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| A randomised placebo-controlled trial of local steroid injection and nonsteroidal anti-inflammatory tablets for the treatment of tennis elbow |
| Source of record | UK Trials |
| ISRCTN | ISRCTN34466933 |
| Date ISRCTN assigned | 03/01/2003 |
| Local reference number(s) | H0526 |
| Public title | A randomised placebo-controlled trial of local steroid injection and nonsteroidal anti-inflammatory tablets for the treatment of tennis elbow |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Tennis elbow |
| Study hypothesis | 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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. |
| Participants - 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 |
| Patient information material | |
| Anticipated start date | 01/11/1995 |
| Anticipated end date | 31/12/1998 |
| Status of trial | Completed |
| Target number of participants | 164 |
| Interventions | 1. Methyl prednisolone (20 mg) and lignocaine by local injection 2. Naproxen 500 mg bd for 2 weeks versus placebo tablets |
| Primary outcome measure(s) | Participants' global assessment of improvement (5-point scale) at 4 weeks. |
| Secondary outcome measure(s) | 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 |
| Publications | Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=10514160 http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11932058 http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12019587 |
| Sources of funding | Arthritis Research Campaign |
| Sponsor name | Arthritis Research Campaign (UK) |
| Sponsor details | Copeman House St Mary's Court St Mary's Gate Chesterfield Derbyshire United Kingdom S41 7TD |
| Sponsor email | info@arc.org.uk |
| Sponsor website | http://www.arc.org.uk |
| Contact name | Dr EM Hay |
| Contact details | Department of Rheumatology Haywood Hospital High Lane Burslem Stoke-on-Trent United Kingdom ST6 7AG |
| Contact telephone | +44 (0)1782 715444 |
| Contact email | e.m.hay@cphc.keele.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN34466933 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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