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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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 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.
Kettering Health
Dayton, Ohio, United States
Elasticity of median nerve at the carpal tunnel inlet
Measured by shear wave elastography.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Completed at treatment visits (initial, 2 weeks, 4 weeks, and 6 weeks)
Elasticity of the transverse carpal ligament
Measured by shear wave elastography.
Time frame: 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.
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Time frame: baseline, post 2-week treatment, post 4-week treatment, post 6-week treatment
Motor Distal Latency
Time it takes for an impulse to traverse the segment nearest the muscle.
Time frame: Baseline and at 8 weeks (end of study)
Sensory Distal Latency
Time it takes for an impulse to traverse the segment nearest the muscle.
Time frame: Baseline and at 8 weeks (end of study)