Condition category
Injury, Occupational Diseases, Poisoning
Date applied
07/03/2006
Date assigned
11/05/2006
Last edited
08/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Dickon Crawshaw

ORCID ID

Contact details

Leeds General Infirmary
Physiotherapy Gymnasium
Great George Street
Leeds
LS1 3EX
United Kingdom
+44 (0)113 3923245
dickon.crawshaw@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

0705/789

Study information

Scientific title

Acronym

SWOPS

Study hypothesis

To investigate whether a combined approach of physiotherapy with subacromial corticosteroid injection is more effective in reducing pain and disability at 12 weeks than physiotherapy alone in older patients with moderate to severe shoulder pain due to subacromial impingement syndrome.

Ethics approval

Approved by the Leeds (West) Research Ethics Committee on 31/10/05, project reference 05/Q1205/174

Study design

Two-arm 12-week randomised trial with observational follow-up to 24 weeks

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Subacromial impingement syndrome

Intervention

Participants are randomised to receive one of the following treatments:
1. Subacromial corticosteroid (triamcinolone acetonide) injection combined with a standardised physiotherapy regimen
2. Standardised physiotherapy regimen alone

Intervention type

Drug

Phase

Not Specified

Drug names

Corticosteroid

Primary outcome measures

The shoulder pain and disability index (SPADI) at week 12 will be considered the primary outcome

Secondary outcome measures

1. Participant global assessment of change from baseline will be recorded using a five-point scale
2. Overall health status will be recorded using the Euroqol
3. Information on use of therapeutic interventions from weeks 12 to 24 will be recorded

Overall trial start date

14/03/2006

Overall trial end date

14/03/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 40 years or older with unilateral shoulder pain. Shoulder pain is defined as pain in the shoulder region, including the upper arm, elicited or exacerbated by active or passive shoulder movement.br/>2. Subject rating of pain as moderate or severe on a 3-point scale (mild/moderate/severe)
3. Non-capsular pattern of restriction where capsular pattern is defined as painful and limited passive glenohumeral mobility, lateral rotation must be relatively more restricted than abduction and medial rotation. Some loss of lateral rotation permitted but no more than 25% compared to opposite side.
4. Positive impingement test (Hawkins or Neer)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

220

Participant exclusion criteria

1. Unable to give informed consent
2. Known blood coagulation disorders
3. Evidence of referred pain from the cervical spine or internal organs
4. Neurological abnormality of the shoulder
5. History of rheumatoid arthritis, polymyalgia rheumatica or other inflammatory arthritis
6. Bilateral shoulder pain
7. Contraindications to local steroid/lidocaine injection
8. Pregnancy or breastfeeding
9. Previous fracture, dislocation or surgery to shoulder, upper limb, neck, or thorax
10. No previous steroid injections in the symptomatic shoulder in the previous 6 months
11. No previous physiotherapy for the symptomatic shoulder in the previous 6 months

Recruitment start date

14/03/2006

Recruitment end date

14/03/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom

Sponsor information

Organisation

West Yorkshire Primary Care Research and Development Unit (UK)

Sponsor details

Bradford South and West Primary Care Trust
Allerton Health Centre
Bell Dean Road
Bradford
BD15 7NJ
United Kingdom
sally-anne.pearson@bradford.nhs.uk

Sponsor type

Government

Website

Funders

Funder type

Charity

Funder name

Arthritis UK (UK) - formerly Arthritis Research Campaign (ref: 17236)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20584793
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23630367

Publication citations

  1. Results

    Jowett S, Crawshaw DP, Helliwell PS, Hensor EM, Hay EM, Conaghan PG, Cost-effectiveness of exercise therapy after corticosteroid injection for moderate to severe shoulder pain due to subacromial impingement syndrome: a trial-based analysis., Rheumatology (Oxford), 2013, 52, 8, 1485-1491, doi: 10.1093/rheumatology/ket149.

  2. Crawshaw DP, Helliwell PS, Hensor EM, Hay EM, Aldous SJ, Conaghan PG, Exercise therapy after corticosteroid injection for moderate to severe shoulder pain: large pragmatic randomised trial., BMJ, 2010, 340, c3037.

Additional files

Editorial Notes