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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neck Pain
• Intervention / Treatment: Procedure: Dry Needling with electrical stimulation

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ray Lunasin, PT, DPT, PhD; Phone Number: 5075380839; Email: lunasin.ray@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
      • Contact: Ray Lunasin; Phone Number: 507-538-0839; Email: lunasin.ray@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dry needling with electrical stimulation; Participants with restless legs syndrome will receive dry needling with electrical stimulation to the lower extremities	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in sleep quality	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.	Baseline, 4 weeks and 8 weeks post-intervention
Change in periodic limb movement	Measured using a consumer-grade sleep tracking device.	Baseline, weekly for 3 weeks
Change in Restless Legs Syndrome symptom severity	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.	Baseline, 4 weeks and 8 weeks post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain level	Measured using the Numerical Pain Rating Scale (NPRS), an 11-point numeric scale ranging from '0' representing "no pain" to '10' representing "worst pain imaginable."	Baseline, 4 weeks and 8 weeks post-intervention
Change in quality of life	Quality of life will be measured using the EuroQol (EQ-5D-5L), a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each level is rated on a scale that describes the degree of problems in that area. This tool also has an overall health scale where the rater selects a number between 1-100 to describe the condition of their health, 100 being the best imaginable. The EuroQol has been identified as a valid and reliable outcome measurement for quality of life.	Baseline, 4 weeks and 8 weeks post-intervention
Acute change in Restless Legs Syndrome symptoms	Likert Scale	Baseline, Immediately post-intervention

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Ray Lunasin, PT, DPT, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: May 8, 2023
• First Submitted That Met QC Criteria: May 8, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neck Pain; Investigative Techniques; Therapeutics; Complementary Therapies; Physical Therapy Modalities; Physical Stimulation; Dry Needling; Electric Stimulation
• Other Study ID Numbers: 22-009645

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No