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

Abstract

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.