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
Protocol serial number	H0526
Sponsor	Arthritis Research Campaign (ARC) (UK)
Funder	Arthritis Research Campaign

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	local corticosteroid injections, standard non-steroidal anti-inflammatory drugs and simple analgesics
Primary outcome measure(s)	Participants' global assessment of improvement (5-point scale) at 4 weeks.
Key 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
Completion date	31/12/1998

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	70 Years
Sex	Not Specified
Target sample size at registration	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

Department of Rheumatology

Stoke-on-Trent
ST6 7AG
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	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