Recruiting

OMM & Bracing

Sponsor:

New York Institute of Technology

Code:

NCT07432750

Conditions

Carpal Tunnel Syndrome (CTS)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Osteopathic Manipulative Treatment

Wrist Immobilizer

Study Details

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)

Study ID

NCT07432750

Start date

Mar, 2026

Status verified date

Feb, 2026

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Aug 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.
  • Exclusion criteria:
  • 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

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Osteopathic Manipulative Treatment (OMT)

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)

active comparator: Wrist Immobilization Brace

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

Interventions

Osteopathic Manipulative Treatment

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

Wrist Immobilizer

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

Primary outcome measure

  • Magnetic Resonance Imaging [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Jordan Keys, DO

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

Locations

New York Institute of Technology

Recruiting

Old Westbury, New York, United States, 11568

Contacts

Jordan Keys, DO

8058953022jordan.keys@nyit.edu

Principal Investigator:

Jordan Keys, DO

More Information

Sponsor

New York Institute of Technology

Last update posted

Feb 25, 2026

Last verified

Feb, 2026

Keywords

  • OMM
  • OMT
  • Osteopathic
  • Osteopathic Manipulation
  • Osteopathic Manipulative Medicine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New York Institute of Technology on 2026-02-25.