Skip to main content
OpenTrials
Completed

NCT Number: NCT07533487

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

50 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Cairo, Non US Or Canada, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TENS

Device

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

Other names: Transcutaneous Electrical Nerve Stimulation

Cognitive Behavior Therapy

Behavioral

Type: Behavioral Name: Cognitive Behavioral Therapy (CBT)

Other names: CBT

medical treatment

Drug

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

Other names: (acetaminophen, duloxetine)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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 .

  2. 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

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 16, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.