The Shoulder Window of Opportunity Study

ISRCTN	ISRCTN25817033
DOI	https://doi.org/10.1186/ISRCTN25817033
Protocol serial number	0705/789
Sponsor	West Yorkshire Primary Care Research and Development Unit (UK)
Funder	Arthritis UK (UK) - formerly Arthritis Research Campaign (ref: 17236)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Dickon Crawshaw
Scientific

Leeds General Infirmary
Physiotherapy Gymnasium
Great George Street
Leeds
LS1 3EX
United Kingdom

Phone	+44 (0)113 3923245
Email	dickon.crawshaw@nhs.net

Primary study design	Interventional
Study design	Two-arm 12-week randomised trial with observational follow-up to 24 weeks
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Corticosteroid
Primary outcome measure(s)	The shoulder pain and disability index (SPADI) at week 12 will be considered the primary outcome
Key secondary outcome measure(s)	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
Completion date	14/03/2009

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Leeds General Infirmary

Leeds
LS1 3EX
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes