UK FROST: Multi-centre randomised controlled trial with economic evaluation and nested qualitative study comparing early structure physiotherapy versus manipulation under anaesthesia versus arthroscopic capsular release for patients referred to secondary care with a frozen shoulder (Adhesive Capsulitis).
Frozen shoulder is a painful and debilitating condition causing stiffness and disability in the affected shoulder and arm. The capsule, or the soft tissue envelope around the ball and socket shoulder joint, becomes scarred and contracted, making the shoulder very tight, painful and stiff. It affects around 1 in 12 men and 1 in 10 women of working age, causing interference with their work, domestic and leisure activities. Although this condition tends to improve and settle with time (typically taking 1 to 3 years), for some people it causes severe symptoms and needs more active treatment.
Treatment in hospital may involve:
- Early structured physiotherapy (ESP), steroid injection is also used for pain relief.
- Manipulation under anaesthesia (MUA) is a day case procedure which involves controlled manipulation of the affected shoulder whilst the patient is under general anaesthesia. The manipulation stretches and tears the tight capsule, restoring range of motion to the shoulder.
- Arthroscopic capsular release (ACR), typically as a day case procedure, is where the contracted and tight shoulder capsule is released using arthroscopic (keyhole) techniques, followed by manipulation to confirm restoration of range of motion in the shoulder.
Although all three of these treatments are regularly provided in the NHS, we do not currently know which one works best and at what cost.
As part of the UK Frozen Shoulder Trial we will compare the above three treatments by randomly putting patients into one of three groups. We will measure improvements in participants’ pain, function and general well-being at 3, 6 and 12 months following their entry into the trial.
We will also assess any problems or complications that may arise following these treatments. In addition, we will ask some patients and doctors about their experience of frozen shoulder. We will also review and update the literature at the end of the study about which treatments work for patients with frozen shoulder.