The Anti-Freaze-F Study- "Anti-TNF for Treatment of Frozen Shoulder - a Feasibility Study"
Status:
Not yet recruiting
Trial end date:
2023-05-31
Target enrollment:
Participant gender:
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. The investigators need to conduct this smaller study
first to be sure it's possible to identify and treat people with early stage frozen shoulder,
before they conduct a much larger trial to find out if this treatment works.
In this study the investigators 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. The investigators 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.
Phase:
Phase 3
Details
Lead Sponsor:
University of Oxford
Collaborators:
180 Life Sciences National Institute for Health Research, United Kingdom