Contact information
Type
Scientific
Primary contact
Dr EM Hay
ORCID ID
Contact details
Department of Rheumatology
Haywood Hospital
High Lane
Burslem
Stoke-on-Trent
ST6 7AG
United Kingdom
+44 (0)1782 715444
e.m.hay@cphc.keele.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
H0526
Study information
Scientific title
Acronym
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
local corticosteroid injections, standard non-steroidal anti-inflammatory drugs and simple analgesics
Primary outcome measures
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 trial start date
01/11/1995
Overall trial end date
31/12/1998
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
164
Participant 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
Recruitment start date
01/11/1995
Recruitment end date
31/12/1998
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Rheumatology
Stoke-on-Trent
ST6 7AG
United Kingdom
Sponsor information
Organisation
Arthritis Research Campaign (ARC) (UK)
Sponsor details
Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom
-
info@arc.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Arthritis Research Campaign
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
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
Publication citations
-
Results
Hay EM, Paterson SM, Lewis M, Hosie G, Croft P, Pragmatic randomised controlled trial of local corticosteroid injection and naproxen for treatment of lateral epicondylitis of elbow in primary care., BMJ, 1999, 319, 7215, 964-968.
-
Smidt N, Assendelft WJ, van der Windt DA, Hay EM, Buchbinder R, Bouter LM, Corticosteroid injections for lateral epicondylitis: a systematic review., Pain, 2002, 96, 1-2, 23-40.
-
Lewis M, Hay EM, Paterson SM, Croft P, Effects of manual work on recovery from lateral epicondylitis., Scand J Work Environ Health, 2002, 28, 2, 109-116.