NCT05860751

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Feb 2027

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 16, 2023

Completed
3.7 years until next milestone

Study Start

First participant enrolled

February 1, 2027

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

May 8, 2023

Last Update Submit

March 12, 2026

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Change in pain level

    Baseline, 4 weeks and 8 weeks post-intervention

  • Change in quality of life

    Baseline, 4 weeks and 8 weeks post-intervention

  • Acute change in Restless Legs Syndrome symptoms

    Baseline, Immediately post-intervention

Study Arms (1)

Dry needling with electrical stimulation

EXPERIMENTAL

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

Procedure: Dry Needling with electrical stimulation

Interventions

Dry Needling with electrical stimulationPROCEDURE

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.

Dry needling with electrical stimulation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-75 years
  • Clinical diagnosis of restless legs syndrome

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Dry NeedlingElectric Stimulation

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesPhysical StimulationInvestigative Techniques

Study Officials

  • Ray Lunasin, PT, DPT, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ray Lunasin, PT, DPT, PhD

CONTACT

5075380839lunasin.ray@mayo.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 8, 2023

First Posted

May 16, 2023

Study Start (Estimated)

February 1, 2027

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)