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

Carpal Tunnel Syndrome Clinical Trial

— COMET-AOA  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06150443
• Other study ID #: KHN-2023-130
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2024
• Est. completion date: September 1, 2025

Study information

• Verified date: March 2024
• Source: Kettering Health Network
• Contact: Roland Gazaille, DO
• Phone: 937-297-6307
• Email: roland.gazaille[@]ketteringhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: September 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Kettering Health	Dayton	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Kettering Health Network	American Osteopathic Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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)
Primary	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)
Primary	Elasticity of the transverse carpal ligament	Measured by shear wave elastography.	baseline, post 2-week treatment, post 4-week treatment, post 6-week treatment
Primary	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	Motor Distal Latency	Time it takes for an impulse to traverse the segment nearest the muscle.	Baseline and at 8 weeks (end of study)
Secondary	Sensory Distal Latency	Time it takes for an impulse to traverse the segment nearest the muscle.	Baseline and at 8 weeks (end of study)