Intraneural Facilitation as a Treatment for Carpal Tunnel Syndrome

We hypothesize that a standard course of INF can result in significant improvement in CTS as measured by clinical, electrodiagnostic, or ultrasound measures.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Other: Intraneural facilitation (INF); Other: Sham INF

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 74 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Boston CTS Questionnaire symptom severity scale and functional assessment.	composite measurement of carpal tunnel symptomology (pain and numbness) and functional assessment	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	change between week 1 and 3 months after completion of INF therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog scale (VAS)	an ordinal standardized scale grading pain from 0 (absent) to 10 (greatest)	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)	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	change between baseline and one week after completion of INF therapy

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Bryan Tsao, MD, Loma Linda University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 29, 2018
• Primary Completion (ACTUAL): February 22, 2019
• Study Completion (ACTUAL): February 22, 2019

Study Registration Dates

• First Submitted: June 29, 2017
• First Submitted That Met QC Criteria: June 29, 2017
• First Posted (ACTUAL): July 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 10, 2019
• Last Update Submitted That Met QC Criteria: September 6, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: 5170247

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No