Effect of Diet on Neuropathic Pain After Spinal Cord Injury
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Inflammation
- Neuropathic Pain
- Spinal Cord Injury
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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.Masking: Triple (Participant, Care Provider, Investigator)Masking Description: No other parties will be masked for the study.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 sid...
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).
Tracking Information
- NCT #
- NCT04271904
- Collaborators
- Ontario Neurotrauma Foundation
- Investigators
- Principal Investigator: Eldon Loh, MD Lawson Health Research Institute
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