Submission date
12/09/2003
Registration date
12/09/2003
Last edited
15/05/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Retrospectively registered
? Protocol not yet added
? SAP not yet added
Results added
? Raw data not yet added
Study completed

Plain English Summary

Not provided at time of registration

Study website

Contact information

Type

Scientific

Contact name

Dr Cathy Speed

ORCID ID

Contact details

Box No 204
Department of Rheumatology
Addenbrooke's NHS Trust
Hills Road
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 586518
cathy.speed@btinternet.com

Additional identifiers

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

N0544093542

Study information

Scientific title

Acronym

Study hypothesis

Ultrasound in plantar fasciitis.

Ethics approval(s)

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Not specified

Study 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: Plantar fasciitis

Intervention

To evaluate the effects of ultrasound in the treatment of plantar fasciitis. Adult subjects with plantar fasciitis 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 4 months from baseline. These will include an ankle and foot score and pain (primary measures), isokinetic strength of ankle plantar flexion and dorsifexion, 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

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall study start date

12/10/2000

Overall study end date

12/10/2003

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

200 (PROJ)

Participant type(s)

Patient

Age group

Not Specified

Sex

Not Specified

Target number of participants

200

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

12/10/2000

Recruitment end date

12/10/2003

Locations

Countries of recruitment

England, United Kingdom

Study 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

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2003 Yes No

Additional files

Editorial Notes