Title: Counterstrain manipulation in the treatment of Restless Legs Syndrome: a pilot single-blind randomised controlled trial; the CARL Trial

Objective A single-blind randomised controlled trial was conducted to test the efficacy of Longden’s counterstrain technique for restless legs syndrome (RLS) and the feasibility of the trial methodology. Methods Participants were adults with moderate to severe and persistent RLS, randomized to receive either active or control intervention. The control intervention (B) involved 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 (IRLS) total score at six weeks, showed a statistically significant difference of 8·06 points (95% CI 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 six weeks. Trials of longer term effects and comparison with the standard drug regimes are now required. Introduction Restless Legs Syndrome (RLS), described by Ekbom in 1945, is a condition characterized by a strong inclination to move limbs, usually the legs, that comes on most frequently in bed at night but may occur at rest while sitting. Movement temporarily alleviates the symptoms but the resulting interference with sleep or sitting can be inconvenient and exhausting3. The condition is usually persistent once established 4-6. The prevalence of the condition has been reported to be as great as 2.7% of the general population suffering moderate or severe symptoms 2 – 3 times per week 7-9 . The clinical features of a symmetrical movement disorder with no local neurological abnormality has suggested a central mechanism although a distinction from other such disorders is that the movement is not totally involuntary: while the final form it takes is voluntary, the impulse to move is neither desired nor deniable. Treatment has generally been by centrally-acting classes of drugs: dopamine agonists eg. pergolide 10and ropinirole 11, benzodiazepines such as clonazepam, anticonvulsants or opioids. Partial suppression of the symptoms can be achieved during treatment with relapse usual when the drug is discontinued. Counterstrain is a manual treatment method discovered by Jones12, a US osteopathic physician. The procedure involves locating the specific tender ‘Jones’ points in the