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The Shoulder Window of Opportunity Study (SWOP) - A pragmatic randomised trial comparing corticosteroid injection with timely physiotherapy with physiotherapy alone for older subjects with subacromial impingement syndrome and moderate to severe pain and disability. - The SWOP Study

The Shoulder Window of Opportunity Study (SWOP) - A pragmatic randomised trial comparing corticosteroid injection with timely physiotherapy with physiotherapy alone for older subjects with subacromial impingement syndrome and moderate to severe pain and disability. - The SWOP Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-003628-20-GB
Enrollment
220
Registered
2005-09-12
Start date
2005-11-10
Completion date
Unknown
Last updated
2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subacromial impingement syndrome

Interventions

Trade Name: Kenalog Intra-articular / Intramuscular Injection Product Name: triamcinolone acetonide Pharmaceutical Form: Suspension for injection INN or

Sponsors

West Yorkshire Primary Care R&D Unit
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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. 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 (van der Windt 1998 25). Some loss of lateral rotation permitted but no more than 25% compared to opposite side. 4. Positive impingement test (Hawkins or Neer). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 breast feeding 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.

Design outcomes

Primary

MeasureTime frame
Main Objective: 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. ; Secondary Objective: 1. To investigate effects of the therapies on subject quality of life. 2. To ascertain if any improvement in both groups is maintained at 24 weeks. 3. To monitor additional interventions from 12-24 weeks. ;Primary end point(s): The shoulder pain and disability index (SPADI) has been shown to be a reliable and valid outcome measure. The SPADI at week 12 will be considered the primary outcome

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026