Effect of Dietary Education on Intraneural Facilitation™ Neuropathy Therapy
Study Details
Study Description
Brief Summary
The purpose of this research is to compare the effectiveness of providing dietary education to complement Intraneural Facilitation™ (INF) (a physical therapy technique being evaluated that may help improve circulation) versus INF only in adults with a type of neuropathy called distal symmetric polyneuropathy (DSPN).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
[All participants] First assessment session: Before starting the procedures, the participants who are uninterested in improving their neuropathy symptoms will be excluded from the study. The lack of interest in improving neuropathy symptoms may negatively affect participants motivation to make dietary changes and hence may negatively affect their compliance rate. Following completion of the signing procedures, using the block randomization method, patients will be randomly assigned to the INF only group or the INF+ group. Ten participants will be recruited at a time with 5 randomly assigned to each group. Then all participants will be given brief explanations before administration of the questionnaires.
Participants will first be instructed to complete the visual analog scale (VAS) for pain, a subjective measure of pain intensity consisting of a 10 centimeter (cm) line with anchor statements on the left (no pain) and extreme pain on the right. Pain scores will be determined by measuring the distance in cm from "no pain" to the participant's anchor point.
Next, participants will complete a series of self-report questionnaires beginning with the Modified Segal-Issacson Rapid Eating Assessment for Participants-Shortened Version (REAP-S) which assesses frequency and portions consumed of restaurant food, gluten, dairy, meat, sweets, processed foods, fruits, and vegetables. In addition, the questionnaire includes questions pertaining to motivation to change and social and health barriers to at home meal preparation.
Next, the PSQI is a clinical questionnaire assessing quality of sleep and sleep disturbances over the past month. The 19-item questionnaire provides seven component scores assessing subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medications, and daytime dysfunction.
Further, the IPAQ-S measures intensity of physical activity and sitting time to estimate total physical activity per week. Computation of the total score for the short form requires summation of the duration (in minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activities.
Finally, participants will complete the STAI-form Y which is a definitive clinical measure of state and trait anxiety in adults. Form Y has 20 items for assessing trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.
Participants who are currently consuming a mainly plant-based or gluten-free diet, or have a known allergy to chrome, nickel, or cobalt will be excluded from the study.
All participants will be familiarized to the Neuropad® test and MiniBESTest prior to taking measurements. The Neuropad® test measures sweat production as an indicator for peripheral neuropathy severity in people with type 2 diabetes. The time for the cobalt (II) chloride indicator to complete color change from blue to pink is correlated to severity of nerve conduction impairment: 892±179 seconds in severe nerve conduction impairment, and 1983±386 in those with moderate nerve conduction impairment (P =.01). Sudometrics image analysis software will be utilized to analyze Neuropad® time to color change since it produces continuous outputs to quantify neuropathic severity.
Next, participants will perform mini balance evaluation system test (Mini-BESTest) which contains 14 tasks under 4 balance-related subcategories of anticipatory (3 items), reactive postural control (3 items), sensory orientation (3 items), and dynamic gait (5 items), and takes approximately 15 minutes to administer. Each item is scored from 0 (unable) to 2 (normal) with a maximum score of 28.
[For INF+ group only: The INF+ group will receive verbal dietary education with weekly follow-up by a physical therapist either in person, via email, or over the phone. The INF+ group will additionally receive meal preparation ideas and sample menus via email from the T. Collin Campbell Center for Nutrition Studies which promotes a whole plant foods lifestyle.] [All participants] Second assessment session (visit 12): Participants will return the week after completion of the ten INF therapy sessions for immediate post-intervention measurements. Participants will have opportunity to ask any questions they may have. For the INF+ group, participants will be reminded to continue with dietary changes and follow up each week using the mREAPS form.
[Only for participants in the INF+ group: Participants will be contacted weekly by e-mail or phone call to facilitate compliance with the dietary changes. A weekly dietary compliance questionnaire will be completed based on each week's mREAPS questionnaire responses. The evaluator (PT not involved in other participant assessments) will document the date and participant's ID on the first two lines. Next, the evaluator will either assist participant in completing or review the modified REAP-S questionnaire that the participant will be instructed to complete prior to the appointment each week.
The evaluator will then calculate dietary compliance based on the data entered on the dietary recall mREAPS forms, subtracting one to three points from ten possible points for every instance of meat, poultry, fish, eggs, or other dairy consumption. For modified REAP-S questionnaire items 6, 7, 8 answers of "sometimes" = subtract 1 point, "often" = subtract 2 points, "usually" = subtract 3 points. For example, a participant who answers "usually" for all three items would receive a cumulative score of 1/10 (-3x3 items = -9 points). Finally, the evaluator will document dietary education provided (yes/no) and barriers to change (yes/no) along with brief comments/summary of topics discussed with participant.
In order to accurately assess consistency, it may be ideal to randomly call participants by phone (with prior permission) each week to complete the modified REAP-S questionnaire.] [All participants] Final assessment session (visit 13): At the end of three months post-INF completion, participants will return for post-intervention measurements. The post-intervention measurements will include Neuropad® neuropathy severity measure, MiniBESTest functional balance assessment, visual analog scale (VAS) for pain, modified Segal-Issacson Rapid Eating Assessment for Participants-Shortened Version (REAP-S) questionnaire, self-reported adherence to dietary changes questionnaire, the Pittsburg Sleep Quality Index (PSQI), International Physical Activity Questionnaire-short form (IPAQ-S), and State-Trait Anxiety Inventory Form Y (STAI-form Y).
After the three-month retesting, if a statistically significant difference emerges in the final analysis, then the INF only group will be provided with the same dietary education materials the INF+ group received.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intraneural Facilitation (INF) + Dietary Education The INF+ group will receive dietary education reviewed by a physician with weekly follow-up by a physical therapist either in person, or via email. The INF+ group will additionally receive meal preparation ideas and sample menus promoting a whole plant foods lifestyle. |
Other: Intraneural Facilitation (INF)
INF plus dietary education reviewed by a physician with weekly follow-up by a physical therapist. Includes meal preparation ideas and sample menus promoting a whole plant foods lifestyle.
Other Names:
|
| Active Comparator: Intraneural Facilitation (INF) INF™ 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
INF only (INF™ 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.)
|
Outcome Measures
Primary Outcome Measures
- Neuropathy Severity [Change between baseline and 3 Months post enrollment.]
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.
- Balance Stability [Change between baseline and 3 Months post enrollment.]
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.
- Pain Intensity Level [Change between baseline and 3 Months post enrollment.]
The visual analog scale (VAS) for pain is a subjective measure of pain intensity.
Secondary Outcome Measures
- Food Type Distribution [Change between baseline and 3 Months post enrollment.]
Modified Segal-Issacson Rapid Eating Assessment for Participants-Shortened Version (REAP-S) assesses frequency and portions consumed of restaurant food, gluten, dairy, meat, sweets, processed foods, fruits, and vegetables. In addition, the questionnaire includes questions pertaining to motivation to change and social and health barriers to at home meal preparation.
- Sleep Quality Assessment [Change between baseline and 3 Months post enrollment.]
The PSQI is a clinical questionnaire assessing quality of sleep and sleep disturbances over the past month. The questionnaire provides seven component scores assessing subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medications, and daytime dysfunction.
- Total Weekly Physical Activity [Change between baseline and 3 Months post enrollment.]
The IPAQ-S measures intensity of physical activity and sitting time to estimate total physical activity per week.
- State-Trait Anxiety Level [Change between baseline and 3 Months post enrollment.]
The STAI-form Y which is a definitive clinical measure of state and trait anxiety in adults.
Eligibility Criteria
Criteria
Inclusion Criteria
Participants in this study must be/have:
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Older adults between 50 to 75 years of age
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Willing to actively improve neuropathy symptoms
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Diagnosed with Type II diabetes
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Moderate to severe DPN (diabetic peripheral neuropathy) with symptoms below the knees of numbness, tingling, burning, sharp pain, and/or increased sensitivity
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Distal Symmetric Polyneuropathy (DSPN) form of DPN confirmed by a physician
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Independent in daily activities
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Do not use any assistive device for walking such as a cane, walker, or wheelchair
Exclusion Criteria
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Currently consuming a mainly plant-based or gluten-free diet
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Known allergy to chrome, nickel, or cobalt
Any of the following medical conditions:
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Current regimen of chemotherapy, radiation, or dialysis
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Lower extremity amputations and open wounds
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Documented active drug and/or alcohol misuse
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End stage renal failure
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End stage congestive heart failure
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Uncontrolled hypertension
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Chronic liver disease
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Advanced chronic obstructive pulmonary disease
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Active inflammations
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Other types of neuropathies not associated with diabetes including B12 deficiency
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Any other chronic medical conditions requiring active treatment
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Morbid obesity
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Pregnancy (self-reported)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Loma Linda University
Investigators
- Principal Investigator: Eric G Johnson, DSc, MS-HPEd, Department of Physical Therapy School of Allied Health Professions, Loma Linda University
Study Documents (Full-Text)
None provided.More Information
Publications
- Advocate | American Nutrition Association. Accessed November 13, 2020. https://theana.org/advocate
- 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.
- Brandsma E, Houben T, Fu J, Shiri-Sverdlov R, Hofker MH. The immunity-diet-microbiota axis in the development of metabolic syndrome. Curr Opin Lipidol. 2015 Apr;26(2):73-81. doi: 10.1097/MOL.0000000000000154. Review.
- Bussell M. Neuropathic Treatment with Intraneural Facilitation. Presented at the: January 10, 2017. https://1drv.ms/p/s!AnT8e3KAvXUxgYc3Jf2Qkqu6HQb0lA?e=lHOOxP
- 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. Review.
- McMacken M, Shah S. A plant-based diet for the prevention and treatment of type 2 diabetes. J Geriatr Cardiol. 2017 May;14(5):342-354. doi: 10.11909/j.issn.1671-5411.2017.05.009. Review.
- 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
- Stanhope KL. Sugar consumption, metabolic disease and obesity: The state of the controversy. Crit Rev Clin Lab Sci. 2016;53(1):52-67. doi: 10.3109/10408363.2015.1084990. Epub 2015 Sep 17. Review.
- Worldwide toll of diabetes. Accessed January 20, 2020. https://www.diabetesatlas.org/en/sections/worldwide-toll-of-diabetes.html
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