Viscoseal Post-Arthroscopic Release of Adhesive Capsulitis Shoulder v1
Research type
Research Study
Full title
Viscoseal Post-Arthroscopic Release of Adhesive Capsulitis of the Shoulder: a randomised, controlled proof-of-principle study in adults (version 1).
IRAS ID
82185
Contact name
Muthu Jeyam
Contact email
Sponsor organisation
Research and Development Department, Salford Royal NHS Foundation Trust.
Research summary
Might a single infusion of Viscoseal® (an artificial joint oil, or hyaluronan) be beneficial to adults after key-hole surgery for frozen shoulder?
Frozen shoulder is a painful, debilitating stiffening-up of the shoulder, caused by adhesion-formation in the capsule surrounding the joint. It affects large numbers of people every year, causing them to be off work for long periods. It causes considerable burden on health services.
Generally it gets better by itself over 6-18 months. However, sometimes it can last as long as three years, leaving a permanently stiff shoulder. In such cases, key-hole capsular release surgery may be required to restore movement.
Replacement of the natural joint oil, which gets washed away during surgery, with hyaluronans, has resulted in improvements in pain and function in other joints and conditions. Hyaluronans can also help prevent adhesion formation in those prone to it, such as people with frozen shoulder.
This hospital-funded pilot randomised controlled study will investigate whether Viscoseal® can help people recover from key-hole release surgery. (Viscoseal®) has a proven safety-record and is licensed in the UK.
We will recruit about 30 people waiting for this surgery at Salford Royal NHS Foundation Trust and randomly assign them to either a group that gets Viscoseal® at the end of the surgery, or another group that doesn’t. Participants won’t be told which group they are in, but both groups will receive the best clinical care, with physiotherapy after the surgery. They will be expected to attend the hospital to fill in questionnaires and have a brief examination of their shoulder before their operation, and then again, after their operation, in weeks 1 and 2 and in months 1, 3 and 6.
The results of this study will be used to plan a larger trial of Viscoseal® after key-hole release surgery for frozen shoulder.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
14/NW/0012
Date of REC Opinion
23 Jan 2014
REC opinion
Favourable Opinion