Intraneural Facilitation as a Treatment for Carpal Tunnel Syndrome

• ClinicalTrials.gov Identifier: NCT03205683
• Recruitment Status: Completed
• First Posted: July 2, 2017
• Last Update Posted: September 10, 2019
• Sponsor: Loma Linda University
• Information provided by (Responsible Party): Bryan Tsao, Loma Linda University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Carpal Tunnel Syndrome	Other: Intraneural facilitation (INF); Other: Sham INF	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Intraneural Facilitation as a Treatment for Carpal Tunnel Syndrome
• Actual Study Start Date: January 29, 2018
• Actual Primary Completion Date: February 22, 2019
• Actual Study Completion Date: February 22, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Other: 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.
Sham Comparator: 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.	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.

Outcome Measures

Primary Outcome Measures :

1. The Boston CTS Questionnaire symptom severity scale and functional assessment. [ Time Frame: change between baseline and one week after completion of INF therapy ]
   composite measurement of carpal tunnel symptomology (pain and numbness) and functional assessment
2. The Boston CTS Questionnaire symptom severity scale and functional assessment. [ Time Frame: change between week 1 and 3 months after completion of INF therapy ]
   composite measurement of carpal tunnel symptomology (pain and numbness) and functional assessment

Secondary Outcome Measures :

1. Visual analog scale (VAS) [ Time Frame: change between baseline and one week after completion of INF therapy ]
   an ordinal standardized scale grading pain from 0 (absent) to 10 (greatest)
2. Visual analog scale (VAS) [ Time Frame: change between week 1 and 3 months after completion of INF therapy ]
   an ordinal standardized scale grading pain from 0 (absent) to 10 (greatest)
3. Ultrasound [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 74 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, California

Loma Linda University Health

Loma Linda, California, United States, 92354

Sponsors and Collaborators

Loma Linda University

Investigators

• Principal Investigator: Bryan Tsao, MD; Loma Linda University

More Information

• Responsible Party: Bryan Tsao, Neurology Chairman, Loma Linda University
• ClinicalTrials.gov Identifier: NCT03205683
• Other Study ID Numbers: 5170247
• First Posted: July 2, 2017
• Last Update Posted: September 10, 2019
• Last Verified: September 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Carpal Tunnel Syndrome; Syndrome; Disease; Pathologic Processes; Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries