Cryotherapy following rotator cuff repair version 1
Research type
Research Study
Full title
A Feasibility Study of a Randomised Controlled Trial to Assess the Effect of Cryotherapy vs Standard Treatment Following Arthroscopic Rotator Cuff Repair.
IRAS ID
188490
Contact name
Chris Roberts
Contact email
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
Torn rotator cuff tendons in the shoulder may be treated by rotator cuff repair surgery. This surgery is painful especially in the first two weeks post-operatively.
There is some evidence that using cold/ice therapy following knee surgery may help to lessen the pain. It is not known whether cold/ice therapy helps to reduce pain following shoulder surgery.
The purpose of this study is to evaluate whether ice/cold therapy helps following tendon repair surgery to the shoulder. This means in the future we will know whether this treatment helps and, if it does, we can use it for all patients undergoing this operation.
This study will be conducted at Ipswich Hospital NHS Trust. All patients placed on the waiting list for rotator cuff surgery will be offered to take part as long as they fit the inclusion and exclusion criteria. Participants will be randomised into one of two groups. Both groups will receive standard care and physiotherapy following the surgery. One group will also be given a cold therapy device in addition to standard care.
Both groups will be asked to complete a diary of questions regarding their pain, sleep quality and use of painkillers. The diary will start on the day of surgery and will be completed every day for two weeks. The questions will also be asked at their 4 and 6 week physiotherapy appointments. Data collection continues for 6 weeks.
This study is a feasibility study to assess the method, and provide the information about how many participants would be needed for a significant full size study.
The study is funded by the British Elbow and Shoulder Society. The cold therapy devices are in the form of IceBands™, and are supplied by IBMedical.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
15/EE/0400
Date of REC Opinion
13 Jan 2016
REC opinion
Further Information Favourable Opinion