The GRASP Trial - Getting it Right: Addressing Shoulder Pai
- Conditions
- Rotator Cuff Partial Tear (not full tear)MedDRA version: 19.0Level: LLTClassification code 10039226Term: Rotator cuff injurySystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2016-002991-28-GB
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 704
1) Men and women aged 18 years and above;
2) with a new episode of shoulder pain (i.e., within the last 6 months) attributable to a rotator cuff disorder (e.g., cuff tendonitis, impingement syndrome, tendinopathy or rotator cuff tear) using the diagnostic criteria set out in the BESS (British Shoulder and Elbow Society) guidelines;
3) who are not currently receiving physiotherapy;
4) who are not being considered for surgery; and
5) able to understand spoken and written English.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 104
1) Participants with a history of significant shoulder trauma (e.g., dislocation, fracture or full thickness tear requiring surgery);
2) those with a neurological disease affecting the shoulder;
3) those with other shoulder disorders (e.g., inflammatory arthritis, frozen shoulder, glenohumeral joint instability) or with red flags consistent with the criteria set out in the BESS guidelines;
4) those who have received corticosteroid injection or physiotherapy for shoulder pain in the last 6 months; and
5) those with contra-indications to corticosteroid injection.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method