Condition category
Musculoskeletal Diseases
Date applied
03/01/2003
Date assigned
03/01/2003
Last edited
03/08/2007
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

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

http://www.arc.org.uk

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes