Effect of Gluten-Free Dietary Education and Intraneural Facilitation® Therapy on Quality of Life in People With Diabetic Neuropathy

NCT05165368 | Completed

• 1 other identifier: 5210345
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Diabetic Neuropathy, Distal Symmetric Polyneuropathy (Manifestation)

Keywords

Intraneural Facilitation® Therapy, Dietary Education, Gluten-free diet, Diabetic Neuropathy

Outcome Measures

Primary Outcomes (3)

• 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.

Secondary Outcomes (5)

• 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.

Study Arms (2)

Intraneural Facilitation® Therapy (INF® Therapy) + Dietary Education

EXPERIMENTAL

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.

Other: Intraneural Facilitation® Therapy (INF® Therapy)

Intraneural Facilitation® Therapy (INF® Therapy)

ACTIVE COMPARATOR

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.

Other: INF® Therapy

Interventions

Intraneural Facilitation® Therapy (INF® Therapy) OTHER

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.

Also known as: INF® Therapy plus Dietary Education

Intraneural Facilitation® Therapy (INF® Therapy) + Dietary Education

INF® Therapy OTHER

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.)

Intraneural Facilitation® Therapy (INF® Therapy)

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants in this study must be/have:
• Older adults between 50 to 75 years of age
• Willing to actively improve neuropathy symptoms
• Diagnosed with Type II diabetes
• Moderate to severe DPN (diabetic peripheral neuropathy) with symptoms below the knees of numbness, tingling, burning, sharp pain, and/or increased sensitivity
• Distal Symmetric Polyneuropathy (DSPN) form of DPN
• Independent in daily activities
• Do not use any assistive device for walking such as a cane, walker, or wheelchair

You may not qualify if:

• Currently consuming a mainly plant-based or gluten-free diet
• Known allergy to chrome, nickel, or cobalt
• Any of the following medical conditions:
• Current regimen of chemotherapy, radiation, or dialysis
• Lower extremity amputations and open wounds
• Documented active drug and/or alcohol misuse
• End stage renal failure
• End stage congestive heart failure
• Uncontrolled hypertension
• Chronic liver disease
• Advanced chronic obstructive pulmonary disease
• Active inflammations
• Other types of neuropathies not associated with diabetes including B12 deficiency
• Any other chronic medical conditions requiring active treatment
• Morbid obesity

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Health

Loma Linda, California, 92350, United States

Location

Related Publications (13)

• Worldwide toll of diabetes. Accessed January 20, 2020. https://www.diabetesatlas.org/en/sections/worldwide-toll-of-diabetes.html

  BACKGROUND

• Cumulative confirmed COVID-19 deaths. Our World in Data. Accessed February 18, 2021. https://ourworldindata.org/grapher/cumulative-covid-deaths-region

  BACKGROUND

• 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.

  PMID: 31197153 BACKGROUND

• 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.

  PMID: 26808781 BACKGROUND

• Bussell M. Neuropathic Treatment with Intraneural Facilitation. Presented at the: January 10, 2017. https://1drv.ms/p/s!AnT8e3KAvXUxgYc3Jf2Qkqu6HQb0lA?e=lHOOxP

  BACKGROUND

• 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

  BACKGROUND

• Advocate | American Nutrition Association. Accessed November 13, 2020. https://theana.org/advocate

  BACKGROUND

• 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.

  PMID: 35922961 BACKGROUND

• 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.

  PMID: 30032386 BACKGROUND

• 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.

  PMID: 20170845 BACKGROUND

• 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.

  PMID: 14747475 BACKGROUND

• 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.

  PMID: 17074624 BACKGROUND

• 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.

  PMID: 9040716 BACKGROUND

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Eric G Johnson, DSc, MS-HPEd

  Department of Physical Therapy School of Allied Health Professions, Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator and outcomes assessor will be blinded to interventional group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Using the block randomization method, patients will be randomly assigned to the INF® Therapy only group or the INF® Therapy+ group. Ten participants will be recruited at a time with 5 randomly assigned to each group.

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 21, 2021
• Study Start: August 1, 2023
• Primary Completion: May 20, 2025
• Study Completion: May 20, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)