Contact information
Type
Scientific
Primary contact
Mr Howard Kwong
ORCID ID
Contact details
Orthopaedic Department
Hospital of St Cross
Barby Road
Rugby
CV22 5PX
United Kingdom
+44 (0)1788 572831/545240
htkwong@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0295132803
Study information
Scientific title
Acronym
Study hypothesis
Compare the effects of subacromial injection of Tenoxicam (NSAID) with Depo-medrone (steroid) in patients with impingement syndrome.
Ethics approval
Added as of 27/03/2008:
1. Warwick Research Ethics Committee (REC) (ref: RE553)
2. Coventry REC (ref: 020/09/03)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
15/02/2004
Overall trial end date
17/07/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Number of participants recruited as of 27/03/2008: 58. At time of registration: 126.
Participant 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
Recruitment start date
15/02/2004
Recruitment end date
17/07/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Orthopaedic Department
Rugby
CV22 5PX
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
University Hospitals Coventry and Warwickshire NHS Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20044683
Publication citations
-
Results
Karthikeyan S, Kwong HT, Upadhyay PK, Parsons N, Drew SJ, Griffin D, A double-blind randomised controlled study comparing subacromial injection of tenoxicam or methylprednisolone in patients with subacromial impingement., J Bone Joint Surg Br, 2010, 92, 1, 77-82, doi: 10.1302/0301-620X.92B1.22137.