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

June 9, 2026 updated by: Gehad Mohamed Mohamdeen Ali Mohamed, Cairo University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

It is a three-armed, single-blind, parallel group randomized controlled trial. All patients who met the study's inclusion criteria were randomly allocated using a computerized randomization procedure to one of three groups with a 1:1:1 ratio. A blind researcher to the patient assignment evaluated the patient before and after the treatment procedures.

Sixty postmenopausal women with mild to moderate fibromyalgia were recruited from the rheumatology clinic at Al Kasr Al Ainy Hospital and the faculty of physical therapy outpatient clinic.

Patients were randomly allocated to three different groups: Group A received medical treatment in the form of pain relievers such as acetaminophen and antidepressants such as Duloxetine (Cymbalta) and milnacipran. Group (B) received the same medical treatment, in addition to CBT, for two sessions per week for 12 weeks. Group (C) received the same treatment as group (B) and low TENS three times per week for 12 weeks. There were no patient withdrawals throughout the study.

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).

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Non US Or Canada
      • Cairo, Non US Or Canada, Egypt
        • Faculty of Physical therapy outpatient clinics and Rheumatology clinic at Al Kasr Al Ainy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • female patients aged 50-60 years old
  • body mass index (BMI) between 25 and 29.9 kg/m2
  • patients meeting the 2016 American College of Rheumatology diagnostic criteria for fibromyalgia syndrome, including a widespread pain index (WPI) score of 7 or more, a symptom severity (SS) score of 5 or more, or a WPI score of 4 to 6 and an SS score of 9 or more.
  • Symptoms were present at a similar level for a minimum of 3 months.
  • No other condition accounts for the patient's pain

Exclusion Criteria:

  • had other rheumatologic, musculoskeletal, or neurological disorders or any diseases that cause cognitive abnormality or
  • had any contraindications to TENS.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group (A)
Group (A) received medical treatment in the form of pain relievers such as acetaminophen and antidepressants such as Duloxetine (Cymbalta) and milnacipran.
Drug: medical treatment
Type: Drug Name: Medical treatment (acetaminophen, duloxetine)
Other Names:
  • (acetaminophen, duloxetine)
Active Comparator: Group (B)
Group (B) received the same medical treatment, in addition to CBT, for two sessions per week for 12 weeks.
Drug: medical treatment
Type: Drug Name: Medical treatment (acetaminophen, duloxetine)
Other Names:
  • (acetaminophen, duloxetine)
Behavioral: Cognitive behavior therapy
Type: Behavioral Name: Cognitive Behavioral Therapy (CBT)
Other Names:
  • CBT
Experimental: Group (C)
Group (C) received the same treatment as group (B) and low TENS three times per week for 12 weeks.
Drug: medical treatment
Type: Drug Name: Medical treatment (acetaminophen, duloxetine)
Other Names:
  • (acetaminophen, duloxetine)
Behavioral: Cognitive behavior therapy
Type: Behavioral Name: Cognitive Behavioral Therapy (CBT)
Other Names:
  • CBT
Device: TENS
Name: Transcutaneous Electrical Nerve Stimulation (TENS). Type: device
Other Names:
  • Transcutaneous Electrical Nerve Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the pain distribution
Time Frame: 12 weeks
The Widespread Pain Index (WPI) is a self-report index measure that was used to assess bodily distribution of pain and to specifically quantify the degree of widespread body pain and assess for pain features (e.g., cognitive, emotional, and physical symptoms). The WPI assesses the presence of pain in 19 designated body locations over the past 7 days, such as the neck, right upper arm, left lower leg. Each location is equal to a score of 1.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom Severity Scale (SSI)
Time Frame: Baseline and after 12 weeks
A total SSS score ranged from 0 to 12, with each score ranging from zero to three. Zero indicated no problem, one indicated slight or mild problems, two indicated moderate problems, and three indicated severe problems .
Baseline and after 12 weeks
Assessment of pain threshold
Time Frame: Baseline and after 12 weeks
A pressure algometer was used to deliver pressure pain on a skin area of 1 cm2 between the thumb and index finger
Baseline and after 12 weeks
Assessment of heart rate variability (HRV)
Time Frame: Baseline and after 12 weeks
Electrocardiogram signal (ECG) (Philips Medical Systems, 3000 Minuteman Rd, Andover MA01810, USA). All signals were blindly analyzed. The acquisition of electrocardiogram signal (ECG) was performed immediately before and after the interventions for 10 minutes
Baseline and after 12 weeks
Assessment of fibromyalgia symptoms
Time Frame: Baseline and after 12 weeks
The questionnaire consists of 20 item that measure physical function like (feel good (1 item), missed work (1 item), do job (1 item), pain (1 item), fatigue (1 item), rested (1 item), stiffness (1 item), and cognitive function like (anxiety (1 item), and depression (1 item). Each patient in all groups was carefully instructed about the questionnaire.
Baseline and after 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Enas Abd Elazim, Dr., Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

January 30, 2025

Study Completion (Actual)

January 30, 2025

Study Registration Dates

First Submitted

April 10, 2026

First Submitted That Met QC Criteria

April 10, 2026

First Posted (Actual)

April 16, 2026

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/004339

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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