CompletedNot Applicable

The Effect of Transcutaneous Posterior Tibial Nerve Stimulation in Patients With Fibromyalgia

Turkey (Türkiye)64 participantsStarted 2020-11-02

Plain-language summary

This study aimed to investigate the effectiveness of posterior tibial nerve stimulation (PTNS) in reducing pain, improving quality of life, and decreasing disease severity in patients with fibromyalgia.

Who can participate

Age range

18 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Female patients aged between 18 and 65 years, newly diagnosed according to the American Rheumatology Association 2016 revised FMS diagnostic criteria * Patients who come regularly to sessions for posterior tibial nerve stimulation. Exclusion Criteria: * History of fracture/musculoskeletal surgery in the last 3 years * Inflammatory joint disease, or neurological disease/neurological deficit with examination * Receiving medical treatment for polyneuropathy * Contraindications to PNS (pacemaker, epilepsy, diminished skin sensation in the area to be applied).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline in Numeric Rating Scale (NRS) of pain score at week 4 and 12

Timeframe: At baseline, 4th week and 12th week

Change from baseline in Short-Form McGill Pain Questionnaire at week 4 and 12

Timeframe: At baseline, 4th week and 12th week

Trial details

NCT IDNCT05937711

SponsorIlker Fatih Sari

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-23

View on ClinicalTrials.gov More Fibromyalgia trials