Stepped rehabilitation of people with persistent shoulder pain in New Zealand (StePS-NZ): a randomised clinical trial protocol
Bibliographic record
Abstract
BACKGROUND: Rotator cuff-related shoulder pain (RCRSP) is a common musculoskeletal disorder, with prevalence increasing with age. In Aotearoa New Zealand, many people with RCRSP are compelled to seek physiotherapy privately as hospital outpatient clinics have long waiting lists, or go without care. We test the efficacy of Stepped Care, a new approach to RCRSP primary care, to use resources as efficiently as possible. This study aims to (i) define the effectiveness of a Stepped Care Model for persistent RCRSP compared to usual, pragmatic physiotherapy; (ii) explore patients' and the physiotherapists' perspectives and experiences of the interventions and research processes; and (iii) compare the cost-effectiveness of the Stepped Care Model with pragmatic physiotherapy. METHODS: This pragmatic, two-armed parallel-group randomised clinical trial will enrol 200 adults with RCRSP, who are randomised to receive either Usual Physiotherapy or Stepped Care. In the Stepped Care group, all patients receive two 1-h sessions focussing on patient education. After 6 weeks, those with persistent symptoms receive pragmatic physiotherapy, while those whose symptoms have resolved will receive no further intervention. The Usual Physiotherapy group receives up to 10 sessions of pragmatic care over a 3-month period. The primary outcome is upper limb function and severity of symptoms using the QuickDASH at 3 months. Secondary outcomes includes pain severity, pain-related fear, pain self-efficacy and health-related quality of life, assessed at baseline, 6 weeks, 3, 6, and 12 months. Outcome measures in continuous scale, including QuickDASH, will be analysed to estimate the difference in the measure between two physiotherapy treatments, while the measures in categorical/binary scales will be analysed to estimate the differences of proportions with favourable outcomes. Confidence intervals will be used to make noninferiority interpretations. A cost-effectiveness analysis will be conducted at the individual level and reported from a societal perspective. DISCUSSION: If the findings from this study support a stepped care approach to treatment for RCRSP, it could lead to more treatment being available at lower cost to both individuals and the health system. TRIAL REGISTRATION: Universal Trial Number: U1111-1298-4087. Australian New Zealand Clinical Trial registration: ACTRN12624000163505, 21st February 2024.
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How this classification was reachedexpand
Direct model labels (unvalidated)
Per-model category and study-design labels from the labeling rounds. They are machine output, unvalidated, and the disagreement between models ships as data. No study design here is MEDLINE-validated yet.
| Model arm | Categories | Study design | Confidence |
|---|---|---|---|
| gemma | no category Domain: not available · Genre: Protocol About the Canadian research system: no · About a Canadian topic: no | Randomized trial | low |
| gpt | no category Domain: not available · Genre: Protocol About the Canadian research system: no · About a Canadian topic: no | Randomized trial | high |
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 | 0.025 | 0.024 |
| Meta-epidemiology (narrow) | 0.005 | 0.002 |
| Meta-epidemiology (broad) | 0.009 | 0.005 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.002 | 0.003 |
| Scholarly communication | 0.003 | 0.003 |
| Open science | 0.004 | 0.002 |
| Research integrity | 0.007 | 0.005 |
| Insufficient payload (model declined to judge) | 0.061 | 0.007 |
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, unvalidatedLabeled directly by 2 models reading the full record.
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".