Dry Needling with Electrical Stimulation for Restless Legs Syndrome
This study is looking at how dry needling with electrical stimulation (DNES) might help people with Restless Legs Syndrome. DNES involves inserting thin needles into specific muscles, like those in your legs and hips, and then applying a mild electrical current. Researchers want to see if this treatment can improve your sleep quality, reduce the severity of your Restless Legs Syndrome symptoms, and help with your overall function. You may be able to join if you are between 18 and 75 years old and have a clinical diagnosis of Restless Legs Syndrome. The study will measure changes in your sleep, leg movements, and symptom severity over several weeks to see if the treatment is helpful. The current status of this study is unclear, and it plans to enroll 20 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 20 individuals.
- What's involved
- You would receive dry needling with electrical stimulation for a total of 2 sessions, once per week. You will also complete questionnaires at baseline, 4 weeks, and 8 weeks post-intervention, and weekly for 3 weeks for some measures.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your sleep quality and symptom severity will be measured at 4 and 8 weeks after the treatment. Periodic limb movement will be measured weekly for 3 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
The Effect of Dry Needling With Electrical Stimulation on Individuals With Restless Legs Syndrome
At a glance
Conditions
NCT05860751
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Mayo Clinic
Rochester, Minnesotastudy coordinator listed
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Ray Lunasin, PT, DPT, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
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Inclusion
Exclusion
What this trial measures
- Change in sleep qualityBaseline, 4 weeks and 8 weeks post-intervention
Measured using the Pittsburgh Sleep Quality Index (PSQI). Self-report questionnaire that measures general sleep quality. The scoring range is 0-21 with 0-3 scoring for each component. Higher scores indicate worse sleep quality.
- Change in periodic limb movementBaseline, weekly for 3 weeks
Measured using a consumer-grade sleep tracking device.
- Change in Restless Legs Syndrome symptom severityBaseline, 4 weeks and 8 weeks post-intervention
RLS symptom severity of each participant will be indexed with likert scale ratings and subacutely by completion of the International Restless Legs Syndrome Rating Scale (IRLSRS). The IRLSRS has demonstrated to be a valid and reliable outcome measure for RLS symptom severity. The scale consists of 10 questions concerning each patient's symptoms and the impact of those symptoms on daily activities and mood. Each question contains answers that score from 0 to 4 points, with 0 representing the absence of a problem and 4 representing a very severe problem. Total scores can range from 0 to 40 with higher scores indicating more severe symptoms.