drugset / Trial / NCT07533487

Adding Neuromodulation Technique to Cognitive Behavior Therapy on Fibromyalgia in Postmenopausal Women

NCT07533487

Completed 60 enrolled Cairo University
RandomizedParallel-groupSingle-blindTreatment

Summary

The goal of this clinical trial is to investigate the effect of adding transcutaneous electrical nerve stimulation to cognitive behavior therapy on fibromyalgia in postmenopausal women. The study aims to answer whether there would be an effect of adding TENS to cognitive behavior therapy (CBT) and medicines on pain, symptoms, HRV, and QOL in postmenopausal women with fibromyalgia The primary hypothesis is that there would be no effect of adding TENS to CBT and medicines on pain, symptoms, Heart rate variability (HRV), and quality of life (QOL) in postmenopausal women with fibromyalgia. Sixty postmenopausal women with mild to moderate fibromyalgia were allocated to 3 groups: Group A received medical treatment, Group B received medical treatment and CBT, and Group C received the same as B and low TENS. Pain was assessed using the widespread pain index (WPI) and pain pressure threshold (PPT). Fibromyalgia symptoms were evaluated using the symptoms severity index (SSI). Heart rate variability (HRV) and quality of life were assessed using the Fibromyalgia Impact Questionnaire (FIQ).

Timeline

Start
2022-09-01
Primary completion
2025-01-30
Completion
2025-01-30

Drugs

EvaluationDrugModalityDoseRoute
Background Acetaminophen Small molecule
Background Duloxetine Small molecule
Background Milnacipran Other / unclassified

Indications