Intraneural Facilitation as a Treatment for Carpal Tunnel Syndrome

N/ACompletedNCT03205683

Loma Linda University10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Carpal Tunnel Syndrome

Interventions

Intraneural facilitation (INF)OTHER

INF is a novel non-invasive therapy based on the principle of restoring vascular function at the capillary level in peripheral nerve.

Sham INFOTHER

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.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 74 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Loma Linda University Health

Loma Linda, California, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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