NCT07432750 Comparing Efficacy of Osteopathic Manipulation vs. Wrist Immobilization for Carpal Tunnel Syndrome

Eligibility & Interventions

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This trial targets 10 participants in total. It began in 2026-03 with a primary completion date of 2026-08-30.

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.

Eligibility Criteria

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

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