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

N/ANot Yet RecruitingNCT05860751

Mayo Clinic20 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neck Pain

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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.

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

Change in periodic limb movement

Measured using a consumer-grade sleep tracking device.

Time frame: 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.

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

Secondary Outcomes

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."

Time frame: 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.

Central Contacts

Ray Lunasin, PT, DPT, PhD

CONTACT

5075380839 lunasin.ray@mayo.edu

Data from ClinicalTrials.gov

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