Spinal Cord Trauma, Pain
Conditions
Keywords
The outcome is to prevent Central Neuropathic Pain, participants will have suffered spinal cord trauma
Brief summary
This research study will test to see if people who receive pregabalin after their spinal cord injury will develop less nerve damage pain than people who do not receive it.
Detailed description
Pregabalin is one of the few agents that have demonstrated effectiveness in the treatment of central NeP in SCI. Research is now proving that it is possible to prevent the development of pain in certain conditions. Pregabalin has been proven effective in this area with post surgical pain. Therefore, after traumatic SCI there may be a small window of time where we could prevent the development of NeP by administering an agent like Pregabalin. Objective: To test the hypothesis that pregabalin is an effective treatment in preventing post-spinal cord injury neuropathic pain. Design: double-blind, placebo controlled, randomized, trial Setting: Spinal cord injury program, neurosurgery and tertiary care rehabilitation center Subjects: 30 patients with acute traumatic spinal cord injury Method: Pregabalin will be offered to patients with acute traumatic spinal cord injury pain in a double blind crossover, placebo control design. Main Outcome Measures: The primary outcome measures will be the development of Neuropathic Pain and intensity of pain Secondary outcome measures will be Ashworth's Scale for spasticity and ASIA motor and Sensory Scores. Results: To be determined. Conclusion: To be determined.
Interventions
DRUGLyrica
study participants will start will be on 150mg of Pregabalin or placebo capsules by mouth , twice a day.They will be on drug approx. 49 weeks and followed for another 49 weeks after stopping the medication.
DRUGmatching placebo
150 mg by mouth ,twice a day for 49 weeks
Sponsors
Nova Scotia Health Authority
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Eligible participants will be 18 years of age or older * Have suffered a traumatic spinal cord injury (complete or incomplete) * Be free of Neuropathic pain * Be in stable medical condition
Exclusion criteria
* Pregnant or lactating women: Because we do not know the risks of pregabalin in pregnancy, females of child bearing years must have a negative pregnancy test (performed on screening and subsequent follow up visits) and be using a reliable method of birth control including oral or injectible birth control hormones, barriers, intrauterine devices or tubal ligation, or abstinence throughout the duration of the study. * Should a female become pregnant while participating in the study she will be un-blinded and, if on pregabalin, she will be weaned from the medication as quickly as is safe and withdrawn from the study. Appropriate follow-up for any pregnancy complications will be conducted. * Persons with known hypersensitivity to pregabalin or its constituents * Persons with Neuropathic pain at the time of enrollment * Persons with a chronic pain diagnoses that may interfere with the evaluation of the presence of Neuropathic pain
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measures will be the development of Neuropathic Pain and intensity of pain . | the trial is 74 weeks in length |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures will be Ashworth's Scale for spasticity and ASIA motor and Sensory Scores. | trail is 74 weeks in length |
Countries
Canada
Outcome results
None listed