Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT05860751
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-10
First Post:
2023-05-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Dry Needling With Electrical Stimulation on Individuals With Restless Legs Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000079245', 'term': 'Dry Needling'}, {'id': 'D004558', 'term': 'Electric Stimulation'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D010812', 'term': 'Physical Stimulation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-06', 'studyFirstSubmitDate': '2023-05-08', 'studyFirstSubmitQcDate': '2023-05-08', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in sleep quality', 'timeFrame': 'Baseline, 4 weeks and 8 weeks post-intervention', 'description': '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.'}, {'measure': 'Change in periodic limb movement', 'timeFrame': 'Baseline, weekly for 3 weeks', 'description': 'Measured using a consumer-grade sleep tracking device.'}, {'measure': 'Change in Restless Legs Syndrome symptom severity', 'timeFrame': 'Baseline, 4 weeks and 8 weeks post-intervention', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Change in pain level', 'timeFrame': 'Baseline, 4 weeks and 8 weeks post-intervention', 'description': '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."'}, {'measure': 'Change in quality of life', 'timeFrame': 'Baseline, 4 weeks and 8 weeks post-intervention', 'description': '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.'}, {'measure': 'Acute change in Restless Legs Syndrome symptoms', 'timeFrame': 'Baseline, Immediately post-intervention', 'description': 'Likert Scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neck Pain']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-75 years\n* Clinical diagnosis of restless legs syndrome\n\nExclusion Criteria:\n\n* Active cancer diagnoses\n* Neuropathic pain (e.g., lumbosacral radiculopathy and/or diabetic neuropathy),\n* Pregnancy\n* Immunocompromised disease (e.g., HIV, AIDS, lupus)\n* Insufficient English-language skills to complete all questionnaires\n* Inability to maintain treatment positions\n* Contraindications to dry needling:35,36\n\n * Presence of needle phobia\n * History of abnormal reaction to needling or injection\n * History of bleeding disorder'}, 'identificationModule': {'nctId': 'NCT05860751', 'briefTitle': 'The Effect of Dry Needling With Electrical Stimulation on Individuals With Restless Legs Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'The Effect of Dry Needling With Electrical Stimulation on Individuals With Restless Legs Syndrome', 'orgStudyIdInfo': {'id': '22-009645'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dry needling with electrical stimulation', 'description': 'Participants with restless legs syndrome will receive dry needling with electrical stimulation to the lower extremities', 'interventionNames': ['Procedure: Dry Needling with electrical stimulation']}], 'interventions': [{'name': 'Dry Needling with electrical stimulation', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Dry needling with electrical stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'contacts': [{'name': 'Ray Lunasin', 'role': 'CONTACT', 'email': 'lunasin.ray@mayo.edu', 'phone': '507-538-0839'}], 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'Ray Lunasin, PT, DPT, PhD', 'role': 'CONTACT', 'email': 'lunasin.ray@mayo.edu', 'phone': '5075380839'}], 'overallOfficials': [{'name': 'Ray Lunasin, PT, DPT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ray M. Lunasin', 'investigatorAffiliation': 'Mayo Clinic'}}}}