Condition category
Musculoskeletal Diseases
Date applied
22/06/2012
Date assigned
22/06/2012
Last edited
19/08/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Shoulder problems causing pain and decreased function are very common. Many of these problems are related to the rotator cuff tendons (tissue that attaches muscle to bone). Shoulder arthroscopy (key-hole surgery) is a common treatment for this pain. Treatment can involve an arthroscopic sub-acromial decompression (ASAD) - an operation similar to arthroscopy that also involves shaving off a small part of the bone above the tendons. The procedure is widely used despite limited evidence of any effectiveness. This study will compare ASAD against investigation shoulder arthroscopy (without bone spur removal/decompression) to indicate whether spur removal is really necessary and in turn, assess the effectiveness of the ASAD procedure. Both surgical treatments will be compared to a control (active monitoring with specialist reassessment [AMSR]) group to indicate whether surgery in general is effective for patients with sub-acromial pain.

Who can participate?
300 men and women with sub-acromial shoulder pain.

What does the study involve?
Patients will be randomly allocated into one of three treatment groups: AMSR, arthroscopy and ASAD. All patients will be assessed at three appointments over 12 months. The baseline assessment will occur when they first enter the study; they will then have follow-up assessments at 6 and 12 months. Patients allocated to the AMSR will be reassessed at 3, 6 and 12 months.

What are the possible benefits and risks of participating?
We cannot guarantee any benefit to participants, any of the three treatments being compared would be a good option until the study results are known. The main benefit of taking part is the information gained may help to improve future patient care. There are no anticipated risks to participating in this study, although there will be the usual risks associated with surgery and anaesthesia for participants allocated to the surgical options.

Where is the study run from?
This study is organised by a team based at the Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Sciences (NDORMS) at the University of Oxford.

When is the study starting and how long is it expected to run for?
We aim to start recruiting patients in July 2012 and follow-up will be completed by the end of March 2017.

Who is funding the study?
Arthritis Research UK.

Who is the main contact?
Ms Naomi Cummings, CSAW Trial Co-ordinator
csaw@ndorms.ox.ac.uk

Trial website

http://www.situ.ox.ac.uk/surgical-trials/csaw

Contact information

Type

Scientific

Primary contact

Mrs Cushla Cooper

ORCID ID

Contact details

Nuffield Orthopaedic Centre
Windmill Road
Oxford
OX3 7LD
United Kingdom
-
cushla.cooper@ndorms.ox.ac.uk

Type

Scientific

Additional contact

Ms Naomi Merritt

ORCID ID

Contact details

CSAW Study Trial Co-ordinator
RCS Surgical Intervention Trials Unit (Orthopaedics and Plastics)
NDORMS
University of Oxford
Oxford
OX3 7LD
United Kingdom
+44 (0) 1865 223404
naomi.merritt@ndorms.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT01623011

Protocol/serial number

12104

Study information

Scientific title

What is the clinical and cost effectiveness of arthroscopic sub-acromial decompression surgery for patients with sub-acromial Pain? A randomised trial

Acronym

CSAW

Study hypothesis

Shoulder problems causing pain and decreased function are very common. Many of these problems are related to the rotator cuff tendons. Shoulder arthroscopy surgery (keyhole surgery) is a common treatment for this pain. This can involve an Arthroscopic Subacromial Decompression (ASAD) an operation used to remove bony spurs which may be the cause of the pain. This procedure is widely used despite limited evidence of any effectiveness. This is a randomised controlled trial that will compare ASAD against an investigational shoulder arthroscopy (without spur removal/decompression) to indicate whether spur removal is really necessary and in turn, assessing the effectiveness of the ASAD procedure. Both surgical interventions are routine and will mirror each other except for the spur removal element.

Both treatments will be compared against a control (non operative management with specialist reassessment) group to indicate whether surgery in general is effective for patients with subacromial pain. Patients randomised to either of the surgical options will be blinded to the type of surgery they have.

This is a multicentre trial taking place in 10 centres in England and Wales. Two satellite studies will also take place. One will involve a subset of patients undergoing MRI scans to examine the effects of their shoulder pain on their brain transmissions. The other will involve collecting tissue samples from patients undergoing surgery.

More details can be found at http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=12104

On 23/07/2015 the overall trial end date was changed from 31/03/2016 to 31/03/2017.

Ethics approval

Oxfordshire Research Ethics Committee B, 12/SC/0028; First MREC approval date 16/03/2012

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

http://www.situ.ox.ac.uk/develop/health-economics/csaw-pis-v5.pdf

Condition

Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal

Intervention

Active Monitoring: Patients will be advised that they will undergo active monitoring in the short term. They will attend a reassessment appointment 3 months after entering the study. Here, they will be asked to complete questionnaires related to their shoulder pain and undergo a clinical assessment for their shoulder.

ASAD Surgery, Arthroscopic Sub-acromial Decompression: The procedure is performed under general anaesthetic. Skins incisions are made for the introduction of the arthroscope and required instruments. The procedure involves insertion of the arthroscope into the glenohumeral joint where the joint surface is inspected along with the intra-articular portion of the long head of biceps and the joint surface of the rotator cuff tendons. Once this has been performed the arthroscope is removed and inserted into the sub-acromial joint.

Shoulder Arthroscopy, Arthroscopy Only: This is the surgical comparison group. The procedure is performed under general anaesthetic. Patients will undergo a routine investigational arthroscopy. The operation will be performed in exactly the same manner as Group ASAD. The exception is they will not undergo the decompression (bone spur removal) and the arthroscope is not introduced into the sub-acromial bursa. Tissues will be visualised and the joint will be washed out. The time spent in theatre will be similar to th; Follow Up Length: 12 month(s)

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Oxford Shoulder Score; Timepoint(s): 6 months post randomisation

Secondary outcome measures

1. Constant Murley Score; Timepoint(s): 6 and 12 months post randomisation
2. EQ5D; Timepoint(s): 6 and 12 months post randomisation
3. Hospital Anxiety and Depression Scale (HADS) Questionnaire; Timepoint(s): 6 and 12 months post randomisation
4. Pain DeTECT Questionnaire; Timepoint(s): 6 and 12 months post randomisation
5. Quantitative Sensory Testing; Timepoint(s): 6 and 12 months post randomisation

Overall trial start date

01/07/2012

Overall trial end date

31/03/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Sub-acromial pain of at least 3 month duration
2. Diagnosis by Consultant of sub-acromial pain or partial thickness rotator cuff tear
3. Has had an Magnetic Resonance Imaging (MRI) or Ultrasound scan to rule out alternative pathology
4. Able to undergo arthroscopic surgery
5. Physiotherapy that includes a remedial exercise regime
6. at least 1 previous cortisone injection but not more than 3
7. Inclusion criteria for the FMRI Sub Study is that they must be able to undergo an MRI scan according to safety regulations outlined in the MRI Safety Questionnaire.; 8. Target Gender: Male & Female; Upper Age Limit 75 years ; Lower Age Limit 35 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 300; UK Sample Size: 300

Participant exclusion criteria

1. Full thickness rotator cuff tear (diagnosed/eliminated using Ultrasound or MRI)
2. Undergone previous surgery on affected shoulder
3. Diagnosed rheumatoid arthritis or other inflammatory disorder
4. Symptomatic,cervical spine pathology
5. Previous septic arthritis
6. History of radiotherapy on affected shoulder side
7. Patients who have a strong preference for one treatment over another
8. Patients from the Nuffield Orthopaedic Centre, Oxford who are recruited to the main study will be excluded from the Neuroimaging MRI Scans if any of the following MRI contraindications are present:
8.1. Metal in their body, implants (may cause injury to the participant and produce artefacts on MR scans)
8.2. History of severe claustrophobia (may cause discomfort inside the MRI scanner)
8.3. Pregnancy
8.4. Taking medication that may influence brain function

Recruitment start date

01/07/2012

Recruitment end date

30/06/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nuffield Orthopaedic Centre
Oxford
OX3 7LD
United Kingdom

Trial participating centre

32 recruiting centres
-
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Clinical Trials and Research Governance (CTRG)
Joint Research Office
Block 60 Churchill Hospital
Headington
OX3 7LJ
United Kingdom
-
heather.house@admin.ox.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Arthritis Research UK (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25956385

Publication citations

Additional files

Editorial Notes