The Effect of Dry Needling with Electrical Stimulation on Individuals with Restless Legs Syndrome
- Conditions
- Neck Pain
- Interventions
- Procedure: Dry Needling with electrical stimulation
- Registration Number
- NCT05860751
- Lead Sponsor
- Mayo Clinic
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20
- Age 18-75 years
- Clinical diagnosis of restless legs syndrome
-
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dry needling with electrical stimulation Dry Needling with electrical stimulation Participants with restless legs syndrome will receive dry needling with electrical stimulation to the lower extremities
- Primary Outcome Measures
Name Time Method Change in periodic limb movement Baseline, weekly for 3 weeks Measured using a consumer-grade sleep tracking device.
Change in Restless Legs Syndrome symptom severity 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.
Change in sleep quality 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.
- Secondary Outcome Measures
Name Time Method Change in quality of life 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.
Change in pain level 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."
Acute change in Restless Legs Syndrome symptoms Baseline, Immediately post-intervention Likert Scale
Trial Locations
- Locations (1)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States