The Effect of Dry Needling With Electrical Stimulation on Individuals With Restless Legs Syndrome

NCT ID: NCT05860751

Last Updated: 2025-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Neck Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dry needling with electrical stimulation

Participants with restless legs syndrome will receive dry needling with electrical stimulation to the lower extremities

Group Type EXPERIMENTAL

Dry Needling with electrical stimulation

Intervention Type PROCEDURE

Administered for a total of 2 sessions at a frequency of once per week. The target muscles to be needled will include the gastronemius, soleus, vastus lateralis, rectus femoris, anterior tibialis, posterior tibialis, biceps femoris, and gluteus medius.

Interventions

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Dry Needling with electrical stimulation

Administered for a total of 2 sessions at a frequency of once per week. The target muscles to be needled will include the gastronemius, soleus, vastus lateralis, rectus femoris, anterior tibialis, posterior tibialis, biceps femoris, and gluteus medius.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Ray M. Lunasin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ray Lunasin, PT, DPT, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Central Contacts

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Ray Lunasin, PT, DPT, PhD

Role: CONTACT

5075380839

Facility Contacts

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Ray Lunasin

Role: primary

507-538-0839

Other Identifiers

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22-009645

Identifier Type: -

Identifier Source: org_study_id

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