Effect of Diet on Neuropathic Pain After Spinal Cord Injury

Sponsor
Lawson Health Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT04271904
Collaborator
Ontario Neurotrauma Foundation (Other)
22
1
3
20
1.1

Study Details

Study Description

Brief Summary

This pilot study will evaluate the effects of a placebo diet vs an anti-inflammatory diet in individuals with spinal cord injury. It is being performed to ensure that the placebo diet does not also induce reductions in inflammation and also adequately conceals group allocation.

Condition or Disease Intervention/Treatment Phase
  • Other: Anti-inflammatory Diet
  • Other: Placebo Diet
N/A

Detailed Description

Anti-inflammatory diet is a novel treatment that may be beneficial for managing neuropathic pain (NP) after Spinal Cord Injury (SCI). NP is a common complication following SCI that significantly decreases quality of life. Treatment options are limited, and current treatments can have significant side effects. Those with SCI have identified a need for additional treatment options, particularly those that are not medications.

As pain is a subjective outcome, awareness of group allocation could influence treatment expectations and participant rated scores of neuropathic pain. It is therefore important to ensure that an adequate placebo intervention is utilized. This pilot study will assess whether the placebo diet to be used in an upcoming RCT provides sufficient group allocation concealment (i.e. ensure participants are unaware of whether they are on the anti-inflammatory diet or placebo diet). This pilot study will also assess whether the placebo diet is in fact inflammation neutral (ie. induces no reductions in inflammation).

Study Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Eligible participants who consent to study participation will be randomized to one of three groups: anti-inflammatory diet, placebo diet, or non-dieting control. Those on the anti-inflammatory diet or placebo diet will be given respective meal plans and recipes while the non-dieting control group will be asked to continue eating as usual. Interventions will run for 4-week period.Eligible participants who consent to study participation will be randomized to one of three groups: anti-inflammatory diet, placebo diet, or non-dieting control. Those on the anti-inflammatory diet or placebo diet will be given respective meal plans and recipes while the non-dieting control group will be asked to continue eating as usual. Interventions will run for 4-week period.
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
No other parties will be masked for the study.
Primary Purpose:
Treatment
Official Title:
Anti-inflammatory Diet for the Treatment of Neuropathic Pain After Spinal Cord Injury: A Pilot Study
Actual Study Start Date :
Oct 1, 2020
Actual Primary Completion Date :
Jun 3, 2022
Actual Study Completion Date :
Jun 3, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Anti-inflammatory Diet

Those on the anti-inflammatory diet will be given a meal plan and recipes to be followed at home after consultation with the study dietitian. In brief, this meal plan will eliminate foods that have been established as pro-inflammatory (e.g. processed foods, refined sugars, refined wheat products, etc.) as well as foods that are commonly associated with even mild intolerances (e.g. cow's milk) and those that negatively impact cardiovascular health (e.g. hydrogenated oils, refined sugars and wheat, etc.). In their place, the meal plan will consist of foods with established anti-inflammatory properties (e.g. (Oily fish, lean poultry, dark leafy greens, etc.). Participants will also be given a list of foods that they are allowed on the anti-inflammatory diet, and a list of foods to avoid so that they can make informed substitutions to the meals and ingredients that they are given. The study participants will be given a one-week meal plan with accompanying recipes.

Other: Anti-inflammatory Diet
Participants will be given a list of foods that they are allowed on the anti-inflammatory diet, and a list of foods to avoid so that they can make informed substitutions to the meals and ingredients that they are given. The study participants will be given a one-week meal plan with accompanying recipes. Occasional "cheat" foods are built into the anti-inflammatory diet (e.g. two bottles of beer per week)

Placebo Comparator: Placebo Diet

Participants on the placebo diet will be given a meal plan and recipes by the study dietitian. The dietitian will assist in developing a diet that is isocaloric to the anti-inflammatory diet and healthy (for the sake of the participants' well-being, and to blind participants), while allowing many foods that are (counterintuitively) pro-inflammatory (e.g. whole wheat bread, white beans, oats, soy, eggplant, raspberries, pumpkin seeds, popcorn, etc). There are many counter-intuitive restrictions in the anti-inflammatory diet that we will be using (banned foods include white beans, soy, eggplant, oats, raspberries, strawberries, prunes, walnuts, cashews, soy milk. Allowed foods include maple syrup, honey, lean beef, lamb, brown rice, feta cheese, butter). Therefore, even fairly astute and educated participants may have trouble discerning which diet they are consuming (anti-inflammatory or placebo).

Other: Placebo Diet
The dietitian will assist in developing a diet that is isocaloric to the anti-inflammatory diet and healthy (for the sake of the participants' well-being, and to blind participants), while allowing many foods that are (counterintuitively) pro-inflammatory (e.g. whole wheat bread, white beans, oats, soy, eggplant, raspberries, pumpkin seeds, popcorn, etc). Occasional "cheat" foods are built into the placebo diet but with more pro-inflammatory options (e.g. two glasses of wine per week).

No Intervention: Non-dieting Control

Those in the non-dieting control condition will not be asked to alter their diet in any way.

Outcome Measures

Primary Outcome Measures

  1. C-Reactive Protein [Baseline and Week-5 (post measures collected following 1-week group allocation period and 4-week intervention)]

    Change in plasma C-reactive protein from baseline to post intervention.

  2. Prostaglandin E2 [Baseline and Week-5 (post measures collected following 1-week group allocation period and 4-week intervention)]

    Change in plasma Prostaglandin E2 from baseline to post intervention.

  3. Neuropathic Pain Questionnaire (NPQ) [Baseline and Week-5 (post measures collected following 1-week group allocation period and 4-week intervention)]

    Changes in neuropathic pain from baseline to post intervention will be measured using the Neuropathic Pain Questionnaire (NPQ). This questionnaire consists of 32 items which are each ranked on a scale of 0 - 100 whereby 0 indicates the absence of pain and 100 indicates the worst pain imaginable.

  4. Numeric Rating Scale (NRS) [Baseline and Week-5 (post measures collected following 1-week group allocation period and 4-week intervention)]

    Changes in neuropathic pain from baseline to post intervention will also be assessed using the Numeric Rating Scale (NRS). Participants are asked to rate their pain on an 11-point scale ranging from 0-10 whereby 0 indicates no pain and 10 indicates the worst imaginable pain.

  5. International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS). [Baseline and Week-5 (post measures collected following 1-week group allocation period and 4-week intervention)]

    Changes in neuropathic pain from baseline to post intervention

  6. Diet Compliance [Week-5 (post measures collected following 1-week group allocation period and 4-week intervention)]

    Diet compliance will be assessed following the intervention. Compliance to the specific diet will be assessed by a detailed analysis of all diet records. Each food item will be categorized as either a "food to consume," a "food to avoid," or a "neutral food" based on the parameter of the diet participants who were instructed to follow. Food will also be categorized into servings in accordance with Canada's Food Guide. Therefore, compliance score will be based on standard servings of foods subjects were instructed to eat vs. foods they were instructed to avoid. To account for differences in total energy intake, compliance scores will be expressed as a ratio of the servings of foods to consume over the total servings of food (avoid + consume) multiplied by 100. The percent compliance will then be generated.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Signed informed consent obtained prior to any study-related activities

  2. A spinal cord injury at least 6 months duration, nonprogressive for at least 6 months

  3. Dosing of other pain medications (NSAIDs, opioids, non-opioid analgesics, anti-epileptic drugs, antidepressants) should be stable for at least 1 month prior to study entry.

Exclusion Criteria:
  1. Current infection of any kind.

  2. Presence of other neurologic conditions, medical conditions or pain that could confound the assessment of neuropathic pain after SCI

  3. Currently enrolled in another clinical trial

  4. Any other significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, may influence the result of the study, or affect the patient's ability to participate in the study

  5. Following a physical examination, the patient has any abnormalities that, in the opinion of the investigator would prevent the patient from safe participation in the study

Contacts and Locations

Locations

Site City State Country Postal Code
1 Parkwood Institute London Ontario Canada N6C 5J1

Sponsors and Collaborators

  • Lawson Health Research Institute
  • Ontario Neurotrauma Foundation

Investigators

  • Principal Investigator: Eldon Loh, MD, Lawson Health Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT04271904
Other Study ID Numbers:
  • AINP001
First Posted:
Feb 17, 2020
Last Update Posted:
Jul 7, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2022