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Completed

NCT Number: NCT06150443

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

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.

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Key information

Conditions

Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kettering Health

Dayton, Ohio, 45458, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Osteopathic Manipulative Treatment (OMT)

Other

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.

Conservative treatment

Other

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.

Primary outcomes

  1. Elasticity of median nerve at the carpal tunnel inlet

    Time frame: baseline, post 2-week treatment, post 4-week treatment, post 6-week treatment

    Measured by shear wave elastography.

  2. Cross-sectional area of median nerve in 3 locations

    Time frame: baseline, post 2-week treatment, post 4-week treatment, post 6-week treatment

    Measured by real-time grayscale ultrasound

  3. Quick DASH Patient Survey Score

    Time frame: Completed at treatment visits (initial, 2 weeks, 4 weeks, and 6 weeks)

    This questionnaire asks the patient about their symptoms as well as their ability to perform certain activities. The QuickDASH, published in 2005 in the Journal of Bone and Joint Surgery, is a subset of 11 items from the 30-item DASH and is a self-reported questionnaire in which the response options are presented as 5-point Likert scales. At least 10 of the 11 items must be completed for a score to be calculated and the scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb.

  4. CTS-6 Evaluation Tool Score

    Time frame: Completed at treatment visits (initial, 2 weeks, 4 weeks, and 6 weeks)

    The Value Added by Electrodiagnostic Testing in the Diagnosis of Carpal Tunnel Syndrome completed by the clinician. A score >12 = 0.80 probability of Carpal Tunnel Syndrome and a score >5 = 0.25 probability of Carpal Tunnel Syndrome.

  5. Elasticity of the transverse carpal ligament

    Time frame: baseline, post 2-week treatment, post 4-week treatment, post 6-week treatment

    Measured by shear wave elastography.

  6. Elasticity of the subsynovial connective tissue in the carpal tunnel

    Time frame: baseline, post 2-week treatment, post 4-week treatment, post 6-week treatment

    Measured by shear wave elastography.

Secondary outcomes

  1. Motor Distal Latency

    Time frame: Baseline and at 8 weeks (end of study)

    Time it takes for an impulse to traverse the segment nearest the muscle.

  2. Sensory Distal Latency

    Time frame: Baseline and at 8 weeks (end of study)

    Time it takes for an impulse to traverse the segment nearest the muscle.

Sponsors and collaborators

Lead sponsor

Kettering Health Network

Other

Collaborators

  • American Osteopathic Association

Registry information

Official study title

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

Acronym: COMET-AOA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 29, 2023
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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