Spinal Cord Injury
Conditions
Keywords
Cannabis, Marijuana, Spinal cord injury, Pain, Spasticity
Brief summary
The goal of this clinical trial is to compare effects of marijuana or cannabis on neuropathic pain and spasticity in spinal cord injury patients. The main question is: Does the cannabis product from KhonKaen University reduce neuropathic pain and spasticity in spinal cord injury patients? The research design is a crossover study. The participants will be randomly into 2 groups: group 1 and group 2. The participants received either cannabis or placebo for 2 weeks. After completing treatment, participants were swapped to the other group for 2 weeks, a wash-out period is 2 weeks. The outcome measurements are pain and spasticity.
Interventions
Placebo is similar to Cannabis product but do not contain THC.
Cannabis product is from the extraction of the powdered, dried and mature pistillate inflorescences of Cannabis sativa L. containing THC 30mg/ml.
Sponsors
Study design
Eligibility
Inclusion criteria
* Spinal cord injury more than 6 months * Neuropathic pain * Pain score \> 3 * Do not response to standard medical treatment * Given inform consent
Exclusion criteria
* Allergy to cannabis * Unstable cardiovascular and pulmonary diseases * Chronic kidney and liver diseases * Psychological disease * Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score | 2 weeks | Visual analog scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spasticity | 2 weeks | Modified Asworth Score |
| Activities of daily living | 2 weeks | to assess functional outcome |
| Quality of life score | 2 weeks | WHO Bref Quality of life questionnaire |
| H-reflex | 2 weeks | Electrodiagnosis |
Countries
Thailand