NCT05165368|Completed
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Sponsor study identifier
interventional
46
1 country
1
Study Start
August 1, 2023
Actual (reported)Primary Completion
May 20, 2025
Actual (reported)Study Completion
May 20, 2025
Actual (reported)The purpose of this research is to compare the effectiveness of providing dietary education to complement Intraneural Facilitation® Therapy (INF® Therapy) (a physical therapy technique being evaluated that may help improve circulation) versus INF® Therapy only in adults with a type of neuropathy called distal symmetric polyneuropathy (DSPN).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 20, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 8, 2021
Actual (reported)December 21, 2021
Actual (reported)August 1, 2023
Actual (reported)May 20, 2025
Actual (reported)May 20, 2025
Actual (reported)Neuropathy Severity
The Neuropad® test measures sweat production as an indicator for peripheral neuropathy severity in people with type 2 diabetes. Sudometrics image analysis software will be utilized to analyze Neuropad® time to color change since it produces continuous outputs to quantify neuropathic severity.
Change between baseline and 3 Months post enrollment.
Balance Stability
Mini balance evaluation system test (Mini-BESTest) assesses 4 balance-related subcategories of anticipatory, reactive postural control, sensory orientation, and dynamic gait, and takes approximately 15 minutes to administer.
Change between baseline and 3 Months post enrollment.
Pain Intensity Level
The visual analog scale (VAS) for pain is a subjective measure of pain intensity.
Change between baseline and 3 Months post enrollment.
Gluten Consumption Assessment
Change between baseline and 3 Months post enrollment.
Sleep Quality Assessment
Change between baseline and 3 Months post enrollment.
Total Weekly Physical Activity
Change between baseline and 3 Months post enrollment.
State-Trait Anxiety Level
Change between baseline and 3 Months post enrollment.
Pain Quality Assessment
Change between baseline and 3 Months post enrollment.
The INF® Therapy+ group will receive dietary education with weekly follow-up by a physical therapist either in person, or via email or text message. The INF® Therapy+ group will additionally receive meal preparation ideas and sample menus promoting a gluten-free diet.
INF® Therapy is a manual therapy technique that consists of three components. The first is the pressurization or facilitation hold which biases circulation more consistently in the nerves, which is thought to "pressurize the entire system" The secondary hold attempts to stretch the innervated structure, pulling apart the tough dividing membrane and allowing the pressurized blood flow to transport from the outside "holding" chamber to the endoneurium and push open the closed capillary beds next to the nerve axons. Once capillaries surrounding the nerves are pressurized, the circulation needs to be induced up the neural connective tissue. A separate set of pressure points or "holds" are performed distal to the secondary holds to ensure the circulation is drawn up the inflamed capillary beds using the Bernoulli principle.
INF® Therapy plus dietary education with weekly follow-up by a physical therapist. Includes meal preparation ideas and sample menus promoting a gluten-free diet.
INF® Therapy only (INF® Therapy is a manual therapy technique that consists of three components. The first is the pressurization or facilitation hold which biases circulation more consistently in the nerves, which is thought to "pressurize the entire system" The secondary hold attempts to stretch the innervated structure, pulling apart the tough dividing membrane and allowing the pressurized blood flow to transport from the outside "holding" chamber to the endoneurium and push open the closed capillary beds next to the nerve axons. Once capillaries surrounding the nerves are pressurized, the circulation needs to be induced up the neural connective tissue. A separate set of pressure points or "holds" are performed distal to the secondary holds to ensure the circulation is drawn up the inflamed capillary beds using the Bernoulli principle.)
Loma Linda University Health
Loma Linda, California, 92350, United States
Worldwide toll of diabetes. Accessed January 20, 2020. https://www.diabetesatlas.org/en/sections/worldwide-toll-of-diabetes.html
Cumulative confirmed COVID-19 deaths. Our World in Data. Accessed February 18, 2021. https://ourworldindata.org/grapher/cumulative-covid-deaths-region
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.
Eric G Johnson, DSc, MS-HPEd
Department of Physical Therapy School of Allied Health Professions, Loma Linda University
46 participants (actual enrollment reported by the registry).
First Submitted
December 8, 2021
First Posted
December 21, 2021
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
Bussell M. Neuropathic Treatment with Intraneural Facilitation. Presented at the: January 10, 2017. https://1drv.ms/p/s!AnT8e3KAvXUxgYc3Jf2Qkqu6HQb0lA?e=lHOOxP
Role Of PT Diet Nutrition. APTA. Published September 20, 2019. Accessed November 13, 2020. https://www.apta.org/apta-and-you/leadership-and-governance/policies/role-of-pt-diet-nutrition
Advocate | American Nutrition Association. Accessed November 13, 2020. https://theana.org/advocate
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.
Zis P, Sarrigiannis PG, Rao DG, Hadjivassiliou M. Gluten neuropathy: prevalence of neuropathic pain and the role of gluten-free diet. J Neurol. 2018 Oct;265(10):2231-2236. doi: 10.1007/s00415-018-8978-5. Epub 2018 Jul 21.
Hadjivassiliou M, Sanders DS, Grunewald RA, Woodroofe N, Boscolo S, Aeschlimann D. Gluten sensitivity: from gut to brain. Lancet Neurol. 2010 Mar;9(3):318-30. doi: 10.1016/S1474-4422(09)70290-X.
Fleckenstein B, Qiao SW, Larsen MR, Jung G, Roepstorff P, Sollid LM. Molecular characterization of covalent complexes between tissue transglutaminase and gliadin peptides. J Biol Chem. 2004 Apr 23;279(17):17607-16. doi: 10.1074/jbc.M310198200. Epub 2004 Jan 27.
Jensen MP, Gammaitoni AR, Olaleye DO, Oleka N, Nalamachu SR, Galer BS. The pain quality assessment scale: assessment of pain quality in carpal tunnel syndrome. J Pain. 2006 Nov;7(11):823-32. doi: 10.1016/j.jpain.2006.04.003.
Galer BS, Jensen MP. Development and preliminary validation of a pain measure specific to neuropathic pain: the Neuropathic Pain Scale. Neurology. 1997 Feb;48(2):332-8. doi: 10.1212/wnl.48.2.332.
Study Start
August 1, 2023
Actual (reported)Primary Completion
May 20, 2025
Actual (reported)Study Completion
May 20, 2025
Actual (reported)Last Updated
August 14, 2025
Record last verified: 2025-08
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