Menu
Not yet recruiting NCT05860751

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

No phase Interventional Neck Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dry Needling with electrical stimulation.
Who it may be relevant to
Registry conditions: Neck Pain. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Change in sleep quality [Time frame: Baseline, 4 weeks and 8 weeks post-intervention]
  • Change in periodic limb movement [Time frame: Baseline, weekly for 3 weeks]
  • Change in Restless Legs Syndrome symptom severity [Time frame: Baseline, 4 weeks and 8 weeks post-intervention]
Secondary outcome measures (3)
  • Change in pain level [Time frame: Baseline, 4 weeks and 8 weeks post-intervention]
  • Change in quality of life [Time frame: Baseline, 4 weeks and 8 weeks post-intervention]
  • Acute change in Restless Legs Syndrome symptoms [Time frame: Baseline, Immediately post-intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic — Rochester

Identifiers

NCT: NCT05860751 · 22-009645

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗