Anti-TNF (adalimumab) injection for the treatment of adults with frozen shoulder during the pain predominant stage protocol for a multi-centre, randomised, double blind, parallel group, feasibility trial

Objectives: The Anti-Freaze-F trial will assess the feasibility of conducting a large randomised controlled to whether intra-articular injection anti-TNF (adalimumab) can reduce pain and improve function in people with predominant early stage frozen shoulder. Methods analysis: We are multi-centre, study, an embedded qualitative sub-study. recruit adults ≥18 years new episode shoulder attributable shoulder, recruited from at least five UK NHS musculoskeletal related physiotherapy services. Participants (n=84) be (centralised computer generated 1:1 allocation) receive either: 1) (adalimumab 160mg) or 2) placebo (saline [0.9% sodium chloride]), both under ultrasound guidance. A second allocated treatment 80mg) equivalent volume administered 2-3 weeks later. All participants advice leaflet providing education about management. primary objectives are: ability screen identify potential shoulder; willingness eligible consent intervention; 3) practicalities delivering intervention, including time first number receiving injection; 4) standard deviation Shoulder Pain Disability Index (SPADI) score attrition rate 3 months baseline order estimate sample size for definitive trial. also follow up rates viability patient-reported outcome measures range motion Research Ethics Committee approval (REC 21/NE/0214). Trial registration number: ISRCTN 27075727; EudraCT number: 2021-003509-23; ClinicalTrials.gov NCT05299242.