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

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)

Interventions

PROCEDURE

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

DEVICE

Wrist Immobilizer

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

Sponsors & Collaborators

• New York Institute of Technology

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-31

Primary Completion

2026-08-30

Completion

2027-02-28

FDA Device

Yes

Countries

• United States

Study Locations