NCT07533487

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: 50 Years – 60 Years
• Healthy volunteers: Not accepted

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).

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).

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2022-09-01
• Primary completion: 2025-01-30
• Completion: 2025-01-30
• First posted: 2026-04-16
• Last updated: 2026-04-16

Locations

1 site across 1 country: Egypt