Clinical and cost effectiveness of a corticosteroid injection versus exercise therapy for shoulder pain in general practice: protocol for a randomised controlled trial (SIX Study)

Introduction Shoulder pain is common and the prognosis often unfavourable. Dutch guidelines on treatment of shoulder in primary care recommend a corticosteroid injection or referral to exercise therapy, if initial management fails persists. However, evidence effectiveness compared with especially long term, limited. This trial will assess clinical cost physiotherapist-led therapy over 12 months follow-up patients care. Methods analysis The SIX Study multicentre, pragmatic randomised A total 213 pain, aged ≥18 years presenting general practice be included. Patients (1:1) into two groups: sessions therapy. effect allocated assessed through questionnaires at 6 weeks after 3, 6, 9 months. outcome patient’s reported pain-intensity function, measured Pain Disability Index, follow-up. Secondary outcomes include effectiveness, pain-intensity, health-related quality life, sleep quality, global perceived effect, work absence, healthcare utilisation adverse events. Between group differences evaluated using repeated measurements linear effects models. cost-utility performed quality-adjusted life from medical societal perspective. Ethics dissemination study was approved by Medical Committee Erasmus MC University Center Rotterdam (MEC 2020-0300). All participants give written informed consent prior data collection. results this disseminated international journals implemented pain. Trial registration number Registry (NL8854).