CSAW (Can Shoulder Arthroscopy Work)
Is Arthroscopic Sub-Acromial Decompression (ASAD) More Effective Than Arthroscopy Only (AO) for Shoulder Pain
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. The Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS) coordinates the study via the Surgical Intervention Trials Unit (SITU) in collaboration with the co-chief investigators Professors David Beard and Andrew Carr.
This study aims to compare surgical treatment for sub-acromial shoulder pain (ASAD) against a non-operative arm, Active Monitoring with Specialist Reassessment (AMSR). In addition, both ASAD surgery and AMSR will be separately compared to investigational shoulder arthroscopy (AO) to delineate the mechanism for any benefit.
The Primary Outcome Measure is the Oxford Shoulder Score (OSS) at 6 months.
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 used 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 carried out but there has not been a randomised controlled trial (RCT) 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 management options satisfactorily.
Study Participants and Recruitment
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 three year period from 32 centres across the UK. Patients will be followed up for 12 months. Information to be collected and analysed includes: • Patient focused questionnaires relating to shoulder pain and function. • Patient focused questionnaires relating to economic costs of the treatments and health care resources utilised. • Practical assessments of range of movement, function and strength
- Sub-acromial pain of at least 3 month duration (tendinopathy and partial tear only).
- Consultant diagnosis of tendinopathic pain or partial thickness rotator cuff tear.
- Eligible for arthroscopic surgery.
- Completed a conservative management programme previously including both:
- Physiotherapy that includes a remedial exercise regimen.
- At least one cortisone injection.
- Full thickness tear of the rotator cuff tendon or calcific tendonitis evident on routine imaging.
- Other pathology (non-impingement related) identified on MRI or Ultrasound Scan.
- Undergone any of the following surgeries on the affected shoulder:
- Cuff Repair
- Joint Replacement
- Surgery involving the GHJ in the past 3 years
- Rheumatoid Arthritis or any other inflammatory disorder of the joints.
- Symptomatic cervical spine pathology.
- Previous septic arthritis in the shoulder only.
- History of radiotherapy on the same side as the affected shoulder.
- Patients who:
- Are unlikely to be able to perform the required clinical assessment tasks
- Have significant cognitive impairment or language issues
- Are unable to consent for themselves
- Older than 75 years
The CSAW Team
The investigating research team at the University of Oxford is led by Professors David Beard and Andrew Carr and is supported by a team of collaborators consisting of academic and clinical staff, surgeons, physiotherapists and nurses with research experience and expertise in orthopaedics.
Professor David Beard
Professor of Musculoskeletal Sciences
Professor Andrew Carr
Nuffield Professor of Orthopaedic Surgery
Professor Jonathan Rees
Associate Professor of Orthopaedic Surgery and Consultant Orthopaedic Surgeon
Ms Ines Rombach
Mrs Cushla Cooper
SITU/OSIRIS Trials Manager
Professor Irene Tracey
Nuffield Professor of Anaesthetic Science
Professor Alastair Gray
Professor of Health Economics
Associate Professor Jonathan Cook
SITU/CSM Surgical Trials Methodologist
Mr Stephen Gwilym
Honorary Senior Lecturer and Consultant Orthopaedic Surgeon
Associate Professor Andrew Judge
CSAW Satellite Studies
- The CSAW Patient Preference Study
Patients who are eligible for the main CSAW study but decline due to a strong preference for one type of treatment will be invited to take part in this study. Participants will complete questionnaires relating to their treatment preference, reasons for not wanting to be randomised and their satisfaction with their chosen treatment. Follow-up is at 12 months (postal questionnaire).
- The CSAW Qualitative Recruitment Investigation (QRI)
This study is run in collaboration with the University of Bristol (Professor Jenny Donovan, Dr Caroline Wilson and Dr Marcus Jepson). The aim of the investigation is to characterise and understand the success/failure of the CSAW recruitment process. This investigation will specifically identify sources of recruitment difficulties. The Bristol team will review findings and suggest changes that could lead to improvements in recruitment.
- The CSAW Tissue Sample Study (this study is being run at the Oxford site only).
Main study patients from Oxford who are randomised to have a surgical procedure will be invited to participate in this study, although, tissue will only be taken from those having ASAD. Tissue that is routinely removed and discarded will be analysed to help provide a better understanding of the molecular processes involved in tendon degeneration and shoulder pain.
- The CSAW Neuroimaging Study (this study is being run at the Oxford site only).
Main study and Patient Preference Study patients from the Oxford site will be invited to undergo Functional Magnetic Resonance Imaging of the Brain (FMRIB). This study will investigate the neural correlates of the ASAD and compare them with the non-therapeutic diagnostic arthroscopy (AO).