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Completed
NCT07533487
Adding Neuromodulation Technique to Cognitive Behavior Therapy on Fibromyalgia in Postmenopausal Women
Conditions: Fibromyalgia
Sex: Female
Ages: 50 Years – 60 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Cairo University
Location: Faculty of Physical therapy outpatient clinics and Rheumatology clinic at Al Kasr Al Ainy Hospital Cairo Non US Or Canada
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).
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07533487). StuddyBuddy aggregates publicly available trial information.