4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / The Effect of Intraneural Facilitation Therapy on Diabetic Patients With Peripheral Neuropathy

The Effect of Intraneural Facilitation Therapy on Diabetic Patients With Peripheral Neuropathy

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.

Condition or disease Intervention/treatment Phase
Diabetic Neuropathy Other: Intraneural Facilitation Other: Sham Not Applicable

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of Intraneural Facilitation Therapy on Diabetic Patients With Peripheral Neuropathy
Actual Study Start Date : September 27, 2019
Actual Primary Completion Date : December 10, 2020
Actual Study Completion Date : December 10, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Group 1

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.

Other: Intraneural Facilitation
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.

Sham Comparator: Group 2

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.

Other: Sham
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.

Outcome Measures
Primary Outcome Measures :
  1. Pain Quality Assessment Scale [ Time Frame: change between baseline and 5 weeks ]
    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 :
  1. Limits of Stability [ Time Frame: change between baseline and 5 weeks ]
    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.

  2. Zeno Walkway [ Time Frame: change between baseline and 5 weeks ]
    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.

  3. Sensory organization test (SOT) [ Time Frame: change between baseline and 5 weeks ]

    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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations

Locations
Layout table for location information
United States, California
Loma Linda University
Loma Linda, California, United States, 92350
Sponsors and Collaborators
Loma Linda University
Investigators
Layout table for investigator information
Principal Investigator: Lee Berk, DrPH Loma Linda University
Tracking Information
First Submitted Date  ICMJE June 11, 2019
First Posted Date  ICMJE July 18, 2019
Last Update Posted Date May 17, 2021
Actual Study Start Date  ICMJE September 27, 2019
Actual Primary Completion Date December 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2019)
Pain Quality Assessment Scale [ Time Frame: change between baseline and 5 weeks ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2019)
  • Limits of Stability [ Time Frame: change between baseline and 5 weeks ]
    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 [ Time Frame: change between baseline and 5 weeks ]
    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) [ Time Frame: change between baseline and 5 weeks ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Intraneural Facilitation Therapy on Diabetic Patients With Peripheral Neuropathy
Official Title  ICMJE The Effect of Intraneural Facilitation Therapy on Diabetic Patients With Peripheral Neuropathy
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Neuropathy
Intervention  ICMJE
  • Other: Intraneural Facilitation
    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.
  • Other: Sham
    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.
Study Arms  ICMJE
  • Experimental: Group 1

    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.

    Intervention: Other: Intraneural Facilitation
  • Sham Comparator: Group 2

    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: Other: Sham
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 13, 2021)
30
Original Estimated Enrollment  ICMJE
 (submitted: July 16, 2019)
48
Actual Study Completion Date  ICMJE December 10, 2020
Actual Primary Completion Date December 10, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04025320
Other Study ID Numbers  ICMJE 5190128
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lee Berk, Loma Linda University
Study Sponsor  ICMJE Loma Linda University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lee Berk, DrPH Loma Linda University
PRS Account Loma Linda University
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP