The Effect of Dry Needling With Electrical Stimulation on Individuals With Restless Legs Syndrome (NCT05860751) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Effect of Dry Needling With Electrical Stimulation on Individuals With Restless Legs Syndrome
United States20 participantsStarted 2027-02
Plain-language summary
The purpose of this study is to examine the effects of dry needling with electrical stimulation (DNES) on sleep quality, symptom severity, and function in individuals with restless legs syndrome.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
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:
* Age 18-75 years
* Clinical diagnosis of restless legs syndrome
Exclusion Criteria:
* Active cancer diagnoses
* Neuropathic pain (e.g., lumbosacral radiculopathy and/or diabetic neuropathy),
* Pregnancy
* Immunocompromised disease (e.g., HIV, AIDS, lupus)
* Insufficient English-language skills to complete all questionnaires
* Inability to maintain treatment positions
* Contraindications to dry needling:35,36
* Presence of needle phobia
* History of abnormal reaction to needling or injection
* History of bleeding disorder
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
1
Change in sleep quality
Timeframe: Baseline, 4 weeks and 8 weeks post-intervention
2
Change in periodic limb movement
Timeframe: Baseline, weekly for 3 weeks
3
Change in Restless Legs Syndrome symptom severity
Timeframe: Baseline, 4 weeks and 8 weeks post-intervention