Tibetan medicine pain relieving plaster for treatment of knee osteoarthritis: protocol for a multi-center, randomized, and positive drug controlled trial
Bibliographic record
Abstract
Objective: This trial aims to evaluate the effectiveness and safety of a Tibetan medicine pain relieving plaster (PRP) in knee osteoarthritis (KOA) management, generating evidence-based support for clinical application. Method: This multi-center, randomized, positive drug-controlled, non-inferiority trial will evaluate the effectiveness and safety of the PRP in symptomatic participants with KOA. The trial will enroll 440 participants, allocated in a 1:1 ratio to the PRP group and flurbiprofen cataplasms group. All participants will undergo a 7-day treatment period followed by 14-day post-treatment monitoring. We will assess pain severity by the pain dimension score of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale, and evaluate knee joint function using the stiffness and joint function dimension scores of the WOMAC scale and knee joint range of motion. We will assess joint swelling by measuring knee circumference. The quality of life will be evaluated using EQ-5D-5L scale, with utility scores calculated based on utility values and changes in the frequency of each level across dimensions. For safety assessment, we will perform blood laboratory tests, detailed recording of adverse events, and assessment of the severity of local skin reactions to the plaster based on a four-point Likert scale. In addition, we will record information related to plaster use, compliance, and the use of rescue therapy. Discussion: This methodologically robust randomized controlled trial will comprehensively characterize PRP's therapeutic potential in KOA management, specifically examining its impacts on core clinical manifestations (pain, mobility restriction, joint swelling) and patient-reported outcomes. The findings will inform evidence-based utilization of this approved Tibetan medicinal formulation in real-world clinical practice.
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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 | 0.028 | 0.024 |
| Meta-epidemiology (narrow) | 0.006 | 0.002 |
| Meta-epidemiology (broad) | 0.009 | 0.005 |
| Bibliometrics | 0.002 | 0.003 |
| Science and technology studies | 0.003 | 0.003 |
| Scholarly communication | 0.004 | 0.004 |
| Open science | 0.004 | 0.002 |
| Research integrity | 0.007 | 0.008 |
| Insufficient payload (model declined to judge) | 0.063 | 0.012 |
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".