Effectiveness of a Multicomponent Treatment Based on Pain Neuroscience Education, Therapeutic Exercise, Cognitive Behavioral Therapy, and Mindfulness in Patients With Fibromyalgia (FIBROWALK Study): A Randomized Controlled Trial.
Study Goal
The researchers aimed to evaluate the effectiveness of a multicomponent treatment including mindfulness, compared to usual care, in improving functional impairment and other symptoms in fibromyalgia patients.
Results Summary
The multicomponent treatment showed significant improvements in functional impairment, pain, kinesiophobia, and physical function with large effect sizes, and moderate improvements in fatigue, anxiety, and depressive symptoms compared to usual care. Nonresponders had higher baseline depressive symptoms, and the number needed to treat was 2.
Population
272 patients with fibromyalgia.
Effective Dosage
2-hour weekly sessions (group-based, 20 participants per group).
Duration
12 weeks (with additional follow-up at 6 and 9 months for the multicomponent group only).
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
12-week multicomponent treatment based on pain neuroscience education, therapeutic exercise, cognitive behavioral therapy, and mindfulness | decrease | functional impairment | patients with fibromyalgia | Cohen d > 0.80 | significant between-group differences with a large effect size (Cohen d > 0.80) in favor of the multicomponent treatment were found | #1 |
12-week multicomponent treatment based on pain neuroscience education, therapeutic exercise, cognitive behavioral therapy, and mindfulness | decrease | pain | patients with fibromyalgia | Cohen d > 0.80 | significant between-group differences with a large effect size (Cohen d > 0.80) in favor of the multicomponent treatment were found | #2 |
12-week multicomponent treatment based on pain neuroscience education, therapeutic exercise, cognitive behavioral therapy, and mindfulness | decrease | kinesiophobia | patients with fibromyalgia | Cohen d > 0.80 | significant between-group differences with a large effect size (Cohen d > 0.80) in favor of the multicomponent treatment were found | #3 |
12-week multicomponent treatment based on pain neuroscience education, therapeutic exercise, cognitive behavioral therapy, and mindfulness | increase | physical function | patients with fibromyalgia | Cohen d > 0.80 | significant between-group differences with a large effect size (Cohen d > 0.80) in favor of the multicomponent treatment were found | #4 |
12-week multicomponent treatment based on pain neuroscience education, therapeutic exercise, cognitive behavioral therapy, and mindfulness | decrease | fatigue | patients with fibromyalgia | Cohen d > 0.50 and <0.80 | differences with a moderate size effect (Cohen d > 0.50 and <0.80) were found | #5 |
12-week multicomponent treatment based on pain neuroscience education, therapeutic exercise, cognitive behavioral therapy, and mindfulness | decrease | anxiety | patients with fibromyalgia | Cohen d > 0.50 and <0.80 | differences with a moderate size effect (Cohen d > 0.50 and <0.80) were found | #6 |
12-week multicomponent treatment based on pain neuroscience education, therapeutic exercise, cognitive behavioral therapy, and mindfulness | decrease | depressive symptoms | patients with fibromyalgia | Cohen d > 0.50 and <0.80 | differences with a moderate size effect (Cohen d > 0.50 and <0.80) were found | #7 |
12-week multicomponent treatment based on pain neuroscience education, therapeutic exercise, cognitive behavioral therapy, and mindfulness | increase | depressive symptoms | nonresponders (>20% Revised Fibromyalgia Impact Questionnaire reduction) | - | Nonresponders scored higher on depressive symptoms than responders at baseline | #8 |
12-week multicomponent treatment based on pain neuroscience education, therapeutic exercise, cognitive behavioral therapy, and mindfulness | neutral | treatment response | patients with fibromyalgia | 2 (95% CI = 1.7-2.3) | The number needed to treat was 2 | #9 |
12-week multicomponent treatment based on pain neuroscience education, therapeutic exercise, cognitive behavioral therapy, and mindfulness | decrease | fibromyalgia symptoms | patients with fibromyalgia | - | evidence of short-term (up to 3 months) positive effects | #10 |
multicomponent therapy FIBROWALK | neutral | fibromyalgia | patients with fibromyalgia | - | can be considered a novel and effective treatment | #11 |
multicomponent treatment | decrease | core symptoms of fibromyalgia | patients with fibromyalgia | - | could significantly improve the core symptoms of fibromyalgia | #12 |
OBJECTIVE: The purpose of this study was to evaluate the effectiveness of a 12-week multicomponent treatment based on pain neuroscience education, therapeutic exercise, cognitive behavioral therapy, and mindfulness-in addition to treatment as usual-compared with treatment as usual only in patients with fibromyalgia. METHODS: This randomized controlled trial involved a total of 272 patients who were randomly assigned to either multicomponent treatment (n = 135) or treatment as usual (n = 137). The multicomponent treatment (2-hour weekly sessions) was delivered in groups of 20 participants. Treatment as usual was mainly based on pharmacological treatment according to the predominant symptoms. Data on functional impairment using the Revised Fibromyalgia Impact Questionnaire as the primary outcome were collected as were data for pain, fatigue, kinesiophobia, physical function, anxiety, and depressive symptoms (secondary outcomes) at baseline, 12 weeks, and, for the multicomponent group only, 6 and 9 months. An intention-to-treat approach was used to analyze between-group differences. Baseline differences between responders (>20% Revised Fibromyalgia Impact Questionnaire reduction) and nonresponders also were analyzed, and the number needed to treat was computed. RESULTS: At posttreatment, significant between-group differences with a large effect size (Cohen d > 0.80) in favor of the multicomponent treatment were found in functional impairment, pain, kinesiophobia, and physical function, whereas differences with a moderate size effect (Cohen d > 0.50 and <0.80) were found in fatigue, anxiety, and depressive symptoms. Nonresponders scored higher on depressive symptoms than responders at baseline. The number needed to treat was 2 (95% CI = 1.7-2.3). CONCLUSION: Compared with usual care, there was evidence of short-term (up to 3 months) positive effects of the multicomponent treatment for fibromyalgia. Some methodological shortcomings (eg, absence of follow-up in the control group and monitoring of treatment adherence, potential research allegiance) preclude robust conclusions regarding the proposed multicomponent program. IMPACT: Despite some methodological shortcomings in the design of this study, the multicomponent therapy FIBROWALK can be considered a novel and effective treatment for patients with fibromyalgia. Physical therapists should detect patients with clinically relevant depression levels prior to treatment because depression can buffer treatment effects. LAY SUMMARY: Fibromyalgia is prevalent and can be expensive to treat. This multicomponent treatment could significantly improve the core symptoms of fibromyalgia compared with usual treatment.