Abstract
Study design
Multicenter, randomized, double-blind, placebo controlled, clinical trial.
Objective
The objective of this paper is to evaluate the effectiveness of cannabinoids and an anti-inflammatory diet, alone and in combination, for the management of neuropathic pain (NP) after spinal cord injury (SCI).
Setting
Two Canadian SCI rehabilitation centers.
Methods
A sample of 144 individuals with SCI will receive either an anti-inflammatory diet, cannabinoids or a placebo for 6 weeks. Following this, a combined effect of these treatments will be evaluated for a further 6 weeks. The primary outcome measure will be the change in NP as assessed by the numeric rating scale (NRS). Secondary outcomes will include changes in inflammation, mood, sleep, spasticity, cost-effectiveness, and function.
Conclusion
This study will assess the efficacy of an anti-inflammatory diet and cannabinoids (individually and in combination) for the treatment of NP following SCI. Results may reveal a cost-effective, side-effect free intervention strategy which could be utilized for the long-term management of NP following SCI.
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Data availability
The data sets used and/or analyzed during the current study are available from the corresponding author on request.
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Funding
This study is funded by a grant from the Ontario Neurotrauma Foundation.
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DSD and EL were substantially involved in the conception and design of the study. ARA, DJA, DSD, and EL are participating in the coordination of the study and the acquisition of data. DJA drafted the paper with the assistance of DSD, EL, ARA, and BCFC. DSD, EL, BCFC, and AR critically revised the text. The present publication has been approved by all involved.
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The protocol, informed consent form, recruitment materials, and all participant materials will be submitted for ethical approval through the University of Western REB and the Brock University REB prior to participant recruitment. The study will be conducted in full conformity with the ICH E6, Health Canada Food and Drugs Act, and Good Clinical Practice.
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Allison, D.J., Agudelo, A.R., Chan, B.C.F. et al. Cannabinoids and an anti-inflammatory diet for the treatment of neuropathic pain after spinal cord injury (The CATNP Study): study protocol for a randomized controlled trial. Spinal Cord 59, 112–122 (2021). https://doi.org/10.1038/s41393-020-0508-5
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DOI: https://doi.org/10.1038/s41393-020-0508-5
