The RELAX randomized controlled trial: Stretching versus meditation for nocturnal muscle cramps

Abstract

AbstractBackgroundMuscle cramps are common among persons with cirrhosis and are associated with poor health‐related quality of life (HRQOL). Treatment options are limited. We compared stretching or meditation in a randomized‐controlled trial (RCT).PatientsWe enrolled 98 patients with a history of >4 muscle cramps in the prior month from 7/22–7/23. We randomized patients 1:1 to stretching versus meditation for 35 days. Our primary outcome was the change in cramp severity measured by the visual analogue scale for cramps (VAS‐cramps, scaled 0–10). Secondary outcomes included a patient global impression of change (PGIC), change in sleep quality and global HRQOL measured using the EQ‐5D and VAS‐global HRQOL.ResultsOverall, 48% of patients had cirrhosis, 40% had diabetes, 16% the median age was 63, most were women (67%) and 81% were college educated. Both arms experienced a reduction in cramp severity—a median of 1.44 (.58–2.29) points for stretching and 1.97 (1.01–2.93) points for meditation. These changes were significant changes from baseline (p = .001 for stretching, p < .0001 for meditation) but these changes were equivalent between arms (p = .4). The PGIC was improved: 1.33 (1.02–1.65) for stretching, 1.05 (.70–1.41) for meditation, p‐difference .2. Sleep was also improved for both. HRQOL did not change according to the Eq5D; according to the VAS, HRQOL rose for meditation by 6 (.1–11.8) points but not for stretching. More patients recommended stretching than meditation (79.2% vs. 55.3%, p = .02).ConclusionIn a randomized trial, stretching and meditation both reduced cramp severity and improved sleep quality and global impression of change. While patients preferred stretching, there was no difference in effect between arms.