Fibromyalgia (FM), one of the most common rheumatologic diagnoses, is a condition of unknown etiology characterized by widespread muscle pain and stiffness, accompanied by a variety of other symptoms including sleep disturbance, headaches, irritable bowel syndrome, and psychological distress. Treatment is generally unsatisfactory and most randomized, controlled treatment trials have been unable to demonstrate a sustained effective intervention. Thus, it is not surprising that the vast majority of FM patients have tried complementary and alternative medicine (CAM) therapies. Reiki is a form of energy medicine in which practitioners reportedly access universal life energy to heal patients, either by direct contact at specific hand positions or from a distance. A vast body of anecdotal literature as well as 2 randomized controlled trials suggest that Reiki may be an effective treatment for FM, appearing to relieve pain and improve psychological well being. In addition, it appears to have no adverse effects and can eventually be self-administered, making it a low-risk, low-cost, potentially patient-empowering intervention. This study will investigate the efficacy of Reiki in the treatment of FM. 100 Reiki-naive FM patients will be recruited from a chronic fatigue referral clinic, and will undergo an 8-week, biweekly (16 treatments) trial. Patients will be randomized into 2 Reiki groups (direct-contact and distant Reiki) and 2 control (sham and placebo) groups. The sham Reiki practitioners will be professional actors who resemble the true Reiki practitioners but have no experience with health care or healing arts and are taught to mimic the Reiki Masters' verbal and physical interactions with the patients, while distracting whatever healing intention they may possess by doing mental arithmetic. The specific aims of this study are: 1) to evaluate the short and long-term efficacy and safety of an 8-week placebo-controlled randomized trial of both direct-contact and distant Reiki in the treatment of FM; 2) establish carefully constructed control groups for their feasibility and scientific usefulness for future trials of Reiki and other types of energy medicine; and 3) to collect pilot data for larger trials on the mechanism, safety, and duration of clinical and subjective effects of Reiki. Patients will be assessed at enrollment, 4 and 8 weeks during treatment and 12 weeks post-treatment. Our primary outcomes will be patient global assessment, subjective pain and mean number of tender points. Secondary outcomes will include pain threshold, sleep, fatigue, and psychological indicators. This pilot study could potentially impact the clinical care of the estimated 6 million Americans with FM, and shape the design of future larger, randomized, placebo-controlled trials of Reiki and other energy therapies.
NIH ExPorter
NIH ExPorter