Anti Freaze-F is funded by the National Institute of Health Research - Research for Patient Benefit
Project reference: 201031
The ANTI Freaze-F Study will assess the feasibility of conducting a large randomised controlled trial to assess whether an injection of adalimumab can reduce pain and improve function in people with pain predominant early stage frozen shoulder.
People will be randomised to receive either an injection of the drug adalimumab or a dummy injection of saline directly into the shoulder joint guided by ultrasound. All participants will also receive advice on how to manage their shoulder pain. Participants will be assessed before treatment and then again three months later.
We need to conduct this smaller study first to be sure it's possible to identify and treat people with early stage frozen shoulder within the current NHS system, before we conduct a much larger study to find out if this treatment works.
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. It's not fully understood why this happens but it is more common in people with diabetes or Dupuytren's disease, which causes the fingers to curl into the palm. It can also occur following shoulder injury or surgery. 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. Steroid injections only help in the short term.
Aims and objectives
The aim of this study is to find out if it is possible to run a larger study 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 study will also look at the follow up rates and viability of patient reported outcome measures and range of shoulder motion at 3 months follow up for a definitive trial.
ANTI FREAZE-F is a Randomised, Parallel, double blinded study.
Sample size: 84 participants will be recruited from five sites in the UK.
Population: Men and women ≥18 years with a new episode of shoulder pain attributable to early stage frozen shoulder who have not received injection or physiotherapy for shoulder pain in the last 3 months, nor being considered for surgery.