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OpenTrials
Completed

NCT Number: NCT03205683

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.

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Key information

Age range

19 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University Health

Loma Linda, California, 92354, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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 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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 2, 2017
Registry last updated
Sep 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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