Carpal Tunnel Syndrome
Conditions
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.
Detailed description
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.
Interventions
OTHEROsteopathic 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.
OTHERConservative 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.
Sponsors
Kettering Health Network
American Osteopathic Association
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Elasticity of median nerve at the carpal tunnel inlet | baseline, post 2-week treatment, post 4-week treatment, post 6-week treatment | Measured by shear wave elastography. |
| Cross-sectional area of median nerve in 3 locations | baseline, post 2-week treatment, post 4-week treatment, post 6-week treatment | Measured by real-time grayscale ultrasound |
| Quick DASH Patient Survey Score | 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. |
| CTS-6 Evaluation Tool Score | 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. |
| Elasticity of the transverse carpal ligament | baseline, post 2-week treatment, post 4-week treatment, post 6-week treatment | Measured by shear wave elastography. |
| Elasticity of the subsynovial connective tissue in the carpal tunnel | baseline, post 2-week treatment, post 4-week treatment, post 6-week treatment | Measured by shear wave elastography. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Motor Distal Latency | Baseline and at 8 weeks (end of study) | Time it takes for an impulse to traverse the segment nearest the muscle. |
| Sensory Distal Latency | Baseline and at 8 weeks (end of study) | Time it takes for an impulse to traverse the segment nearest the muscle. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRoland Gazaille, DO
Kettering Health
Outcome results
None listed