Loma Linda University Health
Loma Linda, California, 92354, United States
NCT Number: NCT03205683
We hypothesize that a standard course of INF can result in significant improvement in CTS as measured by clinical, electrodiagnostic, or ultrasound measures.
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Notify Me19 year–74 year
All sexes
Interventional
Not applicable
Loma Linda, California, 92354, United States
INF is a novel non-invasive therapy based on the principle of restoring vascular function at the capillary level in peripheral nerve. his therapy has been shown to improve clinical function in patients with diabetic-associated polyneuropathy, a model for various forms of ischemic neuropathy. CTS is a common condition where regional compression at the wrist results in ischemic focal demyelination of the distal median nerve. This results in sensory dysfunction, pain, and eventually axon loss and weakness if the compression is sufficiently severe and prolonged. Standard therapy for CTS includes wrist splints, regional lidocaine injections, ergonomic adjustments, various forms of occupation therapy, and ultimately surgical release of the carpal tunnel ligament. However, all of these are either temporary in their effect or invasive. The diagnosis of CTS relies on clinical, electrodiagnostic or NCS, and ultrasound methods.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
INF is a novel non-invasive therapy based on the principle of restoring vascular function at the capillary level in peripheral nerve.
Will be performed by a different therapist than actual INF. The patient will be asked to do the following combination of passive range of motion (PROM) and active ROM activities to promote blood flow in the affected arm.
Time frame: change between baseline and one week after completion of INF therapy
composite measurement of carpal tunnel symptomology (pain and numbness) and functional assessment
Time frame: change between week 1 and 3 months after completion of INF therapy
composite measurement of carpal tunnel symptomology (pain and numbness) and functional assessment
Time frame: change between baseline and one week after completion of INF therapy
an ordinal standardized scale grading pain from 0 (absent) to 10 (greatest)
Time frame: change between week 1 and 3 months after completion of INF therapy
an ordinal standardized scale grading pain from 0 (absent) to 10 (greatest)
Time frame: change between baseline and one week after completion of INF therapy
Reduction in diameter of the median nerve at the wrist or in the distal forearm ratio
Loma Linda University
Other
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