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 range18 Years – 75 Years

SexALL

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

What they're measuring

Change in sleep quality

Timeframe: Baseline, 4 weeks and 8 weeks post-intervention

Change in periodic limb movement

Timeframe: Baseline, weekly for 3 weeks

Change in Restless Legs Syndrome symptom severity

Timeframe: Baseline, 4 weeks and 8 weeks post-intervention

Trial details

NCT IDNCT05860751

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08

Contact for this trial

Ray Lunasin, PT, DPT, PhD

5075380839 lunasin.ray@mayo.edu

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