The Shoulder Window of Opportunity Study
| ISRCTN | ISRCTN25817033 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25817033 |
| Secondary identifying numbers | 0705/789 |
- Submission date
- 07/03/2006
- Registration date
- 11/05/2006
- Last edited
- 08/05/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Dickon Crawshaw
Scientific
Scientific
Leeds General Infirmary
Physiotherapy Gymnasium
Great George Street
Leeds
LS1 3EX
United Kingdom
| Phone | +44 (0)113 3923245 |
|---|---|
| dickon.crawshaw@nhs.net |
Study information
| 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 |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | SWOPS |
| Study objectives | 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(s) | Approved by the Leeds (West) Research Ethics Committee on 31/10/05, project reference 05/Q1205/174 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Corticosteroid |
| Primary outcome measure | 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 study start date | 14/03/2006 |
| Completion date | 14/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 220 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 14/03/2006 |
| Date of final enrolment | 14/03/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom
LS1 3EX
United Kingdom
Sponsor information
West Yorkshire Primary Care Research and Development Unit (UK)
Government
Government
Bradford South and West Primary Care Trust
Allerton Health Centre
Bell Dean Road
Bradford
BD15 7NJ
United Kingdom
| sally-anne.pearson@bradford.nhs.uk |
Funders
Funder type
Charity
Arthritis UK (UK) - formerly Arthritis Research Campaign (ref: 17236)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 28/06/2010 | Yes | No | |
| Results article | results | 01/08/2013 | Yes | No |
