Clinical trial NCT03205683: Intraneural Facilitation as a Treatment for Carpal Tunnel Syndrome
Official title: Intraneural Facilitation as a Treatment for Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Boston CTS Questionnaire symptom severity scale and functional assessment.
timeFrame: change between baseline and one week after completion of INF therapy
measure: The Boston CTS Questionnaire symptom severity scale and functional assessment.
timeFrame: change between week 1 and 3 months after completion of INF therapy
Secondary outcomes:
measure: Visual analog scale (VAS)
timeFrame: change between baseline and one week after completion of INF therapy
measure: Visual analog scale (VAS)
timeFrame: change between week 1 and 3 months after completion of INF therapy
measure: Ultrasound
timeFrame: change between baseline and one week after completion of INF therapy
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Health
state: California
Study officials:
affiliation: Loma Linda University
name: Bryan Tsao, MD
role: PRINCIPAL_INVESTIGATOR
References: