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NCT Number: NCT05860751

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.

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Key information

Conditions

Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dry Needling with electrical stimulation

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.

Primary outcomes

  1. Change in sleep quality

    Time frame: Baseline, 4 weeks and 8 weeks post-intervention

    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.

  2. Change in periodic limb movement

    Time frame: Baseline, weekly for 3 weeks

    Measured using a consumer-grade sleep tracking device.

  3. Change in Restless Legs Syndrome symptom severity

    Time frame: Baseline, 4 weeks and 8 weeks post-intervention

    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.

Secondary outcomes

  1. Change in pain level

    Time frame: Baseline, 4 weeks and 8 weeks post-intervention

    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."

  2. Change in quality of life

    Time frame: Baseline, 4 weeks and 8 weeks post-intervention

    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.

  3. Acute change in Restless Legs Syndrome symptoms

    Time frame: Baseline, Immediately post-intervention

    Likert Scale

Study contacts

Contact information is provided by the study sponsor or research team.

Ray Lunasin, PT, DPT, PhD

CONTACT

[email protected]

5075380839

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
May 16, 2023
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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