Condition category
Musculoskeletal Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
13/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20044683

Publication citations

  1. 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.

Additional files

Editorial Notes