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

NCT06150443 | Completed

• 1 other identifier: KHN-2023-130
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (6)

• Elasticity of median nerve at the carpal tunnel inlet

  Measured by shear wave elastography.

  baseline, post 2-week treatment, post 4-week treatment, post 6-week treatment

• Cross-sectional area of median nerve in 3 locations

  Measured by real-time grayscale ultrasound

  baseline, post 2-week treatment, post 4-week treatment, post 6-week treatment

• Quick DASH Patient Survey Score

  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.

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

• CTS-6 Evaluation Tool Score

  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.

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

• Elasticity of the transverse carpal ligament

  Measured by shear wave elastography.

  baseline, post 2-week treatment, post 4-week treatment, post 6-week treatment

• Elasticity of the subsynovial connective tissue in the carpal tunnel

  Measured by shear wave elastography.

  baseline, post 2-week treatment, post 4-week treatment, post 6-week treatment

Secondary Outcomes (2)

• Motor Distal Latency

  Baseline and at 8 weeks (end of study)

• Sensory Distal Latency

  Baseline and at 8 weeks (end of study)

Study Arms (3)

Group 1 - OMT Only

EXPERIMENTAL

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.

Other: Osteopathic manipulative treatment (OMT)

Group 2 - OMT + Conservative Treatment

ACTIVE COMPARATOR

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.

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

Group 3 - Conservative Treatment Only

ACTIVE COMPARATOR

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.

Other: Conservative treatment

Interventions

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.

Group 1 - OMT Only; Group 2 - OMT + Conservative Treatment

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.

Group 2 - OMT + Conservative Treatment; Group 3 - Conservative Treatment Only

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• American Osteopathic Association: collaborator
• Kettering Health Network: lead

Study Sites (1)

Kettering Health

Dayton, Ohio, 45458, United States

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Manipulation, Osteopathic; Conservative Treatment

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Roland Gazaille, DO

  Kettering Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 29, 2023
• Study Start: April 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: June 1, 2025
• Last Updated: February 25, 2026

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)