New combo therapy shows promise for fibromyalgia in menopause
NCT ID NCT07533487
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether adding a gentle electrical nerve stimulation (TENS) to cognitive behavior therapy (CBT) and standard medicines could reduce pain and improve quality of life in 60 postmenopausal women with fibromyalgia. Participants were split into three groups: one received only medication, another added CBT, and the third added both CBT and TENS. The goal was to see if the combined approach offered extra relief for pain, symptoms, and daily function.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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60 people
The number who actually took part.
- Started
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Sep 2022
- Finished
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Jan 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 60 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Faculty of Physical therapy outpatient clinics and Rheumatology clinic at Al Kasr Al Ainy Hospital
Cairo, Non US Or Canada, Egypt
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Other studies related to the condition(s) this trial covers.
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