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

Orthopaedic Department
Hospital of St Cross
Barby Road
Rugby
CV22 5PX
United Kingdom

Phone +44 (0)1788 572831/545240
Email htkwong@hotmail.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesCompare 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) studiedMusculoskeletal Diseases: Shoulder disorders
InterventionPlease 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 typeOther
Primary outcome measurePrimary 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 measuresAdded 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 date15/02/2004
Completion date17/07/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsNumber of participants recruited as of 27/03/2008: 58. At time of registration: 126.
Key inclusion criteriaAdded 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 criteriaAdded 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 enrolment15/02/2004
Date of final enrolment17/07/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Orthopaedic Department
Rugby
CV22 5PX
United Kingdom

Sponsor information

Department of Health
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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