Intraneural Facilitation as a Treatment for Carpal Tunnel Syndrome

NCT ID: NCT03205683

Last Updated: 2019-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-29
• Study Completion Date: 2019-02-22

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.

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intraneural facilitation therapy

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.

Group Type: EXPERIMENTAL

Intraneural facilitation (INF)

Intervention Type: OTHER

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

Sham therapy

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.

Group Type: SHAM_COMPARATOR

Sham INF

Intervention Type: OTHER

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.

Interventions

Intraneural facilitation (INF)

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

Intervention Type: OTHER

Sham 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Bryan Tsao

Neurology Chairman

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bryan Tsao, MD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University

Locations

Loma Linda University Health

Loma Linda, California, United States

Countries

United States

Other Identifiers

5170247

Identifier Type: -

Identifier Source: org_study_id