Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | The participants will receive cannabis product for 2 weeks. The participants will receive the cannabis product (THC 30mg / 1 ml) manufactured by Faculty of pharmaceutical science KhonKaen University. The participants will gradually increase using the product starting from 1 drop (1.5 mg THC) per day sublingually and can increase using not more than 1 drop per day, until pain or spasticity can be controlled. |
|
| Placebo group | Placebo Comparator | The participants will receive placebo product manufactured by Faculty of Pharmaceutical Science KhonKaen University for 2 weeks. The participants will gradually increase using the product starting from 1 drop per day sublingually and can increase using not more than 1 drop per day, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabis | Drug | Cannabis product is from the extraction of the powdered, dried and mature pistillate inflorescences of Cannabis sativa L. containing THC 30mg/ml. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain score | Visual analog scale | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Spasticity | Modified Asworth Score | 2 weeks |
| Activities of daily living | to assess functional outcome | 2 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nuttaset Manimmanakorn, MD, PhD | Rehabilitation Medicine Department, Faculty of Medicine, KhonKaen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Khon Kaen University | Khon Kaen | 40002 | Thailand |
Individual participant data that underlie the results reported in this article after deidentification.
beginning 3 months and ending 5 years following article published
Researchers who provide a methodologically sound proposal.
Not provided
Not provided
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D002189 | Marijuana Abuse |
| D010146 | Pain |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
Not provided
Not provided
| ID | Term |
|---|---|
| C587251 | nabiximols |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | Placebo is similar to Cannabis product but do not contain THC. |
|
|
| Quality of life score | WHO Bref Quality of life questionnaire | 2 weeks |
| H-reflex | Electrodiagnosis | 2 weeks |
| D014947 | Wounds and Injuries |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |