Can Shoulder Arthroscopy Work?
The CSAW Trial (funded by Arthritis Research UK) is a multi-centre randomised controlled trial (RCT). The primary objective of the study is to determine whether the commonly used arthroscopic sub-acromial decompression surgery is an effective treatment for patients with sub-acromial shoulder pain (impingement). The study comparisons include surgical and non-surgical approaches to treating sub-acromial shoulder pain.
|Arthritis Research UK ref: 19707|
Painful shoulders pose a significant socio-economic burden with sub-acromial shoulder pain being the most frequent cause of shoulder problems in the general population. It is known that a high proportion of patients with sub-acromial shoulder pain will respond well to conservative treatment alone. For patients who have symptoms resistant to conservative measures arthroscopic sub-acromial decompression surgery (ASAD) is the most commonly performed surgical intervention.
ASAD has been used in the treatment of sub-acromial shoulder pain for over 35 years and the number of procedures performed has significantly increased over time. A fact made remarkable by the absence of any compelling or concrete evidence in support of the procedure. Various studies have been performed but there has not been a randomised controlled trial performed on patients with sub-acromial shoulder pain that shows ASAD to be more effective than simply inserting the arthroscope or doing nothing at all. The NHS Database of Uncertainties about the Effects of Treatment (DUETs) confirms this lack of evidence. They highlight the low level of evidence available and the high susceptibility of bias which exists in some publications on the topic. Therefore, we remain ignorant to the mode of action for any potential therapeutic effect. CSAW aims to test all three treatment options satisfactorily.
CSAW is an RCT with a pragmatic design that compares non-operative Active Monitoring with Specialist Reassessment (AMSR) to surgical management (ASAD) a comparison of shoulder arthroscopy only (AO) and ASAD will also be made.
Primary outcome measure: Oxford Shoulder Score (OSS) at 6 months.
Secondary outcome measures: OSS at 12 months, PainDETECT, EQ-5D, Constant Murley Shoulder Score, Quantitative Sensory Testing, Complications, Treatment expectations, Patient Satisfaction, HADS and perceived disability.
Study Participants and Recruitment
Eligible patients will be recruited by their consultant orthopaedic shoulder surgeon in collaboration with the local CSAW research team. CSAW aims to recruit 300 patients in total over a two year period from more than 20 UK centres. There is a follow up period of 12 months.
Patients will be eligible if they are 75 years or under with a diagnosis of sub-acromial pain (tendinopathy and partial tear only). Required criteria are that pain has been present for at least 3 months, the patient has failed a conservative management programme (physiotherapy and at least one cortisone injection) and they are eligible for arthroscopic surgery. The patient must not meet any of the exclusion criteria.
Who is running CSAW?
The Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS) coordinate the study.
Co-Chief Investigators: Professors David Beard and Andrew Carr.
Lead Investigator: Mr Jonathan Rees
Trial Manager: Mrs Cushla Cooper
Trial Coordinator: Miss Naomi Cummings
CSAW Principal Investigators (August 2013)Dan Rossouw, Cheryl Baldwick, Socrates Kalogrianitis, Bambos Charalambous, Tim Matthews, Steven Drew, Sohail Butt, Colin Senior, David Burton, Julie McBirnie, Vipul Patel, Philip Rosell, Rohit Kulkarni, Amitabh Dwyer, Chris Roberts, Lucy Dennell, Jim Gray, Bijayendra Singh, David Gidden, Peter Hallam, Cormac Kelly, Chris Little, Mark Brinsden, Harry Brownlow, Philip Ahrens, David Woods, Veronica Conboy, Matt Stanislas, Soren Sjolin, David Robinson, Geoffrey Taylor, Andrew Chambler.