Carpal Tunnel Syndrome
Conditions
Brief summary
We hypothesize that a standard course of INF can result in significant improvement in CTS as measured by clinical, electrodiagnostic, or ultrasound measures.
Detailed description
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.
Interventions
OTHERIntraneural facilitation (INF)
INF is a novel non-invasive therapy based on the principle of restoring vascular function at the capillary level in peripheral nerve.
OTHERSham 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.
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 74 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients referred to the LLUH Neurology Electrodiagnostic Laboratory with electrodiagnostic and clinical evidence of CTS (uni- or bilateral) 2. Ages \>18 and \< 75 (irrespective of gender) 3. Current use of splints as long as the frequency of treatment is unaltered and onset of use is \> 1 week in duration
Exclusion criteria
1. Prior carpal tunnel release \> 2 years ago 2. The presence of any condition that would prevent NCS from accurately diagnosing CTS (e.g., hereditary polyneuropathy or acquired demyelinating polyneuropathy) 3. Workman's Compensation cases 4. Pregnancy 5. Undergoing conservative or surgical/injection therapy (physical or occupational therapy, injections) 6. Clinically silent CTS in face of positive electrodiagnostic results 7. Sufficiently severe clinical symptoms that warrant more aggressive therapy i.e., carpal injections or release 8. Any confounding medical condition that the investigator deems may adversely affect subject participation or outcomes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Boston CTS Questionnaire symptom severity scale and functional assessment. | change between baseline and one week after completion of INF therapy | composite measurement of carpal tunnel symptomology (pain and numbness) and functional assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual analog scale (VAS) | change between baseline and one week after completion of INF therapy | an ordinal standardized scale grading pain from 0 (absent) to 10 (greatest) |
| Ultrasound | 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 |
Countries
United States
Outcome results
None listed