Abstract
Introduction:
Neuropathic pain and spasticity after spinal cord injury represent significant problems. Palmitoylethanolamide (PEA) is a fatty acid that is produced in many cells in the body, and it is thought to potentiate the body's own cannabis-like substances (endocannabinoids). PEA is suggested to reduce pain and inflammation but randomized controlled trials are lacking. Normast is a medical supplement which contains (PEA) approved for use in Denmark.
The primary aim is to investigate the effect of Normast (PEA) on neuropathic pain, and secondary to study the effect of Normast on spasticity and psychological functioning in patients with spinal cord injury.
Methods:
A randomized, double-blind, placebo-controlled parallel multicenter study. We have included 66 patients with neuropathic pain due to spinal cord injury. Questionnaires regarding neuropathic pain, spasticity, insomnia, anxiety and depression are completed before and after treatment with either placebo or Normast. A numeric rating scale for pain intensity (0-10 point) is used to measure primary outcome.
Results:
Presently, 66 patients (74% male) are included of which 55 have completed the trial. Of those included, 5% have complete tetraplegia, 39% incomplete tetraplegia, 29% complete paraplegia and 27% incomplete paraplegia.
Average age at inclusion is 55.3 (±9.5) years and average time since injury is 8.8 (±8.9) years.
Causes of injury are 29% transport, 26% fall, 25% unspecified or unknown, 16% other traumatic causes and 4% sports injuries.
No major side effects have been reported. Further results will be presented at the meeting.
Neuropathic pain and spasticity after spinal cord injury represent significant problems. Palmitoylethanolamide (PEA) is a fatty acid that is produced in many cells in the body, and it is thought to potentiate the body's own cannabis-like substances (endocannabinoids). PEA is suggested to reduce pain and inflammation but randomized controlled trials are lacking. Normast is a medical supplement which contains (PEA) approved for use in Denmark.
The primary aim is to investigate the effect of Normast (PEA) on neuropathic pain, and secondary to study the effect of Normast on spasticity and psychological functioning in patients with spinal cord injury.
Methods:
A randomized, double-blind, placebo-controlled parallel multicenter study. We have included 66 patients with neuropathic pain due to spinal cord injury. Questionnaires regarding neuropathic pain, spasticity, insomnia, anxiety and depression are completed before and after treatment with either placebo or Normast. A numeric rating scale for pain intensity (0-10 point) is used to measure primary outcome.
Results:
Presently, 66 patients (74% male) are included of which 55 have completed the trial. Of those included, 5% have complete tetraplegia, 39% incomplete tetraplegia, 29% complete paraplegia and 27% incomplete paraplegia.
Average age at inclusion is 55.3 (±9.5) years and average time since injury is 8.8 (±8.9) years.
Causes of injury are 29% transport, 26% fall, 25% unspecified or unknown, 16% other traumatic causes and 4% sports injuries.
No major side effects have been reported. Further results will be presented at the meeting.
| Originalsprog | Engelsk |
|---|---|
| Publikationsdato | 2015 |
| Status | Udgivet - 2015 |