Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 4:41 AM
Study NCT ID:
NCT07432750
Status:
RECRUITING
Last Update Posted:
2026-02-25
First Post:
2026-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Efficacy of Osteopathic Manipulation vs. Wrist Immobilization for Carpal Tunnel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}], 'ancestors': [{'id': 'D020423', 'term': 'Median Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026301', 'term': 'Manipulation, Osteopathic'}], 'ancestors': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'One group will receive Osteopathic Manipulative Treatment and one group will receive the standard of care (wrist immobilization splints).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-18', 'studyFirstSubmitDate': '2026-02-11', 'studyFirstSubmitQcDate': '2026-02-18', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Magnetic Resonance Imaging', 'timeFrame': '6 weeks', 'description': "Objective measures will be in the form of the cross sectional area of the patient's affected carpal tunnel obtained through magnetic resonance imaging. Measurement of the carpal tunnel, obtained by measuring the distance between the transverse carpal ligament and the floor of the tunnel will be obtained.\n\nTransverse measurements of the carpal tunnel will be obtained as well. From these measurements, the volume of the carpal tunnel will be determined. Increased carpal tunnel cross sectional area following treatment, whether due to bracing or osteopathic manipulative treatment, will indicate decreased compression of the median nerve and will likely be correlated to improved subjective measures. Statistical analysis of the cross sectional area of the carpal tunnel for each subject will be completed using the Wilcoxon signed-rank test. Statistical analysis comparing the efficacies of bracing and osteopathic manipulative treatment will be completed using Mann-Whitney U test."}], 'secondaryOutcomes': [{'measure': 'Boston Carpal Tunnel Questionnaire', 'timeFrame': '10 weeks', 'description': 'The questionnaire will be administered 4 different times: before treatment, 3 weeks into treatment, at the end of treatment, and 1 month after treatment is completed. Decreased scores on the Boston Carpal Questionnaire will indicate improved quality of life and functionality of the subjects\n\nThe questionnaire is split into two parts. Part 1 assesses symptom severity on a scale from 1 (normal) to 5 (very serious). Some items questioned include severity of hand or wrist pain at night, severity of hand weakness or numbness and length of time of hand pain episode. There are 11 items in part 1 to give a total out of 55. Part 2 assesses the functional status on a scale from 1 (no difficulty) to 5 (cannot perform the activity at all due to symptoms). Some items questioned include writing, buttoning of clothes and opening of jars. There are 8 items in part 2 to give a total out of 40. Subjects who rank at least 1 item with a score 3 or higher will be considered during the screening process as'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['OMM', 'OMT', 'Osteopathic', 'Osteopathic Manipulation', 'Osteopathic Manipulative Medicine'], 'conditions': ['Carpal Tunnel Syndrome (CTS)']}, 'referencesModule': {'references': [{'pmid': '39938541', 'type': 'BACKGROUND', 'citation': 'Zhan L, Brown J, Gustowski S, Davis P, Loomis M. Carpal tunnel dimensions following osteopathic manipulation utilizing dorsal carpal arch muscle energy: a pilot study. J Osteopath Med. 2025 Feb 13;125(8):417-423. doi: 10.1515/jom-2024-0167. eCollection 2025 Aug 1.'}, {'pmid': '22411967', 'type': 'BACKGROUND', 'citation': 'Siu G, Jaffe JD, Rafique M, Weinik MM. Osteopathic manipulative medicine for carpal tunnel syndrome. J Am Osteopath Assoc. 2012 Mar;112(3):127-39.'}, {'pmid': '39338086', 'type': 'BACKGROUND', 'citation': 'Krieger Y, Ofri M, Sagi G, Moshe-Noach H, Raiden P, Shoham Y, Sagi A, Reiner Benaim A, Silberstein E. Long-Term Functional Outcomes and Quality of Life Following Carpal Tunnel Release Surgery. Int J Environ Res Public Health. 2024 Sep 11;21(9):1203. doi: 10.3390/ijerph21091203.'}, {'pmid': '36848651', 'type': 'BACKGROUND', 'citation': "Karjalainen TV, Lusa V, Page MJ, O'Connor D, Massy-Westropp N, Peters SE. Splinting for carpal tunnel syndrome. Cochrane Database Syst Rev. 2023 Feb 27;2(2):CD010003. doi: 10.1002/14651858.CD010003.pub2."}, {'type': 'BACKGROUND', 'citation': 'Baxter, S., Millhuff, A., Desai, G., & Dowling, D. (2021). An Osteopathic Approach to Carpal Tunnel Syndrome. Osteopathic Family Physician, 13(6). https://doi.org/10.33181/13054'}]}, 'descriptionModule': {'briefSummary': 'Carpal Tunnel Syndrome (CTS) can be defined as disruption of the median nerve and is characterized by pain, numbness and tingling of the lateral 3.5 digits of the hand. In severe cases, motor function can also be disrupted. There are many factors that can contribute to the development of CTS: inflammation, compression, bony abnormality, mechanical injury, or certain lifestyle choices. Abnormalities have been proven to be tangibly visible with ultrasound in prior research projects in the form of decreased cross sectional area of the carpal tunnel, flattening of the median nerve, retinacular bowing and increased median nerve intensity. Although CTS has proven to be multifactorial, the standard of care for patients with CTS has historically been wrist immobilization and/or surgical release by endoscopic or open approach. This is despite evidence that osteopathic manipulation techniques have been effective in improving quality of life for patients with CTS.\n\nPatients will not be harmed if they are not bracing, as standard of care may include multiple things: bracings vs. OMM vs. surgical release.\n\nOur study will take place over the course of 10 weeks. Patients who have been previously diagnosed with mild or moderate carpal tunnel syndrome by a physician previously will be randomly placed into one of two groups: osteopathic manipulative medicine or bracing. If placed in the bracing category, patients will be given a brace and asked to wear it nightly. If placed in the osteopathic manipulative medicine category, patients will be asked to present to the clinic one time a week for 6 weeks. Each time the patient presents to clinic, they will be treated for 30 minutes.\n\nfor 30 minutes of osteopathic manipulative medicine for 6 consecutive weeks.\n\nAt the first presentation, patients will obtain a magnetic resonance image of the affected wrist, from which a cross sectional area will be determined. Repeat magnetic resonance image will be obtained at the conclusion of treatment.\n\nAdditionally, at the first presentation, 3 weeks into the study, at the end of the study and 4 weeks after the study is completed, each subject will complete the Boston Carpal Tunnel Questionnaire. Descriptive and repeated measures statistical analysis will be performed.', 'detailedDescription': 'Eligibility for participation in the study will be determined by Dr. Jordan Keys and Dr. Priya Bhushan. Additionally, and as, a part of the screening process, all participants will complete the Boston Carpal Tunnel Questionnaire. Patients who rank at least 1 item in each subsection of the Boston Carpal Tunnel Questionnaire with a score 3 or higher will meet the inclusion criteria for our study and will hence continue with consent. Once informed consent is obtained, patients will be randomly assigned to either the osteopathic manipulative medicine or bracing groups. Subjects will choose out of a bag to determine which group they will be in. Papers in the bag will either have the number "1" or "2." Subjects who pick number 1 will be placed in the bracing group. Subjects who pick number 2 will be placed in the osteopathic manipulation group. A magnetic resonance imaging of the affected wrist will also be obtained at the time of consent. Each patient\'s name and date of birth will be entered into the MRI. At that time, a medical ID number will also be assigned, which will be used to de-identify patients in data storage and collection. Dr. Gabriel Gelves will reassess eligibility for magnetic resonance imaging through the Magnetic Resonance Imaging Screening tool, and he and/or an MRI technician will obtain the MRI. They shall be certified radiologists or physicians with a background in radiology. Volumetric analysis of the visualized Carpal Tunnel will be obtained at several key landmarks using coronal, axial and sagittal views. The scans may take up to 1 hour and will occur in the BRIIC Building. The depth and transverse measurements of the of the Carpal Tunnel along with the morphology of the Median nerve will be analyzed. From that, cross sectional area of the carpal tunnel will be determined and recorded in an encrypted excel sheet. Patients who are placed in the bracing group will be given an Apollo Wrist Brace and informed on how to properly use the brace. They will be asked to wear the brace consistently at night, while sleeping, for 6 weeks. They will be expected to wear the brace for at least 8 hours, to simulate and standardize wearing it while sleeping. These hours will overlap with how long each patient sleeps. The Apollo Wrist Brace will be used because it is constructed of soft and comfortable foam material that allows for maximum hand function. It has universal sizing and is specifically designed to hold the wrist in a neutral position which is optimal for minimizing median nerve compression. The brace provides sufficient immobilization without being too bulky which will increase patient compliance, especially during sleep. It will be considered the standard of care for conservative carpal tunnel treatment. However, it is important to note that patients will not be harmed if they are not bracing, as standard of care may include multiple things: bracings vs. OMM vs. surgical release.\n\nPatients who are assigned to the osteopathic manipulative medicine group will be scheduled to undergo 6 weekly osteopathic manipulative treatment sessions with either Dr. Jordan Keys, Dr. Priya Bhushan or other qualified team member. The protocol for the weekly sessions, developed by osteopathic physicians, will include assessment and treatment of the nervous system (somatic and autonomic), lymphatic drainage and biomechanical structures impacting the function of the upper extremity. The following protocol will be followed- order of treatment dependent upon osteopathic physician treating patient - the order of treatment will depend upon osteopathic physician treating patient Thoracic Outlet Release Thoracic spine treatment (physician will treat somatic dysfunctions (SD) they find with OMT treatment of their choice). This will include assessment of the mid- thoracic region for viscerosomatic changes to the upper extremity). Cervical Spine (physician will treat SD they find with treatment of their choice) Upper extremity treatment will include assessment and treatment of the myofascial structures including the interosseous membrane as well as assessment and treatment of the carpal bones and the flexor retinaculum. Thoracoabdominal Diaphragm release Any additional pertinent SD will be treated as determined by Osteopathic Physician (this will be documented for each patient/each session) Potential treatments will include Counterstrain, Muscle Energy Technique, Facilitated Positional Release, Balanced Ligamentous Tension, High Velocity Low Amplitude, etc.). Treatment will be at the discretion of the performing physician. The treatments administered will be documented through an OMT evaluation form by either Brianna Alexis Nazario M.S. OMS-1 or Georgios Kutrubis OMS-1. After 3 weeks of treatment, all participants will be asked to complete the Boston Carpal Tunnel Syndrome Questionnaire a second time. This will be administered through RedCap. After 6 weeks, treatment will be completed. On the day of their last session, all patients undergoing osteopathic manipulative treatment will undergo a repeat MRI of the wrist, from which the cross sectional area will be obtained again. Patients who were assigned to the bracing group will report to the clinic again after 6 weeks of using the brace. At that time repeat MRI will be obtained. Cross sectional areas will be obtained and recorded.\n\nPatients will also be asked to complete the Boston Carpal Tunnel Syndrome Questionnaire a third time through RedCap. One month after treatment, the patients will complete the Boston Carpal Tunnel Syndrome Questionnaire for the final time. Statistical analysis of the cross sectional area of the carpal tunnel for each subject will be completed using the Wilcoxon signed-rank test. Statistical analysis comparing the efficacies of bracing and osteopathic manipulative treatment will be completed using Mann-Whitney U test. All data will be displayed through several box and whisker plot graphs, as recommended by Dr. Jung. The two control group\'s scores on the Boston Carpal Tunnel Questionnaire over the course of treatment will be displayed on one graph. Another graph will display the difference in the carpal tunnel cross sectional area throughout treatment, obtained through MRI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have been diagnosed with mild/moderate carpal tunnel syndrome\n* Patients who are over the age of 18 and patients who score at least a 3 in at least one category in both subsections of the Boston Carpal Tunnel Questionnaire.\n* Exclusion criteria:\n* Patients who are under the age of 18\n* Patients who are pregnant\n* Patients who have found no benefit to their Carpal Tunnel Syndrome Symptoms with bracing\n* Patients who have previously undergone Carpal Tunnel Release\n* Patients who have been diagnosed with osteoporosis, osteomyelitis, underlying bone diseases, severe rheumatoid arthritis or other inflammatory arthritis.\n* Patients with magnetic resonance imaging specific contraindications include patients with metallic implanted devices or retained metallic foreign bodies, patients with severe and uncontrolled claustrophobia and patients who are pregnant'}, 'identificationModule': {'nctId': 'NCT07432750', 'acronym': 'OMM', 'briefTitle': 'Comparing Efficacy of Osteopathic Manipulation vs. Wrist Immobilization for Carpal Tunnel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'New York Institute of Technology'}, 'officialTitle': 'Comparing Efficacy of Osteopathic Manipulation vs. Wrist Immobilization for Carpal Tunnel Syndrome Using Magnetic Resonance Imaging and Patient Perception', 'orgStudyIdInfo': {'id': 'NYIT IRB-2025-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Osteopathic Manipulative Treatment (OMT)', 'description': 'Patient will be seen for 6 weekly OMT sessions. The following treatments will be performed. Thoracic Outlet Release, Thoracic spine treatment (physician will treat somatic dysfunctions (SD) they find with OMT treatment of their choice). This will include assessment of the mid- thoracic region for viscerosomatic changes to the upper extremity). Cervical Spine (physician will treat SD they find with treatment of their choice) Upper extremity treatment will include assessment and treatment of the myofascial structures including the interosseous membrane as well as assessment and treatment of the carpal bones and the flexor retinaculum. Thoracoabdominal Diaphragm release Any additional pertinent SD will be treated as determined by Osteopathic Physician (this will be documented for each patient/each session)', 'interventionNames': ['Procedure: Osteopathic Manipulative Treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Wrist Immobilization Brace', 'description': 'Patients will be supplied with a wrist immobilizer for the 6 weeks instead of OMT. This is the current standard of care.', 'interventionNames': ['Device: Wrist Immobilizer']}], 'interventions': [{'name': 'Osteopathic Manipulative Treatment', 'type': 'PROCEDURE', 'description': 'Patients who are assigned to the osteopathic manipulative medicine group will be scheduled to undergo 6 weekly osteopathic manipulative treatment sessions with either Dr. Jordan Keys, Dr. Priya Bhushan or other qualified team member. The protocol for the weekly sessions, developed by osteopathic physicians, will include assessment and treatment of the nervous system (somatic and autonomic), lymphatic drainage and biomechanical structures impacting the function of the upper extremity. The following protocol will be followed- order of treatment dependent upon osteopathic physician treating patient - the order of treatment will depend upon osteopathic physician treating patient Thoracic Outlet Release Thoracic spine treatment (physician will treat somatic dysfunctions (SD) they find with OMT treatment of their choice). This will include assessment of the mid- thoracic region for viscerosomatic changes to the upper extremity). Cervical Spine (physician will treat SD they find with treatmen', 'armGroupLabels': ['Osteopathic Manipulative Treatment (OMT)']}, {'name': 'Wrist Immobilizer', 'type': 'DEVICE', 'description': 'Patient will be supplied with a wrist immobilizer to wear for 6 weeks instead of OMT.', 'armGroupLabels': ['Wrist Immobilization Brace']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11568', 'city': 'Old Westbury', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jordan Keys, DO', 'role': 'CONTACT', 'email': 'jordan.keys@nyit.edu', 'phone': '8058953022'}, {'name': 'Jordan Keys, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Gabe Gelves, DO', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Priya Bhushan, DO', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jennifer Maccagnano, DO', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'New York Institute of Technology', 'geoPoint': {'lat': 40.78871, 'lon': -73.59957}}], 'centralContacts': [{'name': 'Jordan Keys, DO', 'role': 'CONTACT', 'email': 'jordan.keys@nyit.edu', 'phone': '1 (805)895-3022'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We do not plan to publish in ICMJE'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York Institute of Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Dean of Research Collaboration and Innovation, Principal Investigator, Clinical Associate Professor', 'investigatorFullName': 'Jordan Keys', 'investigatorAffiliation': 'New York Institute of Technology'}}}}