Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0544093511
Study information
Scientific title
Ultrasound therapy for medial epicondylitis. A double blind randomised placebo controlled trial.
Acronym
Study hypothesis
Ultrasound therapy for medial epicondylitis
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
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Musculoskeletal Diseases: Medial epicondylitis
Intervention
To evaluate the effects of ultrasound in the treatment of medial epicondylitis. Adult subjects with medial 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 all 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
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
11/09/2000
Overall trial end date
11/09/2003
Reason abandoned
Eligibility
Participant inclusion criteria
200 Adults aged 18-75 (PROJ).
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
200
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
11/09/2000
Recruitment end date
11/09/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Box No 204
Cambridge
CB2 2QQ
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Other
Funder name
Cambridge Consortium - Addenbrooke's (UK)
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