Electromyogram-Biofeedback in Patients with Fibromyalgia A Randomized Controlled Trial

Electromyogram-Biofeedback in Patients with Fibromyalgia: A
Randomized Controlled Trial Objective: To evaluate the
effectiveness of EMG-biofeedback in patients with Fibromyalgia.
Design: The study design was a randomized controlled pilot trial
with blinded assessors and three points of assessment: before
intervention (baseline, T0), at the end of treatment (T1) and a
3-months follow-up (T2). Setting: Outpatient clinic. Patients:
Patients from the waiting list of the Fibromyalgia day hospital
program fulfilling the inclusion criteria. Intervention: During
eight weeks, 14 sessions of EMG-biofeedback training versus usual
care only. Outcome Measures and Analysis: For primary outcome, the
disease specific health status was followed using the Fibromyalgia
Impact Questionnaire (FIQ). Secondary outcome measures comprise
assessment of pain (Tender Point Score), tenderness (Tender Point
Count = number of Tender Points, Pain Pressure Threshold), generic
health status (SF-36), Patients’ Global Clinical Impression of
Change and psychic impact (Beck depression Inventory, Symptom
Checklist 90-Revised). Effects were analyzed with sensitivity
statistics (effect size, ES), parametric and nonparametric tests.
Results: The data of 36 patients with complete follow-up data could
be analyzed. EMG-EMG-biofeedback did not improve health status of
patients with Fibromyalgia (FIQ, T1: ES = 0.02, p = 0.95, T2: ES =
0.26, p = 0.43). Also, the secondary outcome measures, with the
exception of the pressure pain threshold (T1: ES = 0.26, p =
0.014), showed no superiority of EMG-biofeedback in addition to
usual care compared to usual care alone. Conclusion: In the
treatment of patients with Fibromyalgia, EMG-biofeedback training
in addition to usual medical care is not superior to usual medical
care alone.