Comparing Efficacy of Osteopathic Manipulation vs. Wrist Immobilization for Carpal Tunnel Syndrome

NCT07432750 | Recruiting FDA Device

• 1 other identifier: NYIT IRB-2025-301
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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. Patients will not be harmed if they are not bracing, as standard of care may include multiple things: bracings vs. OMM vs. surgical release. Our 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. for 30 minutes of osteopathic manipulative medicine for 6 consecutive weeks. At 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. Additionally, 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.

Conditions

Carpal Tunnel Syndrome (CTS)

Keywords

OMM; OMT; Osteopathic; Osteopathic Manipulation; Osteopathic Manipulative Medicine

Outcome Measures

Primary Outcomes (1)

• Magnetic Resonance Imaging

  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. Transverse 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.

  6 weeks

Secondary Outcomes (1)

• Boston Carpal Tunnel Questionnaire

  10 weeks

Study Arms (2)

Osteopathic Manipulative Treatment (OMT)

EXPERIMENTAL

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)

Procedure: Osteopathic Manipulative Treatment

Wrist Immobilization Brace

ACTIVE COMPARATOR

Patients will be supplied with a wrist immobilizer for the 6 weeks instead of OMT. This is the current standard of care.

Device: Wrist Immobilizer

Interventions

Osteopathic Manipulative Treatment PROCEDURE

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

Osteopathic Manipulative Treatment (OMT)

Wrist Immobilizer DEVICE

Patient will be supplied with a wrist immobilizer to wear for 6 weeks instead of OMT.

Wrist Immobilization Brace

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have been diagnosed with mild/moderate carpal tunnel syndrome
• 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.

You may not qualify if:

• Patients who are under the age of 18
• Patients who are pregnant
• Patients who have found no benefit to their Carpal Tunnel Syndrome Symptoms with bracing
• Patients who have previously undergone Carpal Tunnel Release
• Patients who have been diagnosed with osteoporosis, osteomyelitis, underlying bone diseases, severe rheumatoid arthritis or other inflammatory arthritis.
• 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

Sponsors & Collaborators

• New York Institute of Technology: lead

Study Sites (1)

New York Institute of Technology

Old Westbury, New York, 11568, United States

RECRUITING

Related Publications (5)

• 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: 39938541 BACKGROUND

• 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: 22411967 BACKGROUND

• 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: 39338086 BACKGROUND

• 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.

  PMID: 36848651 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Jordan Keys, DO

CONTACT

1 (805)895-3022; jordan.keys@nyit.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean of Research Collaboration and Innovation, Principal Investigator, Clinical Associate Professor

Model Details: One group will receive Osteopathic Manipulative Treatment and one group will receive the standard of care (wrist immobilization splints).

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 25, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)