Table 1 Eligibility criteria for including trials in the IPD meta-analysis
| Â | Include | Exclude |
|---|---|---|
Design | Randomised clinical trials, including individual and cluster-randomised trials, no language restrictions | Any other non-randomised design |
Setting | Any healthcare setting | Preventative intervention studies (e.g. in workplace settings) |
Population | ▪ Adults (18 years and older) ▪ General or non-specified shoulder pain or diagnosed with (i) subacromial condition (rotator cuff tendinopathy, rotator cuff tear, subacromial bursitis), (ii) frozen shoulder/adhesive capsulitis, (iii) glenohumeral osteoarthritis, (iv) shoulder instability. | ▪ Acute trauma (fractures, traumatic dislocations) ▪ Inflammatory arthritis (rheumatoid arthritis, polymyalgia rheumatica) ▪ Shoulder pain resulting from cervical radiculopathy ▪ Stroke-related shoulder pain |
Interventions | â–ª Corticosteroid injection â–ª Physiotherapy-led exercise (with or without manual therapy) â–ª Interventions addressing psychological factors (e.g. cognitive behavioural approaches, multimodal interventions) â–ª Surgical interventions | Other, less common treatment options, or treatments with very limited evidence of effectiveness |
Control | â–ª Advice and pain relief only â–ª Sham/placebo intervention â–ª Direct comparisons between the interventions listed above | â–ª Comparisons with other interventions â–ª Comparisons of different dosages, types, or modes of delivery of the same intervention |
Outcome measure | ▪ Shoulder pain intensity (VAS, 0–10 NRS, validated shoulder-pain specific questionnaire) ▪ Shoulder function (NRS, VAS, validated shoulder disability questionnaire). | No baseline and follow-up data for either one of these outcomes |
Candidate predictors | At least one of the following potential predictors in addition to baseline levels of the outcome measure (pain or disability): shoulder pain duration, sleep disturbance due to shoulder pain, presence of weakness, cause of shoulder pain (injury, or overuse due to work/hobbies), co-existing neck pain, psychosocial complexity (fear-avoidance, catastrophizing, anxiety, depression, other), positive expectations or preferences regarding treatment, presence of comorbidities. | Â |
Length of follow-up | Follow-up assessment at least 4 weeks after randomisation | Trials including only very short-term follow-up (e.g. after a single intervention session) |
Sample size | Minimum sample size at randomisation, 30 per intervention arm | Â |