Ultramicronized Palmitoylethanolamide (PEA) in spinal cord injury neuropathic pain: a randomized controlled trial
Bibliographic record
Abstract
Introduction Neuropathic pain and spasticity after spinal cord injury (SCI) represent significant problems. Palmitoylethanolamide (PEA) is a fatty acid that isproduced in many cells in the body, and it is thought to potentiate endocannabinoids. PEA is suggested to reduce pain and inflammation but RCT arelacking. Normast is a medical supplement which contains PEA approved for use in Denmark. The primary aim was to investigate the effect of Normaston 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. Study population of at least 66 patients must complete the 12 week trial.Questionnaires regarding neuropathic pain, spasticity, insomnia, anxiety and depression are completed before and after treatment. A numeric ratingscale for pain intensity (0-10 point) is used to measure primary outcome.Results Presently, 66 of 68 patients (74% male) 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 31% transport, 27% fall, 21% non-traumatic SCI, 14% other traumatic cause and 7% sports injuries. No major side effectshave been reported. Further results will be presented at the meeting
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.003 | 0.002 |
| Insufficient payload (model declined to judge) | 0.010 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".