Clinical trial NCT06150443: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Kettering Health Network
Sponsor class: OTHER
Collaborators: name: American Osteopathic Association
First posted: 2023-11-29
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Elasticity of median nerve at the carpal tunnel inlet
timeFrame: baseline, post 2-week treatment, post 4-week treatment, post 6-week treatment
measure: Cross-sectional area of median nerve in 3 locations
timeFrame: baseline, post 2-week treatment, post 4-week treatment, post 6-week treatment
measure: Quick DASH Patient Survey Score
timeFrame: Completed at treatment visits (initial, 2 weeks, 4 weeks, and 6 weeks)
measure: CTS-6 Evaluation Tool Score
timeFrame: Completed at treatment visits (initial, 2 weeks, 4 weeks, and 6 weeks)
measure: Elasticity of the transverse carpal ligament
timeFrame: baseline, post 2-week treatment, post 4-week treatment, post 6-week treatment
measure: Elasticity of the subsynovial connective tissue in the carpal tunnel
timeFrame: baseline, post 2-week treatment, post 4-week treatment, post 6-week treatment
Secondary outcomes:
measure: Motor Distal Latency
timeFrame: Baseline and at 8 weeks (end of study)
measure: Sensory Distal Latency
timeFrame: Baseline and at 8 weeks (end of study)
Other outcomes:
Locations:
city: Dayton
country: United States
facility: Kettering Health
state: Ohio
Study officials:
affiliation: Kettering Health
name: Roland Gazaille, DO
role: PRINCIPAL_INVESTIGATOR
References: