Counterstrain manipulation in the treatment of restless legs syndrome: a pilot single-blind randomized controlled trial; the CARL Trial

Objective: A single-blind randomized controlled trial was conducted to test the efficacy of Longden’scounterstrain technique for restless legs syndrome (RLS).Methods: Participants were adults with moderate-to-severe and persistent RLS, randomized to receive eitheractive or control intervention. The control intervention (B) involved in counterstrain manipulation applied to thelower half of the body. The active intervention (A) was identical to the control intervention plus specificmodifications to treat RLS as described by Longden. The success of blinding of participants wasconfirmed by a questionnaire.Results: Thirty-nine patients entered the trial, 20 assigned to Group A and 19 to Group B. All patients wereincluded in the intention-to-treat analysis. The primary outcome measure, the change on the InternationalRestless Legs Scale total score at 6 weeks, showed a statistically significant difference of 8.06 points(95% confidence interval 3.15–12.96) between groups. This represented an improvement of 42.2% in theactive group compared to 8.7% in the controls. No adverse effects were reported.Conclusions: Longden’s RLS-specific counterstrain treatment had a clinically important effect at 6 weeks.Trials of longer-term effects and comparison with the standard drug regimes are now required.