Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-03-06 @ 9:37 AM
Study NCT ID:
NCT02331069
Status:
UNKNOWN
Last Update Posted:
2015-03-17
First Post:
2014-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Delto-Tricipital Compression Syndrome: Treated With Injection of Dextrose
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020425', 'term': 'Radial Neuropathy'}], 'ancestors': [{'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005947', 'term': 'Glucose'}, {'id': 'D014867', 'term': 'Water'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-13', 'studyFirstSubmitDate': '2014-12-17', 'studyFirstSubmitQcDate': '2015-01-01', 'lastUpdatePostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NRS Pain (0-10 Numerical Rating Scale)', 'timeFrame': 'Time 0 and 1 month', 'description': '0-10 Numerical Rating Scale for pain.'}], 'secondaryOutcomes': [{'measure': 'Quick Dash Score', 'timeFrame': 'Time 0 and 1 month', 'description': 'Validated shortened version of Disabilities of Arm Shoulder and Hand score.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['radial neuropathy'], 'conditions': ['Superficial Radial Nerve Lesion']}, 'referencesModule': {'references': [{'pmid': '23481405', 'type': 'BACKGROUND', 'citation': 'Sorensen AA, Howard D, Tan WH, Ketchersid J, Calfee RP. Minimal clinically important differences of 3 patient-rated outcomes instruments. J Hand Surg Am. 2013 Apr;38(4):641-9. doi: 10.1016/j.jhsa.2012.12.032. Epub 2013 Mar 6.'}, {'pmid': '23850615', 'type': 'RESULT', 'citation': 'Rabago D, Kijowski R, Woods M, Patterson JJ, Mundt M, Zgierska A, Grettie J, Lyftogt J, Fortney L. Association between disease-specific quality of life and magnetic resonance imaging outcomes in a clinical trial of prolotherapy for knee osteoarthritis. Arch Phys Med Rehabil. 2013 Nov;94(11):2075-82. doi: 10.1016/j.apmr.2013.06.025. Epub 2013 Jul 10.'}, {'pmid': '19549615', 'type': 'RESULT', 'citation': 'Yelland MJ, Sweeting KR, Lyftogt JA, Ng SK, Scuffham PA, Evans KA. Prolotherapy injections and eccentric loading exercises for painful Achilles tendinosis: a randomised trial. Br J Sports Med. 2011 Apr;45(5):421-8. doi: 10.1136/bjsm.2009.057968. Epub 2009 Jun 22.'}]}, 'descriptionModule': {'briefSummary': 'The posterior antebrachial cutaneous nerve (PACN) can be compressed between the deltoid and triceps, with resultant pain and dysfunction. The active treatment for this study will be injection of the point of compression and along the painful course of the sensory nerve with 5% dextrose. The control treatment will be physical therapy.', 'detailedDescription': 'The PACN is a purely sensory nerve that originates in the midforearm, courses anterior to the lateral epicondyle, and travels proximally until it dives between the posterior portion of the V shaped insertion of the deltoid and the external? insertion of the triceps, whereupon it joins with the radial nerve.\n\nA proposed pathological explanation is that repetitive co-contraction produces irritation and compression of the nerve at the delto-tricipital (D-T) fascial penetration point. Clinically the patient experiences pain localized to that compression point, and traveling distally along the course of some or all of the posterior femoral cutaneous nerve.\n\nPerineural injection of dextrose has been previously reported for therapeutic use in chronic pain associated with Achilles tendinopathy. Empirically,injection of D5W with a small needle along the course of the PACN and at the D-T penetrator has been found to resolve both pain and dysfunction (describe dysfunction).\n\nParticipants will be randomly assigned to either 1 month of physical therapy or to 0,1,2 and 3 week injection of D5W. The use of standardized measurement tools for pain (0-10 numerical rating scale) and function (Quick DASH) will be utilized to determine baseline status and status at 1 month. At 1 month, subjects receiving therapy will be allowed to cross over to injection treatment and all participants will receive as needed treatment until the 1 year period of follow-up. Thus only 1 month data is randomized but long term data will be gathered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pain in the deltotricipital groove,extending down the lateral septum.\n2. Pain rating 6 or more on a 0-10 numerical rating scale (NRS)\n3. Reproduction of pain with provocative maneuvers. Lifting a 6 pound weight to 60 degrees with the below at 40 degrees of elbow extension and the clinician creating a flexion force on the elbow which the participant resists. (Need a picture)\n4. Pain more than 3 months?\n\nExclusion Criteria:\n\n1. Pain in other arm or shoulder locations on either side more than 2/10\n2. Pain in other part of the body more than 4/10.\n3. Taking narcotics for pain.\n4. Pain with testing of shoulder laxity.\n5. Massive rupture of rotator cuff (complete width tear) evidenced by examination or MRI scan.\n6. Level III-IV or more shoulder arthritis on plain film of shoulder.\n7. Other peripheral neuropathy.\n8. Unstable psychiatric status'}, 'identificationModule': {'nctId': 'NCT02331069', 'briefTitle': 'Delto-Tricipital Compression Syndrome: Treated With Injection of Dextrose', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Abierta Interamericana'}, 'officialTitle': 'Delto-Tricipital Compression Syndrome: A Randomized Treatment Comparison Trial of Dextrose Injection Versus Physical Therapy.', 'orgStudyIdInfo': {'id': 'UAI Protocol number 01006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dextrose 5% (D5W) Injection', 'description': 'Glucose injection in 5% concentration, administered weekly X 4 times in a volume of 12 ml or less.', 'interventionNames': ['Drug: Dextrose 5% (D5W)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Physical Therapy', 'description': 'Physical therapy for a month in the posterior deltoid region 3 times a week.', 'interventionNames': ['Other: Physical therapy']}], 'interventions': [{'name': 'Dextrose 5% (D5W)', 'type': 'DRUG', 'otherNames': ['glucose 5% in water'], 'description': '0,1,2, and 3 week injection sessions consisting of injection of 2 ml of D5W into the D-T groove at the point of maximal pain at 1-2 cm depth, followed by subcutaneous injection of D5W at 4 cm intervals along the course of the PACN if tenderness is present.', 'armGroupLabels': ['Dextrose 5% (D5W) Injection']}, {'name': 'Physical therapy', 'type': 'OTHER', 'description': 'Three times weekly X 3 week sessions to include myofascial release, exercise, and one modality.', 'armGroupLabels': ['Physical Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2000', 'city': 'Rosario', 'state': 'Santa Fe Province', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Ezequiel Mailand, MD', 'role': 'CONTACT', 'email': 'ezmailand@gmail.com', 'phone': '0054 341 6393318'}, {'name': 'Daniel Mailand, MD', 'role': 'CONTACT', 'email': 'dmailand@gmail.com', 'phone': '0054 341 6393339'}], 'facility': 'Clinica Scanner', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': '2000', 'city': 'Rosario', 'state': 'Santa Fe Province', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'MigueL Slullitel, PHD', 'role': 'CONTACT', 'email': 'mslullitel@gmail.com', 'phone': '0054 341 5012223'}, {'name': 'Ezequiel Mailand, MD', 'role': 'CONTACT', 'email': 'ezmailand@gmail.com', 'phone': '0054 314 6393318'}, {'name': 'Miguel H Slullitel, Phd', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ezequiel Mailand, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Instituto Jaime Slullitel', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}], 'centralContacts': [{'name': 'Miguel Slullitel, PHD', 'role': 'CONTACT', 'email': 'mslullitel@gmail.com', 'phone': '00543415012223'}, {'name': 'Ezequiel Mailand, MD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Mailand Ezequiel, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Non affiliated'}, {'name': 'Dean Reeves', 'role': 'STUDY_CHAIR', 'affiliation': 'Non Affiliated'}, {'name': 'David Rabago', 'role': 'STUDY_CHAIR', 'affiliation': 'Non affiliated'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Abierta Interamericana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Orthopedic Surgery', 'investigatorFullName': 'Miguel Slullitel', 'investigatorAffiliation': 'Universidad Abierta Interamericana'}}}}