Back to resultsThe Effect of Intraneural Facilitation Therapy on Diabetic Patients With Peripheral Neuropathy
Primary Purpose
Diabetic Neuropathy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intraneural Facilitation
Sham
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Neuropathy
Eligibility Criteria
Inclusion Criteria:
- Patients with Diabetes Type 2 and Diabetic Peripheral Neuropathy with no other known underlying disease
- Below ankle Diabetic Peripheral Neuropathy symptoms (numbness, tingling, burning, sharp pain, increased sensitivity, etc.)
- ≥10 on Quality of Life- Diabetic Neuropathy Scale (QOL- DN)
- Between age 50-75 years
Exclusion Criteria:
- Patients with a medical condition that suggested possible decline in function over the next 6 months such as; a current regimen of chemotherapy, radiation therapy, or dialysis
- Any lower extremity amputations or wounds
- Documented active alcohol and/or drug misuse
- Known health conditions: end stage renal failure, uncontrolled hypertension, severe dyslipidemia, chronic liver disease, autoimmune disease, advanced chronic obstructive pulmonary disease and active inflammations
- DM patients with inflammatory neuropathies including chronic inflammatory demyelinating polyneuropathy (CIDP), proximal diabetes neuropathy, and autonomic neuropathies
- Patients with other types of neuropathies not associated with Diabetes Mellitus such as B12 deficiency, hypothyroidism, and uremia
- Other severe chronic medical condition requiring active treatment
- Morbidly Obese patients
- Pregnancy (self reported)
Sites / Locations
- Loma Linda University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Group 1
Group 2
Arm Description
Intraneural facilitation treatment for 50-60 minutes. 50 minutes if ultrasound received. 9 total treatment visits, 3 visits per week • One 50-60 minute visit on Monday, Wednesday and Friday, for 3 weeks.
SHAM treatment for 50-60 minutes. 50 minutes if ultrasound received. 9 total treatment visits, 3 visits per week • One 50-60 minute visit on Monday, Wednesday and Friday, for 3 weeks.
Outcomes
Primary Outcome Measures
Pain Quality Assessment Scale
It is a self-report tool derived from Neuropathic Pain Scale to evaluate the quality of neuropathic pain. After reading the introduction of the questionnaire, subjects will then measure their pain on a numeric scale 0= "no pain" or "no painful sensation" to 10 = "worst imaginable pain sensation" . A zero score represents the best outcome and a 10 is the worst outcome. This questionnaire takes approximately 10 minutes.
Secondary Outcome Measures
Limits of Stability
The LOS test will assess the subjects weight-shifting ability and voluntary limits of stability to eight directional targets set at 100% of theoretical limits of stability for an eight second hold. The LOS test measures five parameters: reaction time, movement velocity, end point excursion, maximum excursion, and directional control. We will take the composite scores of reaction time, movement velocity, end point excursion, maximum excursion, and directional control from the 8 directions. This test should take 10 minutes.
Zeno Walkway
The Zeno Walkway is used to observe the spatiotemporal characteristics of gait in the subjects: velocity and stride length. Participants will be wearing their own shoes and will be instructed prior to arrival to wear comfortable shoes without heels. The subjects will be asked to walk back and forth the walkway 4 times. This test will take 5 minutes.
Sensory organization test (SOT)
The SOT will assess the subject's use of visual, somatosensory, and vestibular systems for maintaining upright posture. The standardized test instructions, per NeuroCom protocol, were either "stand quietly with your eyes open" or "stand quietly with your eyes closed" depending on the condition being tested. This test is completed under six different sensory conditions lasting 20 seconds each.
Step 1 the patient is required to stand still with eyes open (all sensory information available)
Step 2 the patient is required to stand still with their eyes closed
Step 3 the surrounding moves as the patient moves
Step 4 the force plate moves as the patient moves
Step 5 the patient closes their eyes and the force plate moves as the patient moves
Step 6 the surrounding and force plate move as the patient moves This test should take 10 minutes.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04025320
Brief Title
The Effect of Intraneural Facilitation Therapy on Diabetic Patients With Peripheral Neuropathy
Official Title
The Effect of Intraneural Facilitation Therapy on Diabetic Patients With Peripheral Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 27, 2019 (Actual)
Primary Completion Date
December 10, 2020 (Actual)
Study Completion Date
December 10, 2020 (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
The purpose of this graduate student research study is to explore the effects of a new treatment known as Intraneural facilitation (INF) on Diabetes Mellitus Type 2 (DMT2) subjects who have moderate - severe below ankle neuropathy symptoms. Since INF has shown success in the clinic and significant improvements have been found in a recent pilot study, this study aims to further explore these effects on DMT2 subjects suffering from DPN. The investigators would like to investigate if INF improves blood flow in the foot, if it decreases the pain and improves the sensation, and if it improves the overall quality of life.
Detailed Description
The demographic data (age, height, gender, and weight) will be collected from each subject. All subjects will go through the following protocol: First, subjects will complete pre-testing measurements consisting of 5 tests; Pain Quality Assessment Scale, Semmes-Weinstein Monofilaments, NeuroCom SMART Balance Master, Quality of Life- Diabetic Neuropathy Scale (QOL- DN), and Zeno Walkway. Patients will then be randomized into two groups and blinded by the treatment. Patients who draw "Group 1" will be given the INF treatment and patients who draw "Group 2" will be given the SHAM treatment. Patients will then be completing 3 weeks of INF treatment, or SHAM treatment for 3 visits per 3 week, totaling 9 treatment visits. Post treatment, patients will then return for the same 5 measurements completed at baseline.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Intraneural facilitation treatment for 50-60 minutes. 50 minutes if ultrasound received.
9 total treatment visits, 3 visits per week
• One 50-60 minute visit on Monday, Wednesday and Friday, for 3 weeks.
Arm Title
Group 2
Arm Type
Sham Comparator
Arm Description
SHAM treatment for 50-60 minutes. 50 minutes if ultrasound received. 9 total treatment visits, 3 visits per week
• One 50-60 minute visit on Monday, Wednesday and Friday, for 3 weeks.
Intervention Type
Other
Intervention Name(s)
Intraneural Facilitation
Intervention Description
Intraneural Facilitation utilizes three manual holds. Firstly, the contralateral joint is placed in a maximal loose-pack position to pressurize the nervous system and bias circulation from the artery into the epineurium. Now that we have increased this pressure we begin the secondary hold to bias the increased epineurial blood into the transperineurial vessels that bridge the epiperineum and the endoneurial capillaries of the site being treated. Now that the pressure has increased into the open endoneurial capillaries, the goal is to open up ischemic endoneurial capillaries and this is hypothesized to open by providing the third hold. The third hold is known as the sub hold and encourages blood flow through ischemic endoneurial capillaries that have increased resistance/pressure through the application of bernoulli's principle. This treatment will take 50-60 minutes.
Intervention Type
Other
Intervention Name(s)
Sham
Intervention Description
A physical therapist will perform the SHAM light therapy at the same site as the INF therapy location, at the Neuropathic Treatment Center. The SHAM light therapy will last 50-60 minutes and consists of using an anodyne unit for application of near-infrared light therapy. The unit will not be switched on, but the pads will be placed on the subject and the subject will be blinded to the unit being on. The anodyne therapy pads will be placed in the following locations on the affected lower limb: two on the plantar aspect of the foot in a T formation and one pad on the medial and lateral side of the calf. A double folded towel will be wrapped around the subject's foot at the electrode sites to blind the subject's from the light not emitting from the electrodes, due to the anodyne unit being off.
Primary Outcome Measure Information:
Title
Pain Quality Assessment Scale
Description
It is a self-report tool derived from Neuropathic Pain Scale to evaluate the quality of neuropathic pain. After reading the introduction of the questionnaire, subjects will then measure their pain on a numeric scale 0= "no pain" or "no painful sensation" to 10 = "worst imaginable pain sensation" . A zero score represents the best outcome and a 10 is the worst outcome. This questionnaire takes approximately 10 minutes.
Time Frame
change between baseline and 5 weeks
Secondary Outcome Measure Information:
Title
Limits of Stability
Description
The LOS test will assess the subjects weight-shifting ability and voluntary limits of stability to eight directional targets set at 100% of theoretical limits of stability for an eight second hold. The LOS test measures five parameters: reaction time, movement velocity, end point excursion, maximum excursion, and directional control. We will take the composite scores of reaction time, movement velocity, end point excursion, maximum excursion, and directional control from the 8 directions. This test should take 10 minutes.
Time Frame
change between baseline and 5 weeks
Title
Zeno Walkway
Description
The Zeno Walkway is used to observe the spatiotemporal characteristics of gait in the subjects: velocity and stride length. Participants will be wearing their own shoes and will be instructed prior to arrival to wear comfortable shoes without heels. The subjects will be asked to walk back and forth the walkway 4 times. This test will take 5 minutes.
Time Frame
change between baseline and 5 weeks
Title
Sensory organization test (SOT)
Description
The SOT will assess the subject's use of visual, somatosensory, and vestibular systems for maintaining upright posture. The standardized test instructions, per NeuroCom protocol, were either "stand quietly with your eyes open" or "stand quietly with your eyes closed" depending on the condition being tested. This test is completed under six different sensory conditions lasting 20 seconds each.
Step 1 the patient is required to stand still with eyes open (all sensory information available)
Step 2 the patient is required to stand still with their eyes closed
Step 3 the surrounding moves as the patient moves
Step 4 the force plate moves as the patient moves
Step 5 the patient closes their eyes and the force plate moves as the patient moves
Step 6 the surrounding and force plate move as the patient moves This test should take 10 minutes.
Time Frame
change between baseline and 5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with Diabetes Type 2 and Diabetic Peripheral Neuropathy with no other known underlying disease
Below ankle Diabetic Peripheral Neuropathy symptoms (numbness, tingling, burning, sharp pain, increased sensitivity, etc.)
≥10 on Quality of Life- Diabetic Neuropathy Scale (QOL- DN)
Between age 50-75 years
Exclusion Criteria:
Patients with a medical condition that suggested possible decline in function over the next 6 months such as; a current regimen of chemotherapy, radiation therapy, or dialysis
Any lower extremity amputations or wounds
Documented active alcohol and/or drug misuse
Known health conditions: end stage renal failure, uncontrolled hypertension, severe dyslipidemia, chronic liver disease, autoimmune disease, advanced chronic obstructive pulmonary disease and active inflammations
DM patients with inflammatory neuropathies including chronic inflammatory demyelinating polyneuropathy (CIDP), proximal diabetes neuropathy, and autonomic neuropathies
Patients with other types of neuropathies not associated with Diabetes Mellitus such as B12 deficiency, hypothyroidism, and uremia
Other severe chronic medical condition requiring active treatment
Morbidly Obese patients
Pregnancy (self reported)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee Berk, DrPH
Organizational Affiliation
Loma Linda University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35922961
Citation
Sahba K, Berk L, Bussell M, Lohman E, Zamora F, Gharibvand L. Treating peripheral neuropathy in individuals with type 2 diabetes mellitus with intraneural facilitation: a single blind randomized control trial. J Int Med Res. 2022 Aug;50(8):3000605221109390. doi: 10.1177/03000605221109390.
Results Reference
derived
Learn more about this trial
The Effect of Intraneural Facilitation Therapy on Diabetic Patients With Peripheral Neuropathy
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