Osteopathic Manipulation vs Wrist Immobilization for Carpal Tunnel Syndrome

(OMM Trial)

Overseen By Jordan Keys, DO

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: New York Institute of Technology

Disqualifiers: Under 18, Pregnant, Previous carpal release, Osteoporosis, Rheumatoid arthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 6 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am over 18 and scored 3 or higher in both parts of the Boston Carpal Tunnel Questionnaire.

I have been diagnosed with mild or moderate carpal tunnel syndrome.

Exclusion Criteria

Patients who are pregnant

I have had carpal tunnel release surgery before.

I have been diagnosed with a serious bone or joint disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive either osteopathic manipulative medicine or wrist immobilization for 6 weeks

6 weeks

6 visits (in-person) for OMT group, 1 visit (in-person) for bracing group

Follow-up

Participants are monitored for safety and effectiveness after treatment, including completion of the Boston Carpal Tunnel Questionnaire

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Osteopathic Manipulative Treatment
• Wrist Immobilizer

How Is the Trial Designed?

Group I: Osteopathic Manipulative Treatment (OMT) Experimental Treatment 1 Intervention

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)

Group II: Wrist Immobilization Brace Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

New York Institute of Technology

Lead Sponsor

Trials

56

Recruited

2,300+