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COMPLETED
NCT07533487
NA

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

Sponsor: Cairo University

View on ClinicalTrials.gov

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).

Official title: Effect of Adding Neuromodulation Technique to Cognitive Behavior Therapy on Fibromyalgia in Postmenopausal Women

Key Details

Gender

FEMALE

Age Range

50 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2022-09-01

Completion Date

2025-01-30

Last Updated

2026-06-10

Healthy Volunteers

No

Conditions

Interventions

DEVICE

TENS

Name: Transcutaneous Electrical Nerve Stimulation (TENS). Type: device

BEHAVIORAL

Cognitive behavior therapy

Type: Behavioral Name: Cognitive Behavioral Therapy (CBT)

DRUG

medical treatment

Type: Drug Name: Medical treatment (acetaminophen, duloxetine)

Locations (1)

Faculty of Physical therapy outpatient clinics and Rheumatology clinic at Al Kasr Al Ainy Hospital

Cairo, Non US Or Canada, Egypt