Effectiveness of a multicomponent treatment versus conventional treatment in patients with fibromyalgia: Study protocol

BACKGROUND: Fibromyalgia (FM) is a chronic pain syndrome characterized by widespread musculoskeletal pain and multiple symptoms. It is a common clinical condition whose etiology is unclear. Currently, there is no gold standard treatment for FM. Management of this condition is therefore aimed at reducing symptoms and maintaining the individual's ability to function optimally. Based on the principal symptoms and characteristics of individuals with FM, we hypothesized that the implementation of a multicomponent treatment (with physical exercise, cognitive behavioral therapy adding to a graded motor imagery program, and therapeutic neuroscience education) would be more effective than conventional treatment in women with FM. This paper describes the rationale and methods of study intended to test the effectiveness of multicomponent treatment versus conventional treatment in patients with FM. METHOD/DESIGN: Fifty-six female individuals between 18 and 65 years of age, who were referred to the physical therapy department of the Rehabilitar Center in Chile, will be randomized into two treatment arms. The intervention group will receive a multicomponent treatment program for duration of 12 weeks. The control group will receive a conventional treatment for this condition for 12 weeks. The primary outcome measure will be the pain intensity score, measured by the numeric pain rating scale (NPRS), and the secondary outcomes will be the FM Impact Questionnaire (FIQ), and affective components of pain, such as catastrophizing using the Pain Catastrophizing Scale (PCS), fear of movement using the Tampa Scale Kinesiophobia (TSK), and sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI). DISCUSSION: This paper reports the design of a randomized clinical trial aimed at assessing the effectiveness of the multicomponent treatment versus conventional treatment in women with FM. TRIAL REGISTRATION: Brazilian registry of clinical trials UTN number U1111-1232-0862. Registered 22 April 2019.