A randomised placebo-controlled trial of local steroid injection and nonsteroidal anti-inflammatory tablets for the treatment of tennis elbow
ISRCTN | ISRCTN34466933 |
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DOI | https://doi.org/10.1186/ISRCTN34466933 |
Secondary identifying numbers | H0526 |
- Submission date
- 03/01/2003
- Registration date
- 03/01/2003
- Last edited
- 03/08/2007
- 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
Dr EM Hay
Scientific
Scientific
Department of Rheumatology
Haywood Hospital
High Lane
Burslem
Stoke-on-Trent
ST6 7AG
United Kingdom
Phone | +44 (0)1782 715444 |
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e.m.hay@cphc.keele.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | GP practice |
Study type | Treatment |
Scientific title | |
Study objectives | To compare the clinical effectiveness of local corticosteroid injections, standard non-steroidal anti-inflammatory drugs and simple analgesics for the treatment of lateral epicondylitis in primary care. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Tennis elbow |
Intervention | 1. Methyl prednisolone (20 mg) and lignocaine by local injection 2. Naproxen 500 mg bd for 2 weeks versus placebo tablets |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | local corticosteroid injections, standard non-steroidal anti-inflammatory drugs and simple analgesics |
Primary outcome measure | Participants' global assessment of improvement (5-point scale) at 4 weeks. |
Secondary outcome measures | 1. Pain severity 2. Impairment of function 3. Severity of main complaint 4. Disability 5. Grip strength 6. Local tenderness 7. Co-interventions 8. Time off paid employment |
Overall study start date | 01/11/1995 |
Completion date | 31/12/1998 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 70 Years |
Sex | Not Specified |
Target number of participants | 164 |
Key inclusion criteria | Consecutive patients aged 18-70 years who consulted their GP with a new episode of lateral epicondylitis (pain and tenderness in the lateral region of the elbow and no consultation with symptoms in the same elbow in the preceding 12 months) during November 1995 to December 1997. |
Key exclusion criteria | 1. History of inflammatory arthritis or gross structural abnormality of the elbow 2. Contraindications to non-steroidal anti-inflammatories or local steroid injection 3. Pregnancy or breast feeding |
Date of first enrolment | 01/11/1995 |
Date of final enrolment | 31/12/1998 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Rheumatology
Stoke-on-Trent
ST6 7AG
United Kingdom
ST6 7AG
United Kingdom
Sponsor information
Arthritis Research Campaign (ARC) (UK)
Charity
Charity
Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom
info@arc.org.uk | |
Website | http://www.arc.org.uk |
https://ror.org/02jkpm469 |
Funders
Funder type
Charity
Arthritis Research Campaign
No information available
Results and Publications
Intention to publish date | |
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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 | 09/10/1999 | Yes | No | |
Abstract results | 01/03/2002 | No | No | ||
Abstract results | 01/04/2002 | No | No |