Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0055166069
Study information
Scientific title
The use of topical glyceryl trinitrate (GTN) for the treatment of plantar fasciitis: a prospective double-blinded randomised trial
Acronym
Study hypothesis
Does the use of a topical GTN patch used with pressure relieving insoles and stretching exercises improve the symptoms of plantar fasciitis (heel pain) compared with current treatments?
Ethics approval
Not provided at time of registration
Study design
Double blinded randomised trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Muskuloskeletal Diseases: Plantar fasciitis
Intervention
One group will receive pressure relieving insoles and GTN patches, the other will receive pressure relieving insoles and placebo patches. Both groups will be instructed as to the use of the patches.
Intervention type
Drug
Phase
Not Applicable
Drug names
Topical glyceryl trinitrate
Primary outcome measure
Subjective, using questionnaires with visual analogue pain score
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/08/2005
Overall trial end date
30/07/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
2 groups of 40 patients with chronic heel pain.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/08/2005
Recruitment end date
30/07/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
North Cumbria Acute Hospitals NHS Trust
Carlisle
CA2 7HY
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
North Cumbria Acute Hospitals NHS Trust (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
Basic results (scientific)
Publication list