David J Allison1,2,3,4, Alexandria Roa Agudelo5,6,7, Brian C F Chan8,9, David S Ditor10, Eldon Loh5,6,7. 1. Lawson Health Research Institute, London, ON, Canada. allisodj@mcmaster.ca. 2. Department of Kinesiology, McMaster University, Hamilton, ON, Canada. allisodj@mcmaster.ca. 3. Parkwood Institute, London, ON, Canada. allisodj@mcmaster.ca. 4. Western University, London, ON, Canada. allisodj@mcmaster.ca. 5. Lawson Health Research Institute, London, ON, Canada. 6. Parkwood Institute, London, ON, Canada. 7. Western University, London, ON, Canada. 8. KITE-Toronto Rehabilitation Institute, University Health Network, Toronto, ON, Canada. 9. Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada. 10. Department of Kinesiology, Brock University, St. Catharines, ON, Canada.
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.
RCT Entities:
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.
Authors: S D Guy; S Mehta; A Casalino; I Côté; A Kras-Dupuis; D E Moulin; A G Parrent; P Potter; C Short; R Teasell; C L Bradbury; T N Bryce; B C Craven; N B Finnerup; D Harvey; S L Hitzig; B Lau; J W Middleton; C O'Connell; S Orenczuk; P J Siddall; A Townson; C Truchon; E Widerström-Noga; D Wolfe; E Loh Journal: Spinal Cord Date: 2016-08 Impact factor: 2.772