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 (COMET-AOA)

Kettering Health Network

Status: Enrolling

Conditions: Carpal Tunnel Syndrome

Treatments: Other: Conservative treatment; Other: Osteopathic manipulative treatment (OMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06150443

KHN-2023-130

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of unilateral or bilateral mild to moderate carpal tunnel syndrome, based on recent EMG findings

Exclusion criteria

• History of undergoing recent physical therapy for treatment of carpal tunnel syndrome
• History of wrist trauma or surgery
• Hypothyroidism
• Severe CTS that has progressed to muscle atrophy
• Systemic disease or condition including but not limited to diabetes mellitus, thyroid disorders, rheumatoid disorders, Paget's bone disease, gout, myxedema, multiple myeloma, acromegaly, hepatic disease, dialysis patients, or other diseases or conditions in which peripheral neuropathies are common.
• Secondary cause of CTS such as a ganglion cyst, mass, or an accessory muscle shown by US or MRI of the affected wrist.
• Bifid median nerve as shown by US or MRI of the affected wrist
• pregnant or recently postpartum

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

Group 1 - OMT Only

Experimental group

Description:

Osteopathic manipulative treatment will include the interosseous membrane technique, the flexor retinaculum soft tissue technique, and the radiocarpal somatic dysfunction technique. The cervical spine will also be treated, with particular attention to the C5-7 levels, all the way to the wrist and hand as the physician sees fit based on the findings of the osteopathic structural exam.

Treatment:

Other: Osteopathic manipulative treatment (OMT)

Group 2 - OMT + Conservative Treatment

Active Comparator group

Description:

Will receive Osteopathic manipulative treatment in addition to 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 and Occupational therapy will be excluded from the conservative therapy regimen. Osteopathic manipulative treatment will include the interosseous membrane technique, the flexor retinaculum soft tissue technique, and the radiocarpal somatic dysfunction technique. The cervical spine will also be treated, with particular attention to the C5-7 levels, all the way to the wrist and hand as the physician sees fit based on the findings of the osteopathic structural exam.

Treatment:

Other: Osteopathic manipulative treatment (OMT)

Other: Conservative treatment

Group 3 - Conservative Treatment Only

Active Comparator group

Description:

Conservative therapy will be defined as including the use of splints, NSAIDs, opioids, and therapeutic injection of the carpal tunnel with steroids. Physical and Occupational therapy will be excluded from the conservative therapy regimen.

Treatment:

Other: Conservative treatment