study aims to: identify the most powerful non-specific treatment components for low back pain (LBP), compare their effects on patient outcomes across orthodox (physiotherapy) and complementary (osteopathy, acupuncture) therapies, test which theoretically derived mechanistic pathways explain the effects of non-specific components and identify similarities and differences between the therapies on patient–practitioner interactions. Methods and analysis This research comprises a prospective questionnaire-based cohort study with a nested mixed-methods study. A minimum of 144 practitioners will be recruited from public and private sector settings (48 physiotherapists, 48 osteopaths and 48 acupuncturists). Practitioners are asked to recruit 10–30 patients each, by handing out invitation packs to adult patients presenting with a new episode of LBP. The planned multilevel analysis requires a final sample size of 690 patients to detect correlations between predictors, hypothesised mediators and the primary outcome (self-reported back-related disability on the Roland-Morris Disability Questionnaire). Practitioners and patients complete questionnaires measuring non-specific treatment components, mediators and outcomes at: baseline (time 1: after the first consultation for a new episode of LBP), during treatment (time 2: 2 weeks post-baseline) and short-term outcome (time 3: 3 months post-baseline). A randomly selected subsample of participants in the questionnaire study will be invited to take part in a nested mixed-methods study of patient–practitioner interactions. In the nested study, 63 consultations (21/therapy) will be audio-recorded and analysed quantitatively and qualitatively, to identify communication practices associated with patient outcomes. Ethics and dissemination The protocol is approved by the host institutions ethics committee and the NHS Health Research Authority Research Ethics Committee. Results will be disseminated via peer-reviewed journal articles, conferences and a stakeholder workshop.