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

NCT07533487 | Completed

• 1 other identifier: P.T.REC/012/004339
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Fibromyalgia; Cognitive behavioral therapy; TENS; pain; heart rate variability; quality of life

Outcome Measures

Primary Outcomes (1)

• Assessment of the pain distribution

  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 Outcomes (4)

• Symptom Severity Scale (SSI)

  Baseline and after 12 weeks

• Assessment of pain threshold

  Baseline and after 12 weeks

• Assessment of heart rate variability (HRV)

  Baseline and after 12 weeks

• Assessment of fibromyalgia symptoms

  Baseline and after 12 weeks

Study Arms (3)

Group (A)

ACTIVE COMPARATOR

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

Group (B)

ACTIVE COMPARATOR

Group (B) received the same medical treatment, in addition to CBT, for two sessions per week for 12 weeks.

Behavioral: Cognitive behavior therapy; Drug: medical treatment

Group (C)

EXPERIMENTAL

Group (C) received the same treatment as group (B) and low TENS three times per week for 12 weeks.

Device: TENS; Behavioral: Cognitive behavior therapy; Drug: medical treatment

Interventions

TENS DEVICE

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

Also known as: Transcutaneous Electrical Nerve Stimulation

Group (C)

Cognitive behavior therapy BEHAVIORAL

Type: Behavioral Name: Cognitive Behavioral Therapy (CBT)

Also known as: CBT

Group (B); Group (C)

medical treatment DRUG

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

Also known as: (acetaminophen, duloxetine)

Group (A); Group (B); Group (C)

Eligibility Criteria

• Age: 50 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• female patients aged 50-60 years old; (2) their body mass index (BMI) between 25 to 29.9 kg/m2; (3) 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

You may not qualify if:

• Patients were not eligible to participate if they had other rheumatologic, musculoskeletal, or neurological disorders or any diseases that cause cognitive abnormality or had any contraindications to TENS.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

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

Cairo, Non US Or Canada, Egypt

Location

MeSH Terms

Conditions

Fibromyalgia; Pain

Interventions

Transcutaneous Electric Nerve Stimulation; Cognitive Behavioral Therapy; Acetaminophen; Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Thiophenes; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Enas Abd Elazim, Dr.

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: 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.

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 16, 2026
• Study Start: September 1, 2022
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

EG (1)