Ultrasound therapy for lateral epicondylitis. A double blind randomised placebo controlled trial

ISRCTN	ISRCTN34475330
DOI	https://doi.org/10.1186/ISRCTN34475330
Protocol serial number	N0544103837
Sponsor	Department of Health (UK)
Funder	Cambridge Consortium - Addenbrooke's (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Cathy Speed
Scientific

Box No 204
Department of Rheumatology
Addenbrooke's NHS Trust
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Ultrasound therapy for lateral epicondylitis
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Lateral epicondylitis (tennis elbow)
Intervention	To evaluate the effects of ultrasound in the treatment of lateral epicondylitis. Adult subjects with lateral epicondylitis will be randomised to receive either ultrasound (US) or sham (S) therapy. In the US group pulsed ultrasound will be delivered at a standardised dosage, initially five times weekly for 3 weeks, then three times weekly for 3 weeks. A single machine will be used and calibrated twice daily. The patient, assessor and treating clinician will be blinded. Outcome measures will be recorded at 6 weeks and at 9 months from baseline. These will include a forearm evaluation score and pain (primary measures), grip strength, flexibility, inflammation (thermographic score), quality of life and general health status, a summary item of status of the injury and a follow up transition item.
Intervention type	Other
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	11/09/2003

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	75 Years
Sex	All
Target sample size at registration	200
Key inclusion criteria	200 18-75 year olds (PROJ)
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	11/09/2000
Date of final enrolment	11/09/2003

Box No 204

Cambridge
CB2 2QQ
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	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2006		Yes	No