Condition category
Musculoskeletal Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
06/12/2013
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 Cathy Speed

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0544103837

Study information

Scientific title

Acronym

Study hypothesis

Ultrasound therapy for lateral 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

Condition

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

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 18-75 year olds (PROJ)

Participant type

Patient

Age group

Adult

Gender

Both

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

http://www.doh.gov.uk

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

2006 results in: http://www.ncbi.nlm.nih.gov/pubmed/16303817

Publication citations

  1. Results

    D'Vaz AP, Ostor AJ, Speed CA, Jenner JR, Bradley M, Prevost AT, Hazleman BL, Pulsed low-intensity ultrasound therapy for chronic lateral epicondylitis: a randomized controlled trial., Rheumatology (Oxford), 2006, 45, 5, 566-570, doi: 10.1093/rheumatology/kei210.

Additional files

Editorial Notes