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
Protocol serial number	N0295132803
Sponsor	Department of Health
Funder	University Hospitals Coventry and Warwickshire NHS Trust

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	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
Completion date	17/07/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	58
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

United Kingdom
England

Study participating centre

Orthopaedic Department

Rugby
CV22 5PX
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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