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

Abstract

Objective

A single-blind randomized controlled trial was conducted to test the efficacy of Longden's counterstrain technique for restless legs syndrome (RLS).

Methods

Participants were adults with moderate-to-severe and persistent RLS, randomized to receive either active or control intervention. The control intervention (B) involved in counterstrain manipulation applied to the lower half of the body. The active intervention (A) was identical to the control intervention plus specific modifications to treat RLS as described by Longden. The success of blinding of participants was confirmed by a questionnaire.

Results

Thirty-nine patients entered the trial, 20 assigned to Group A and 19 to Group B. All patients were included in the intention-to-treat analysis. The primary outcome measure, the change on the International Restless 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 the active 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.

Keywords:

• Musculoskeletal manipulations
• Osteopathic medicine
• Counterstrain
• Restless legs syndrome
• Randomized controlled trial

Acknowledgements

We are grateful for advice on trial design by Damien Ridge, Complementary and Alternative Medicine Reader in the School of Integrated Health, University of Westminster and other members of their faculty. We are grateful to the Osteopathic Trusts and the College of Osteopaths who provided clinic space and reception services without charge and the Association for Medical Osteopathy who provided some funding.