Instant analgesic effect of radial extracorporeal shock wave therapy on primary dysmenorrhoea according to functional magnetic resonance imaging: Study protocol for a randomised placebo-controlled trial
Bibliographic record
Abstract
Abstract Background: Primary dysmenorrhoea (PDM) is defined as a series of pain-dominated symptoms during and after menstruation without organic lesions. Non-steroidal anti-inflammatory drugs and oral contraceptives are usually recommended as first-line drugs for the clinical treatment of PDM, but their widespread long-term application is controversial. Radial extracorporeal shock wave therapy (rESWT) has been widely applied in musculoskeletal rehabilitation because of its secure and non-invasive characteristics and its confirmed effect in improving pain symptoms. This research seeks to explore the efficacy of rESWT for PDM and the changes in brain function of patients with PDM. Methods: This clinical research will be a randomised, evaluated blind and sham-controlled trial. Forty-six patients with PDM will be divided into the rESWT group (n = 23) and the sham rESWT group (n = 23) at random. In the rESWT group, treatment will be applied once within 48 hours of menstruation at six abdominal myofascial trigger points. The sham rESWT group will receive sham shockwave therapy on the same sites but without energy input. Other dysmenorrhoea-related treatments in both groups will be limited. The main indicators include the short-form McGill Pain Questionnaire and the Cox Menstrual Symptom Scale. The secondary indicators include the Zung Self-rating Anxiety Scale and Self-rating Depression Scale and functional magnetic resonance imaging (fMRI) changes in brain regions. Results will be evaluated at the screening, baseline and before and after treatment, and adverse treatments will be examined. Inter- and intra-group analyses will be performed in the statistics section. Discussion: This randomised controlled study is designed to explore the immediate efficacy of rESWT for PDM. After rESWT treatment, PDM symptom tests, pain tests as well as fMRI data will be investigated for the potential connections between immediate neuroanalgesic mechanisms, which are associated with pain and brain networks. The main results will be used to assess the efficacy of rESWT, and secondary results will focus on improving the neurobiological understanding of disease treatment.
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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 | 0.014 | 0.012 |
| Meta-epidemiology (narrow) | 0.006 | 0.002 |
| Meta-epidemiology (broad) | 0.015 | 0.005 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.002 | 0.003 |
| Scholarly communication | 0.003 | 0.003 |
| Open science | 0.003 | 0.002 |
| Research integrity | 0.006 | 0.004 |
| Insufficient payload (model declined to judge) | 0.048 | 0.008 |
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".