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

ISRCTN ISRCTN71865873
DOI https://doi.org/10.1186/ISRCTN71865873
Secondary identifying numbers N0544093511
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
31/10/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Cathy Speed
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleUltrasound therapy for medial epicondylitis. A double blind randomised placebo controlled trial.
Study objectivesUltrasound therapy for medial epicondylitis
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedMusculoskeletal Diseases: Medial epicondylitis
InterventionTo 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 typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date11/09/2000
Completion date11/09/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
Lower age limit18 Years
Upper age limit75 Years
SexNot Specified
Target number of participants200
Key inclusion criteria200 Adults aged 18-75 (PROJ).
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment11/09/2000
Date of final enrolment11/09/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Box No 204
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Other

Cambridge Consortium - Addenbrooke's (UK)

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

Editorial Notes

31/10/2019: No publications found in PubMed, verifying study status with principal investigator.
13/10/2017: No publications found in PubMed, verifying study status with principal investigator.