Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-31 @ 6:24 AM
Study NCT ID:
NCT04609735
Status:
RECRUITING
Last Update Posted:
2025-05-18
First Post:
2020-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Manual Therapy, Exercise and US Vs. Manual Therapy, Exercise and US for Medial Epicondylalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2020-10-26', 'studyFirstSubmitQcDate': '2020-10-26', 'lastUpdatePostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in elbow pain intensity (NPRS)', 'timeFrame': 'Baseline, 1-week, 4-weeks, 3-months', 'description': 'Numeric Pain Rating Score. Higher scores mean greater pain'}], 'secondaryOutcomes': [{'measure': 'Disabilities of the Arm, Shoulder and Hand', 'timeFrame': 'Baseline, 1-week, 4-weeks, 3-months', 'description': 'The DASH is measured on a 0-100 scale. Greater scores indicate increased disability.'}, {'measure': 'Change in Global rating of change score', 'timeFrame': '4-weeks, 3-months', 'description': 'Global rating of change - Scale = -7 to 7. Greater numbers represent a perceived improvement of symptoms, while lesser scores indicate a perceived worsening of symptoms'}, {'measure': 'Change in Medication Intake (Frequency of Medication Intake in last week)', 'timeFrame': 'Baseline, 3-months', 'description': 'Frequency of medication intake in last week'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epicondylalgia']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to compare two different approaches for treating patients with medial epicondylalgia: manual therapy, exercise and ultrasound and manual therapy, exercise, ultrasound and electric dry needling. Physical therapists commonly use all of these techniques to treat medial epicondylalgia. This study is attempting to find out if one treatment strategy is more effective than the other.', 'detailedDescription': 'Patients with medial epicondylalgia will be randomized to receive 8 treatments (2 treatments per week) over 4 weeks (8 treatments max) of either: 1. manual therapy, exercise and ultrasound or 2. manual therapy, exercise, ultrasound and electric dry needling'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult between18 and 60 years old that is able to speak English.\n2. Report of at least 6 weeks of elbow (i.e. medial epicondyle) and ventral forearm pain, consistent with medial epicondylalgia.\n3. Patient has not had physical therapy, massage therapy, chiropractic treatment or injections for elbow pain in the last 6 months.\n4. Diagnosis of medial epicondylalgia, defined as the following:(Walz, 2010; Shin, 2019)\n\n 1. Tenderness is elicited by palpation of the insertion of the flexor-pronator mass (5-10 mm distal and anterior to the middle aspect of the medial epicondyle)\n 2. Pain is exacerbated by resisted wrist flexion and forearm pronation at an angle of 90°\n\nExclusion Criteria:\n\n1. Report of red flags to manual physical therapy to include: severe hypertension, infection, uncontrolled diabetes, peripheral neuropathy, heart disease, stroke, chronic ischemia, edema, severe varicosities, tumor, metabolic disease, prolonged steroid use, fracture, RA, osteoporosis, severe vascular disease, malignancy, etc.\n2. Report of Previous surgery of the elbow, history of elbow dislocation, elbow fracture and/or tendon rupture.\n3. History of or presentation consistent with osteochondritis dissecans, osteoarthrosis, MCL injury (i.e. Pain with valgus stress or positive "milking test" - pulling on the thumb with the elbow in flexion and the forearm in supination), flexor-pronator strain, and ulnar neuropathy (i.e. Positive Tinel sign - distal pain and tingling during direct compression of the nerve at the elbow).\n4. Report of systemic neurological disorders and/or neurological deficits to include the following: a. Nerve root compression (muscle weakness involving a major muscle group of the upper extremity, diminished upper extremity deep tendon reflex, or diminished or absent sensation to pinprick in any upper extremity dermatome) b. Cervical or thoracic spinal stenosis (exhibited by bilateral upper extremity symptoms) c. Central nervous system involvement (hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes) d. History of whiplash or T-spine injury injury within the previous 6 weeks 5. History of surgery to the head/neck/T-spine or affected upper extremity.\n\n6\\. Psychiatric disorders or cognitively impaired 7. Pregnancy'}, 'identificationModule': {'nctId': 'NCT04609735', 'briefTitle': 'Manual Therapy, Exercise and US Vs. Manual Therapy, Exercise and US for Medial Epicondylalgia', 'organization': {'class': 'OTHER', 'fullName': 'Alabama Physical Therapy & Acupuncture'}, 'officialTitle': 'Manual Therapy, Exercise and Ultrasound Vs. Manual Therapy, Exercise, Ultrasound and Electric Dry Needling for Patients With Medial Epicondylalgia', 'orgStudyIdInfo': {'id': 'AAMT50'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Electric DN, Manual therapy, exercise and US', 'description': 'Dry needling, manual therapy, exercise and ultrasound', 'interventionNames': ['Other: Electric Dry Needling, Manual Therapy, Exercise and Ultrasound']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active comparator: Manual therapy, exercise and ultrasound', 'description': 'Active comparator: Manual therapy, exercise and ultrasound', 'interventionNames': ['Other: Manual Therapy, Exercise and Ultrasound']}], 'interventions': [{'name': 'Electric Dry Needling, Manual Therapy, Exercise and Ultrasound', 'type': 'OTHER', 'description': 'Electric Dry Needling, Manual Therapy, Exercise and Ultrasound', 'armGroupLabels': ['Experimental: Electric DN, Manual therapy, exercise and US']}, {'name': 'Manual Therapy, Exercise and Ultrasound', 'type': 'OTHER', 'description': 'Electric Dry Needling, Manual Therapy, Exercise and Ultrasound vs. Manual Therapy, Exercise and Ultrasound', 'armGroupLabels': ['Active comparator: Manual therapy, exercise and ultrasound']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46804', 'city': 'Fort Wayne', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ben England, DPT', 'role': 'CONTACT', 'email': 'benjaminengland1313@gmail.com', 'phone': '740-403-9133'}], 'facility': 'Mallers and Swoverland Orthopedic PT', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}], 'centralContacts': [{'name': 'James Dunning, DPT PhD', 'role': 'CONTACT', 'email': 'jamesdunning@hotmail.com', 'phone': '801-707-9056'}, {'name': 'Raymond J Butts, DPT PhD', 'role': 'CONTACT', 'email': 'fellowship@spinalmanipulation.org', 'phone': '803-422-3954'}], 'overallOfficials': [{'name': 'James Dunning, DPT PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'American Academy of Manipulative Therapy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alabama Physical Therapy & Acupuncture', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidad Rey Juan Carlos', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, American Academy of Manipulative Therapy', 'investigatorFullName': 'James Dunning, DPT, MSc, FAAOMPT', 'investigatorAffiliation': 'Alabama Physical Therapy & Acupuncture'}}}}