AntiFreazeF (AFF)

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

Background

Frozen shoulder is a common, painful shoulder condition affecting approximately 9% of people aged 25 to 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.

It is not fully understood why this happens but it is more common in people with diabetes. It can also occur following shoulder injury or surgery.

The pain can be very severe and lasts 3 to 9 months, followed by a 4 to 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.

What we did

The aim of the study was to assess the feasibility of conducting a large randomised controlled trial to test whether an injection of a drug called adalimumab can reduce pain and prevent frozen shoulder from getting worse if given during the early painful phase.

We recruited up to 70 adults with pain predominant early stage frozen shoulder who have not yet received treatment.

Patients were randomised to receive either an injection of adalimumab (80mg) or a dummy injection (saline) directly into the shoulder joint capsule guided by ultrasound. All patients also received advice from a physiotherapist on managing their shoulder problem.

We assessed patients before injection and at three months after injection.

The main objective of this feasibility study was to find out if it is possible to identify and treat people with early stage frozen shoulder within the current United Kingdom (UK) NHS, so we know whether it is possible to run a much larger study to find out if this treatment works.