An interventional study of Intraneural facilitation (INF) and Sham INF in Carpal Tunnel Syndrome, sponsored by Loma Linda University. Completed at 1 site in United States. Open to participants aged 19 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-10.
Sponsored by Loma Linda University · Not applicable, Interventional, and Treatment
We hypothesize that a standard course of INF can result in significant improvement in CTS as measured by clinical, electrodiagnostic, or ultrasound measures.
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.
605 studies on the registry are indexed under Carpal Tunnel Syndrome; 138 are open to participants now.
This study's enrollment of 10 is below the median of 60 across 457 interventional studies indexed under Carpal Tunnel Syndrome.
Browse Carpal Tunnel Syndrome studies →Loma Linda University is the lead sponsor of 305 studies on the registry; 48 are open to participants now.
Of its 29 completed or terminated interventional studies of FDA-regulated products, 23 (79%) have results posted.
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Exclusion Criteria:
The intraneural facilitation intervention is a novel manual physical therapy approach with anecdotal evidence in neuropathic pain symptoms through biasing blood flow from an artery through the nutrient vessels into the epineurium of an accompanying nerve. The main concept of intraneural facilitation is the use of two manual holds. The first hold is called facilitation hold and includes putting the contralateral joint in a maximal loose-pack position that is comfortable to the patient. The hypothesis with this initial hold is the nerve will have greater excursion the accompanying artery and the nutrient vessels that are clustered at the joint will be stretched. This stretch may enlarge the opening at the junction of the artery and bridging nutrient vessel, therefore consistently creating a vascular bias into the neural epineurial capillaries. Theoretically, this creates increased epifascicular vascular pressure which may be absent due to epineurial ischemia.
Other: Intraneural facilitation (INF)
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 Each visit will last about 45 minutes, twice a week for 6 weeks (total 12 sessions). Missing \> 4 sessions will invalidate subject outcomes.
Other: Sham INF
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.
The Boston CTS Questionnaire symptom severity scale and functional assessment.
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
The Boston CTS Questionnaire symptom severity scale and functional assessment.
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
Visual analog scale (VAS)
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
Visual analog scale (VAS)
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
Ultrasound
Reduction in diameter of the median nerve at the wrist or in the distal forearm ratio
Time frame: change between baseline and one week after completion of INF therapy
Plan to share: No
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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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