NCT06150443

COMET-AOA: Median Nerve Stiffness in Mild-Moderate CTS With OMT & Conservative Therapy

Pilot Study Evaluating the Elasticity and Shear Wave Modulus (Stiffness) of the Median Nerve in Patients With Mild to Moderate Idiopathic Carpal Tunnel Syndrome Receiving OMT and Conservative Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Kettering Health Network · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To evaluate and quantify changes in the elasticity and shear wave modulus (stiffness) of the median nerve in patients diagnosed with mild to moderate carpal tunnel syndrome following osteopathic manipulative therapy.

Detailed description

This small pilot study aimed to investigate whether the imaging modality known as shear wave elastography (SWE) could be used to objectively quantify post treatment changes in the soft tissues of the carpal tunnel as a result of Osteopathic Manipulative Therapy (OMT) in patients with mild to moderate-severe carpal tunnel syndrome (CTS). Patients were randomly assigned into three treatment groups for six weeks: OMT only, traditional conservative care (ie. splits and steroid injections), or a combination of both OMT and conservative therapy. The primary outcome was to evaluate the stiffness of the median nerve, the transverse carpal ligament and the intra-carpal tunnel contents. Our team also used traditional grayscale ultrasound to measure the cross-sectional diameter of the nerve as well as the standard, often uncomfortable, electromyography (EMG) test to assess pre- and post-treatment nerve function. Patient outcomes were tracked using both patient surveys which captured a participant's symptoms and level of function as well as clinician assessment tools. Osteopathic Manipulative Treatment (OMT) was a treatment technique used involving a hands-on exam to diagnose, prevent, and treat various musculoskeletal conditions by addressing structural imbalance in the body's bones and soft tissues. Those subjects in the conservative therapy only group were treated with splint and steroid injections.

Conditions

• Carpal Tunnel Syndrome

Interventions

Type	Name	Description
OTHER	Osteopathic manipulative treatment (OMT)	Two osteopathic primary care physicians will performing osteopathic manipulative techniques with a minimum of three direct techniques focused on carpal tunnel. These techniques will include the interosseous membrane technique, the flexor retinaculum soft tissue technique, and the radiocarpal somatic dysfunction technique. They will also evaluate and treat the cervical spine, with particular attention to the C5-7 levels, all the way to the wrist and hand as they see fit based on the findings of their osteopathic structural exam.
OTHER	Conservative treatment	Conservative therapy will be defined as including the use of splints, NSAIDs, opioids, and therapeutic injection of the carpal tunnel with steroids. Physical therapy will be excluded from the conservative therapy regimen.

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-03-31
• Completion: 2025-06-01
• First posted: 2023-11-29
• Last updated: 2026-02-25

Locations

1 site across 1 country: United States