Effectiveness of a novel multicomponent treatment in women with fibromyalgia: A randomized clinical trial

Background: Multicomponent treatment is commonly used. However, there are no studies that included graded motor imagery and therapeutic neuroscience education to multicomponent treatment for patients with fibromyalgia This study aims to compare the short-term effects (at 12 weeks) of a multicomponent treatment combined with graded motor imagery and therapeutic neuroscience education versus standard treatment in patients with FM. Methods: The study was a single-blinded randomized controlled trial. Sixty-five women with a clinical diagnosis of FM were randomly allocated (1:1) into two groups. The experimental group (n = 33) received a novel multicomponent treatment combined with graded motor imagery and neuroscience education. The control group (n = 32) received a standard treatment including pharmacotherapy and standard physician education. The primary outcome was pain intensity assessed with the Numeric Pain Rating Scale (NPRS). The secondary outcomes were changes in the Fibromyalgia Impact Questionnaire (FIQ), the Pain Catastrophizing Scale (PCS), the Tampa Scale of Kinesiophobia (TSK-17), and the Pittsburgh Sleep Quality Index (PSQI) scores. All outcomes were assessed at baseline and 12 weeks. Results: All of the participants completed the trial. The between-group mean differences at 12 weeks were: NPRS-1.18 points (95% confidence interval [CI] -0.4 to -1.8; η² = 0.47; p <.001); FIQ-16.21 points (95% CI -10.9 to -22.1; η² = 0.58; p <.001); PCS total domain −12.5 points (95% CI -7.2 to -17.8; η² = 0.61; p <.001); TSK-17-6.15 points (95% CI -3.5 to -8.7; η² = 0.52; p <.001); and PSQI-2.74 points (95% CI -1.4 to 4.0; η² = 0.54; p <.001). All differences were statistically significant in favor of the novel multicomponent treatment group and had a large effect size. Conclusions: In the short term, a novel multicomponent treatment, including graded motor imagery and neuroscience education, was an effective therapeutic intervention for improving clinical outcomes compared with standard treatment in women with FM. Additional studies are needed to support long-term clinical effectiveness in these patients.