Intraneural Facilitation as a Treatment for Carpal Tunnel Syndrome

NCT03205683 | Completed

• 1 other identifier: 5170247
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Visual analog scale (VAS)

  change between baseline and one week after completion of INF therapy

• Visual analog scale (VAS)

  change between week 1 and 3 months after completion of INF therapy

• Ultrasound

  change between baseline and one week after completion of INF therapy

Study Arms (2)

Intraneural facilitation therapy

EXPERIMENTAL

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)

Sham therapy

SHAM COMPARATOR

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

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.

Intraneural facilitation therapy

Sham INF 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.

Sham therapy

Eligibility Criteria

• Age: 19 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients referred to the LLUH Neurology Electrodiagnostic Laboratory with electrodiagnostic and clinical evidence of CTS (uni- or bilateral)
• Ages \>18 and \< 75 (irrespective of gender)
• Current use of splints as long as the frequency of treatment is unaltered and onset of use is \> 1 week in duration

You may not qualify if:

• Prior carpal tunnel release \> 2 years ago
• The presence of any condition that would prevent NCS from accurately diagnosing CTS (e.g., hereditary polyneuropathy or acquired demyelinating polyneuropathy)
• Workman's Compensation cases
• Pregnancy
• Undergoing conservative or surgical/injection therapy (physical or occupational therapy, injections)
• Clinically silent CTS in face of positive electrodiagnostic results
• Sufficiently severe clinical symptoms that warrant more aggressive therapy i.e., carpal injections or release
• Any confounding medical condition that the investigator deems may adversely affect subject participation or outcomes

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Health

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Bryan Tsao, MD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurology Chairman

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: July 2, 2017
• Study Start: January 29, 2018
• Primary Completion: February 22, 2019
• Study Completion: February 22, 2019
• Last Updated: September 10, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)