Shoulder Injection Trial - A comparison of injection of Tenoxicam with Depo-Medrone in shoulders with subacromial impingement syndrome
| ISRCTN | ISRCTN61749398 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61749398 |
| Secondary identifying numbers | N0295132803 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 13/04/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Howard Kwong
Scientific
Scientific
Orthopaedic Department
Hospital of St Cross
Barby Road
Rugby
CV22 5PX
United Kingdom
| Phone | +44 (0)1788 572831/545240 |
|---|---|
| htkwong@hotmail.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Compare the effects of subacromial injection of Tenoxicam (NSAID) with Depo-medrone (steroid) in patients with impingement syndrome. |
| Ethics approval(s) | Added as of 27/03/2008: 1. Warwick Research Ethics Committee (REC) (ref: RE553) 2. Coventry REC (ref: 020/09/03) |
| Health condition(s) or problem(s) studied | Musculoskeletal Diseases: Shoulder disorders |
| Intervention | Please note that, as of 27/03/2008, the end date of this trial was updated from 30/09/2004 to 17/07/2006 (date on which the last participant was recruited). Interventions added as of 27/03/2008: The participants were randomly allocated to the following two arms in equal numbers: Arm 1: Subacromial injection of tenoxicam (NSAID) 20 mg single dose Arm 2: Subacromial injection of depo-medrone (steroid) 40 mg single dose |
| Intervention type | Other |
| Primary outcome measure | Primary outcome measures updated as of 27/03/2008: Constant-Murley shoulder assessment score at baseline and 6 weeks Primary outcome measures provided at time of registration: Constant-Murley Shoulder assessment score and Disabilities of the Arm Shoulder and Hand (DASH) Questionnaire. |
| Secondary outcome measures | Added as of 27/03/2008: 1. Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire at baseline and 2, 4 and 6 weeks 2. Oxford shoulder score at baseline and 2, 4 and 6 weeks |
| Overall study start date | 15/02/2004 |
| Completion date | 17/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Number of participants recruited as of 27/03/2008: 58. At time of registration: 126. |
| Key inclusion criteria | Added as of 27/03/2008: 1. Patients over the age of 18 years 2. Clinical diagnosis of subacromial impingement syndrome 3. Symptoms lasting longer than 3 months |
| Key exclusion criteria | Added as of 27/03/2008: 1. Evidence of other pathology causing shoulder pain 2. Injection in the same shoulder within the previous 6 months 3. Patients taking regular systemic NSAIDs or steroids or in whom those drugs were contraindicated 4. If their present shoulder condition was the subject of any legal proceedings or insurance claims 5. Pregnant and breast-feeding mothers |
| Date of first enrolment | 15/02/2004 |
| Date of final enrolment | 17/07/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Orthopaedic Department
Rugby
CV22 5PX
United Kingdom
CV22 5PX
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
University Hospitals Coventry and Warwickshire NHS Trust
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 | 01/01/2010 | Yes | No |
