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This study evaluates the combination of a CBD or THC/CBD capsule and an anti-inflammatory diet in the treatment of neuropathic pain in spinal cord injuries. In the first part of the study participants will receive either a THC/CBD Capsule with placebo diet, a CBD capsule with placebo diet, a placebo capsule with an anti-inflammatory diet, or a placebo capsule and diet. In the second part participants will either receive a placebo capsule and placebo diet, an anti-inflammatory diet and THC/CBD capsule, or an anti-inflammatory diet and high CBD capsule.
Cannabinoids and an anti-inflammatory diet are two novel treatments that may be beneficial for managing Neuropathic Pain (NP) after Spinal Cord Injury (SCI).
Neuropathic pain 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. Cannabinoids and an anti-inflammatory diet may provide pain relief while being better tolerated.
The Co- Sponsor Investigators will test the potential benefits of these treatments for neuropathic pain after SCI.
Clinically, cannabinoids have been shown to be effective in the management of central NP after multiple sclerosis (MS), and although they have been trialed for a variety of complications after SCI, direct evidence for their ability to manage NP in this population is limited. Accordingly, the CanPainSCI Clinical Practice Guidelines concluded that the evidence is insufficient to develop a specific recommendation regarding cannabinoids in the treatment of NP after SCI. In addition, relevant side effects for those with SCI have not been well documented. Despite this, cannabinoids have been increasingly used as a treatment option for NP after SCI, particularly given increased access to, and greater societal acceptance of, cannabinoids in general. Studies that evaluate the effectiveness and side effects of cannabinoids in the SCI population are therefore urgently needed.
An anti-inflammatory diet has recently shown promise in the management of NP after SCI. An RCT comparing an anti-inflammatory diet to placebo identified a reduction in sensory NP symptoms following SCI. This RCT was done in a general population of SCI patients, and did not necessarily select those who were experiencing significant neuropathic pain. Therefore, additional evidence to demonstrate treatment effect will be important to justify widespread adoption of this diet for NP after SCI.
The study will collect data on a sample of up to 144 patients with SCI and at- and/or below-level neuropathic pain >3/10 in severity on the numeric rating scale.
The Principal Investigators will assess the treatment's effects on quality of life and pain management. If the study is successful, the results (and an evaluation of the process) will be used to inform an affordable and sustainable anti-inflammatory nutrition program to be implemented at Power Cord. This nutrition program will also be widely disseminated and potentially act as a template for similar programs In SCI care centres across Canada.
This study will assess blood samples at three time points for analysis of pro and anti-inflammatory markers. The research coordinator (blinded to the randomization) will assess patients using various quality of life and pain assessment questionnaires during clinic visits, at home or by telephone interview.
The type, level, and completeness of injury will be documented, and, if necessary, updated at each in-person visit. Each participant will be provided with instructions and study schedule. Protocol compliance will be tested through product count and interviews at each follow-up visit. Side effects will be assessed using standardized case report forms at each visit. Study visits may be in person or over the phone. Participants will be encouraged to report any events they may experience directly to the coordinator.
Participants who withdraw consent to continue treatments, will be encouraged to undergo the planned assessments. Withdrawal at the request of investigators or medical personnel may include, but are not limited to:
1. Symptoms are deemed to be potentially related to the study product
2. New diagnosis of exclusion criteria;
3. Unacceptable side effects;
Estimated time to complete recruitment: Averaging 36 months, approximately 3 years.
Spinal Cord Injuries
Placebo diet, Anti-inflammatory diet, TCH/CBD Capsules, High CBD Capsules, Placebo capsules
Not yet recruiting
Lawson Health Research Institute
Published on BioPortfolio: 2019-08-17T19:30:42-0400
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