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

NCT07533487 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-16

No results posted yet for this study

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).

Conditions

  • Fibromyalgia

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)

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Enas Abd Elazim, Dr. · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07533487 on ClinicalTrials.gov