Intraneural Facilitation as a Treatment for Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

Intraneural Facilitation as a Treatment for Carpal Tunnel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03205683
• Other study ID #: 5170247
• Status: Completed
• Phase: N/A
• Start date: January 29, 2018
• Est. completion date: February 22, 2019

Study information

• Verified date: September 2019
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 22, 2019
• Est. primary completion date: February 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

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 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.

Locations

Country	Name	City	State
United States	Loma Linda University Health	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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