Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetic Neuropathy | Other: Intraneural Facilitation Other: Sham | Not Applicable |
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 |
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.
|
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.
Ages Eligible for Study: | 50 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Loma Linda University | |
Loma Linda, California, United States, 92350 |
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 |
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 |
|
||||
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 |
|
||||
Study Arms ICMJE |
|
||||
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 |
30 | ||||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
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 |
|
||||
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 |
|
||||
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 |