Back to resultsIntraneural Facilitation as a Treatment for Carpal Tunnel Syndrome
Primary Purpose
Carpal Tunnel Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intraneural facilitation (INF)
Sham INF
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome
Eligibility Criteria
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
Sites / Locations
- Loma Linda University Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Intraneural facilitation therapy
Sham therapy
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
The Boston CTS Questionnaire symptom severity scale and functional assessment.
composite measurement of carpal tunnel symptomology (pain and numbness) and functional assessment
The Boston CTS Questionnaire symptom severity scale and functional assessment.
composite measurement of carpal tunnel symptomology (pain and numbness) and functional assessment
Secondary Outcome Measures
Visual analog scale (VAS)
an ordinal standardized scale grading pain from 0 (absent) to 10 (greatest)
Visual analog scale (VAS)
an ordinal standardized scale grading pain from 0 (absent) to 10 (greatest)
Ultrasound
Reduction in diameter of the median nerve at the wrist or in the distal forearm ratio
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03205683
Brief Title
Intraneural Facilitation as a Treatment for Carpal Tunnel Syndrome
Official Title
Intraneural Facilitation as a Treatment for Carpal Tunnel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 29, 2018 (Actual)
Primary Completion Date
February 22, 2019 (Actual)
Study Completion Date
February 22, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intraneural facilitation therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham therapy
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Intraneural facilitation (INF)
Intervention Description
INF is a novel non-invasive therapy based on the principle of restoring vascular function at the capillary level in peripheral nerve.
Intervention Type
Other
Intervention Name(s)
Sham INF
Intervention Description
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 Outcome Measure Information:
Title
The Boston CTS Questionnaire symptom severity scale and functional assessment.
Description
composite measurement of carpal tunnel symptomology (pain and numbness) and functional assessment
Time Frame
change between baseline and one week after completion of INF therapy
Title
The Boston CTS Questionnaire symptom severity scale and functional assessment.
Description
composite measurement of carpal tunnel symptomology (pain and numbness) and functional assessment
Time Frame
change between week 1 and 3 months after completion of INF therapy
Secondary Outcome Measure Information:
Title
Visual analog scale (VAS)
Description
an ordinal standardized scale grading pain from 0 (absent) to 10 (greatest)
Time Frame
change between baseline and one week after completion of INF therapy
Title
Visual analog scale (VAS)
Description
an ordinal standardized scale grading pain from 0 (absent) to 10 (greatest)
Time Frame
change between week 1 and 3 months after completion of INF therapy
Title
Ultrasound
Description
Reduction in diameter of the median nerve at the wrist or in the distal forearm ratio
Time Frame
change between baseline and one week after completion of INF therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan Tsao, MD
Organizational Affiliation
Loma Linda University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University Health
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intraneural Facilitation as a Treatment for Carpal Tunnel Syndrome
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