Anti-TNF for Treatment of Frozen Shoulder – a Feasibility Study
Research type
Research Study
Full title
Anti-TNF (adalimumab) injection for the treatment of adults with frozen shoulder during the pain-predominant phase: a multi-centre, randomised, double blind, parallel group, feasibility study
IRAS ID
1004069
Contact name
Jagdeep Nanchahal
Contact email
Sponsor organisation
University of Oxford Research Governance, Ethics and Assurance Team (REGA
Eudract number
2021-003509-23
Research summary
Frozen shoulder is a common condition affecting approximately 9% of people aged 25-64 years. During the early phase the pain is usually unbearable and the later restriction in movement is severely limiting. It occurs when the flexible tissue (capsule) that surrounds the shoulder joint becomes inflamed, thickened and tight. The pain can be very severe and lasts 3-9 months, followed by a 4-12 month period of increasing stiffness, after which the condition usually improves. Frozen shoulder often affects a person’s ability to sleep, carry out everyday activities, and work. Current treatments include rest, painkillers, anti-inflammatories, physiotherapy and steroid injections. If stiffness persists, surgery is sometimes recommended. However, there is no evidence that any of these treatments lead to significant benefit in the long term, with many being ineffective. The aim of this study is to find out if it is possible to run a larger trial to test whether an injection of adalimumab can reduce pain and prevent the disease from getting worse, if given during the early painful phase of frozen shoulder. We need to conduct this smaller study first to be sure it’s possible to identify and treat people with early stage frozen shoulder, before we conduct a much larger trial to find out if this treatment works.
In this study we will include 84 adults from 5 sites with painful early stage frozen shoulder who have not yet received treatment. People will be randomised to receive either an injection of the drug adalimumab or a dummy injection of saline (placebo) directly into the shoulder joint, both guided by ultrasound. All participants will also receive standardized advice on how to manage their shoulder pain. We will assess participants before treatment and three months later. Adalimumab has been used very successfully to treat other inflammatory diseases such as rheumatoid arthritis. This study has been funded by the NIHR RfPB programme and 180 Life Sciences.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
21/NE/0214
Date of REC Opinion
20 Dec 2021
REC opinion
Further Information Favourable Opinion