Moxibustion using different habitat moxa floss for moderate to severe primary knee osteoarthritis: study protocol for a three-armed randomized, double-blinded, sham-controlled trial
Bibliographic record
Abstract
BACKGROUND: According to the traditional Chinese medicine theory, moxa floss is the best material for moxibustion; the effect of moxibustion is closely related to the habitats of moxa floss, among which Qichun County, Hubei Province, China, is considered as the genuine origin. However, this view has not been validated by clinical studies. Moxibustion has been proven effective in alleviating pain and improving physical function and quality of life for patients with knee osteoarthritis (KOA). This trial aims to determine whether the habitat of moxa floss contributes to the effect of moxibustion and to validate the effectiveness of moxibustion for KOA. METHODS: This is a three-armed, randomized, double-blinded, sham-controlled trial. A total of 350 patients with moderate to severe primary KOA will be randomly allocated to groups A, B, or C with a 2:2:1 ratio. Moxa stick moxibustion using moxa floss from different habitats will be applied in two experimental groups: group A, moxa floss from the habitat of Qichun County, Hubei Province, China; and group B, moxa floss from the habitat of Nanyang County, Henan Province. Group C will use non-moxa floss for sham moxibustion as control. Patients will be treated for 20 min per session, for three sessions per week for 2 weeks, and followed up for 4 weeks. The primary outcome will be the change from baseline in the pain score of the Western Ontario and McMaster Osteoarthritis Index (WOMAC) at week 2. Secondary outcomes will include a change in the WOMAC pain score at week 6; the visual analogue scale for knee pain, the total WOMAC score, the WOMAC stiffness score, the WOMAC function score, the patient global assessment, and the responder criteria at weeks 2 and 6. Adverse events will be assessed throughout the study. DISCUSSION: This trial will help to identify the effectiveness of moxibustion for KOA and whether the habitat of moxa floss contributes to the effect of moxibustion. TRIAL REGISTRATION: Acupuncture-Moxibustion Clinical Trial Registry: AMCTR-IOR-16000007 . Registered on 29 February 2016.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.005 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.005 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
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 teacher head, 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".