A randomised placebo-controlled trial of local steroid injection and nonsteroidal anti-inflammatory tablets for the treatment of tennis elbow

ISRCTN ISRCTN34466933
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

Department of Rheumatology
Haywood Hospital
High Lane
Burslem
Stoke-on-Trent
ST6 7AG
United Kingdom

Phone +44 (0)1782 715444
Email e.m.hay@cphc.keele.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Scientific title
Study objectivesTo 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) studiedTennis elbow
Intervention1. Methyl prednisolone (20 mg) and lignocaine by local injection
2. Naproxen 500 mg bd for 2 weeks versus placebo tablets
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)local corticosteroid injections, standard non-steroidal anti-inflammatory drugs and simple analgesics
Primary outcome measureParticipants' global assessment of improvement (5-point scale) at 4 weeks.
Secondary outcome measures1. 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 date01/11/1995
Completion date31/12/1998

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit70 Years
SexNot Specified
Target number of participants164
Key inclusion criteriaConsecutive 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 criteria1. 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 enrolment01/11/1995
Date of final enrolment31/12/1998

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Rheumatology
Stoke-on-Trent
ST6 7AG
United Kingdom

Sponsor information

Arthritis Research Campaign (ARC) (UK)
Charity

Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom

Email info@arc.org.uk
Website http://www.arc.org.uk
ROR logo "ROR" https://ror.org/02jkpm469

Funders

Funder type

Charity

Arthritis Research Campaign

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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