The effectiveness of acupuncture and mindfulness-based stress reduction (MBSR) for patients with multiple sclerosis associated fatigue – A study protocol and its rationale for a randomized controlled trial

Abstract Introduction Fatigue plays an important role in the daily activity of patients with multiple sclerosis (MS) and strongly influences their quality of life. Numerous clinical trials evaluating various interventions for fatigue in MS have shown only minor benefits. The main aim of the present trial is to evaluate whether 1) acupuncture or 2) mindfulness-based stress reduction (MBSR) in addition to usual care are effective in reducing fatigue in MS patients compared to usual care alone. Methods Within a randomized, three-arm, controlled trial we aim to include 141 MS patients aged 18–65 years with fatigue for at least 3 months and an average score of ≥4 on the Fatigue Severity Scale (FSS). Patients will be randomized into three groups: an acupuncture group receiving 12 weeks of acupuncture in addition to usual care, a MBSR group receiving 12 weeks of MBSR in addition to usual care, and a usual care group continuing their previous treatment. Primary outcome is the Fatigue Severity Scale (FSS) after 12 weeks. To assess the trial’s characteristics regarding efficacy and effectiveness we used the pragmatic explanatory continuum summary (PRECIS-2). Discussion This trial addresses new therapeutic approaches for fatigue in MS. The resulting design is a compromise between scientific rigor and pragmatism. Due to difficulties with recruitment we had to scale down our trial to the groups of usual care and acupuncture. The trial's results will give first evidence whether acupuncture is effective in patients with MS associated fatigue. Trial registration ClinicalTrials.gov identifier NCT01864707, registered on 2 April 2013.