A Physiologic Comparison of Two Approaches to Treating Peripheral Neuropathy
NCT ID: NCT05577390
Last Updated: 2025-11-19
Study Results
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Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2024-01-08
2027-08-01
Brief Summary
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Detailed Description
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During the participants first and eleventh sessions participants will complete the Pain Quality Assessment Scale (PQAS), the Lower Extremity Neuropathy Scale (LENS), a vascular analysis of the Neurovascular Index (NVI) using a Philips Affinity 50 Ultrasound, and Neuropad® testing. The first session will also include completion of the Background Information form. Patients will be asked to wear loose fitting clothing and to arrive 15 minutes early to complete the informed consent documents on the first session.
Welltory App measurements to assess heart rate variability will be taken in the morning and evening the day before, the day of, and the day after each treatment session.
On the second session the patient will have:
* Electrocardiogram testing (ECG) for assessment of heart rate variability (HRV) using PowerLab+LabChart and BioAmp (AD Instruments, Colorado Springs, CO).
* Near-infrared Spectroscopy (NIRS) measurement using a Foresight Elite monitor (Edwards LifeSciences, Irvine, CA)
* Laser Doppler flowmetry (LDF) measurement using a skin surface Laser Doppler add-on for Chart/Powerlab (AD Instruments, Colorado Springs, CO).
* Welltory App measurements will be taken before and after treatment to assess for heart rate variability (HRV).
* A blood draw will be completed by a licensed lab technician to measure blood cytokine and HbA1C levels. A total of 1 1/3 teaspoons of blood will collected at this time point. The blood draw will be performed prior to treatment.
* The patient will then receive a 60 minute INF® Therapy or standard physical therapy session.
* The aforementioned tests will then be repeated including ECG, NIRS, and LDF to measure post treatment values.
During the third, fourth, sixth, seventh, eighth, and ninth sessions, the patient will have a 60 minute INF® Therapy or standard physical therapy session. Welltory App measurements will be taken before and after treatment to assess for heart rate variability (HRV).
On the fifth session the patient will have a 60 minute INF® Therapy or standard physical therapy session. Welltory App measurements will be taken before and after treatment to assess for heart rate variability (HRV). Followed by:
• A blood draw by a licensed lab technician to measure blood cytokine levels. A total of 1 ¼ teaspoons will be collected at this time point.
On the tenth session the patient will have a 60 minute INF® Therapy or standard physical therapy session. Welltory App measurements will be taken before and after treatment to assess for heart rate variability (HRV). Followed by:
* Electrocardiogram testing (ECG) for assessment of heart rate variability (HRV) using PowerLab+LabChart and BioAmp (AD Instruments, Colorado Springs, CO).
* Near-infrared Spectroscopy (NIRS) using a Foresight Elite monitor (Edwards LifeSciences, Irvine, CA)
* Laser Doppler flowmetry (LDF) measurement using a skin surface Laser Doppler add-on for Chart/PowerLab (AD Instruments, Colorado Springs, CO).
* A blood draw will be completed by licensed lab technician to measure blood cytokine levels and HbA1C. A total of 1 1/3 teaspoons will be collected at this time point.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intraneural Facilitation Therapy Treatment Group
Subjects will receive nine 60-minute INF® Therapy Treatments during sessions 2 through 10. INF® Therapy is a non-invasive treatment that helps eliminate pain, tingling, numbness, and other symptoms that come with neuropathy.
Intraneural Facilitation Therapy Treatment
Intraneural Facilitation Therapy uses three manual holds to bias blood flow to closed endoneurial capillaries. The first is the facilitation hold, which is thought to pressurize the nervous system and bias circulation from the artery into the epineurium. This hold stretches the nerve further than the artery, increasing the amount of elastin in the artery and enlarging the opening of the arterial junction increasing blood into the epineurium. The secondary hold then increases epineurial blood into the transperineurial vessels increasing pressure into the endoneurial capillaries of the site being treated. The third hold, known as the sub hold, encourages blood flow through ischemic endoneurial capillaries that have increased resistance/pressure through the application of Bernoulli's principle. The series of stretches will be repeated on the affected side for the treatment duration.
Standard Physical Therapy Treatment Group
Subjects will receive nine 60-minute standard physical therapy treatments during sessions 2 through 10.
Standard Physical Therapy Treatment
The standard physical therapy treatment includes muscle stretching, balance, and strengthening exercises known to improve neuropathy symptoms.
Interventions
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Intraneural Facilitation Therapy Treatment
Intraneural Facilitation Therapy uses three manual holds to bias blood flow to closed endoneurial capillaries. The first is the facilitation hold, which is thought to pressurize the nervous system and bias circulation from the artery into the epineurium. This hold stretches the nerve further than the artery, increasing the amount of elastin in the artery and enlarging the opening of the arterial junction increasing blood into the epineurium. The secondary hold then increases epineurial blood into the transperineurial vessels increasing pressure into the endoneurial capillaries of the site being treated. The third hold, known as the sub hold, encourages blood flow through ischemic endoneurial capillaries that have increased resistance/pressure through the application of Bernoulli's principle. The series of stretches will be repeated on the affected side for the treatment duration.
Standard Physical Therapy Treatment
The standard physical therapy treatment includes muscle stretching, balance, and strengthening exercises known to improve neuropathy symptoms.
Eligibility Criteria
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Inclusion Criteria
* Moderate to severe type II diabetic neuropathy with one or more symptoms including: numbness, tingling, burning, sharp pain, and/or increased sensitivity.
* Diagnosis confirmed by a physician.
* Cellphone access with Android 5.0 and up or iOS 14.0 or later.
Exclusion Criteria
* Chemotherapy
* Radiation
* Lower extremity amputations
* Open wounds
* Documented active drug and or alcohol misuse
* Chronic liver disease
* Active inflammations
* Other types of neuropathies not associated with diabetes including B12 deficiency and Charcot Marie Tooth
* Morbid obesity
* Pregnancy.
* Taking beta blockers
* Unable to maintain steady fingers or operate a cellphone
* Smoking or ingesting marijuana
* Having a pacemaker
* Allergies to cobalt, chrome, or nickel
45 Years
85 Years
ALL
No
Sponsors
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Loma Linda University
OTHER
Responsible Party
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Principal Investigators
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Mark Bussell, DPT, OCS
Role: PRINCIPAL_INVESTIGATOR
Loma Linda University Health
Locations
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Loma Linda University Health Neuropathic Therapy Center
Loma Linda, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. No abstract available.
Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, Shaw JE, Bright D, Williams R; IDF Diabetes Atlas Committee. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019 Nov;157:107843. doi: 10.1016/j.diabres.2019.107843. Epub 2019 Sep 10.
Feldman EL, Callaghan BC, Pop-Busui R, Zochodne DW, Wright DE, Bennett DL, Bril V, Russell JW, Viswanathan V. Diabetic neuropathy. Nat Rev Dis Primers. 2019 Jun 13;5(1):41. doi: 10.1038/s41572-019-0092-1.
Gordois A, Scuffham P, Shearer A, Oglesby A, Tobian JA. The health care costs of diabetic peripheral neuropathy in the US. Diabetes Care. 2003 Jun;26(6):1790-5. doi: 10.2337/diacare.26.6.1790.
Gore M, Brandenburg NA, Dukes E, Hoffman DL, Tai KS, Stacey B. Pain severity in diabetic peripheral neuropathy is associated with patient functioning, symptom levels of anxiety and depression, and sleep. J Pain Symptom Manage. 2005 Oct;30(4):374-85. doi: 10.1016/j.jpainsymman.2005.04.009.
Hicks CW, Selvin E. Epidemiology of Peripheral Neuropathy and Lower Extremity Disease in Diabetes. Curr Diab Rep. 2019 Aug 27;19(10):86. doi: 10.1007/s11892-019-1212-8.
Callaghan BC, Gallagher G, Fridman V, Feldman EL. Diabetic neuropathy: what does the future hold? Diabetologia. 2020 May;63(5):891-897. doi: 10.1007/s00125-020-05085-9. Epub 2020 Jan 23.
Alshahrani A, Bussell M, Johnson E, Tsao B, Bahjri K. Effects of a Novel Therapeutic Intervention in Patients With Diabetic Peripheral Neuropathy. Arch Phys Med Rehabil. 2016 May;97(5):733-8. doi: 10.1016/j.apmr.2015.12.026. Epub 2016 Jan 22.
Sun PC, Kuo CD, Chi LY, Lin HD, Wei SH, Chen CS. Microcirculatory vasomotor changes are associated with severity of peripheral neuropathy in patients with type 2 diabetes. Diab Vasc Dis Res. 2013 May;10(3):270-6. doi: 10.1177/1479164112465443. Epub 2012 Dec 14.
Zheng H, Sun W, Zhang Q, Zhang Y, Ji L, Liu X, Zhu X, Ye H, Xiong Q, Li Y, Lu B, Zhang S. Proinflammatory cytokines predict the incidence of diabetic peripheral neuropathy over 5 years in Chinese type 2 diabetes patients: A prospective cohort study. EClinicalMedicine. 2020 Dec 23;31:100649. doi: 10.1016/j.eclinm.2020.100649. eCollection 2021 Jan.
Lockhart CJ, McCann AJ, Pinnock RA, Hamilton PK, Harbinson MT, McVeigh GE. Multimodal functional and anatomic imaging identifies preclinical microvascular abnormalities in type 1 diabetes mellitus. Am J Physiol Heart Circ Physiol. 2014 Dec 15;307(12):H1729-36. doi: 10.1152/ajpheart.00372.2014. Epub 2014 Oct 3.
McVeigh GE, Morgan DR, Allen P, Trimble M, Hamilton P, Dixon LJ, Silke B, Hayes JR. Early vascular abnormalities and de novo nitrate tolerance in diabetes mellitus. Diabetes Obes Metab. 2002 Sep;4(5):336-41. doi: 10.1046/j.1463-1326.2002.00220.x.
Selvarajah D, Wilkinson ID, Fang F, Sankar A, Davies J, Boland E, Harding J, Rao G, Gandhi R, Tracey I, Tesfaye S. Structural and Functional Abnormalities of the Primary Somatosensory Cortex in Diabetic Peripheral Neuropathy: A Multimodal MRI Study. Diabetes. 2019 Apr;68(4):796-806. doi: 10.2337/db18-0509. Epub 2019 Jan 7.
Vinik AI, Maser RE, Mitchell BD, Freeman R. Diabetic autonomic neuropathy. Diabetes Care. 2003 May;26(5):1553-79. doi: 10.2337/diacare.26.5.1553.
Pop-Busui R, Backlund JC, Bebu I, Braffett BH, Lorenzi G, White NH, Lachin JM, Soliman EZ; DCCT/EDIC Research Group. Utility of using electrocardiogram measures of heart rate variability as a measure of cardiovascular autonomic neuropathy in type 1 diabetes patients. J Diabetes Investig. 2022 Jan;13(1):125-133. doi: 10.1111/jdi.13635. Epub 2021 Aug 14.
Iannetta D, Inglis EC, Soares RN, McLay KM, Pogliaghi S, Murias JM; CAPES scholarship holder. Reliability of microvascular responsiveness measures derived from near-infrared spectroscopy across a variety of ischemic periods in young and older individuals. Microvasc Res. 2019 Mar;122:117-124. doi: 10.1016/j.mvr.2018.10.001. Epub 2018 Oct 4.
Brown CD, Davis HT, Ediger MN, Fleming CM, Hull EL, Rohrscheib M. Clinical assessment of near-infrared spectroscopy for noninvasive diabetes screening. Diabetes Technol Ther. 2005 Jun;7(3):456-66. doi: 10.1089/dia.2005.7.456.
Other Identifiers
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5220363
Identifier Type: -
Identifier Source: org_study_id
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