Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0265105806
Study information
Scientific title
Is the use of bupivacaine hydrochloride 0.5% an effective treatment for the relief of chronic plantar fascial pain?
Acronym
Study hypothesis
Injection(s) of bupivacaine hydrochloride 0.5% is an effective treatment for patients with chronic plantar fascial pain.
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
Treatment
Patient information sheet
Condition
Musculoskeletal Diseases: Plantar fasciitis
Intervention
It is proposed that 80 subjects presenting with heel Pain that have been referred for Podiatric assessment and intervention will be recruited to the study.
Those patients who are diagnosed with plantar fasciitis according to a recognised criteria, and who consent to the study, will have their pain intensity assessed using a Visual Analogue Scale (VAS).
The patients will then be randomized into experimental and control groups. The recruits will then receive the proposed treatment regime and will have their VAS assessed at each visit.
The researcher will remain blind to the recruits VAS score and both the researcher and subject will be blind to the injected agent. The use of local anesthetic injections as a therapeutic intervention is normal practice within the Podiatry department.
Intervention type
Drug
Phase
Not Applicable
Drug names
Bupivacaine hydrochloride
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
26/02/2002
Overall trial end date
26/02/2008
Reason abandoned
Eligibility
Participant inclusion criteria
The cohort of patients will be recruited from appropriate referrals received from General Practitioners within Primary Care, and Consultants within the UHB Trust for Podiatric assessment and intervention.
Volunteers will be provided with information sheets and informed consent required in writing will be obtained prior to the study. Volunteers will be made aware that their withdrawal form the study at any stage will not adversely affect their future treatment.
Inclusion criteria: Patients over 18 years of age with pain over the medial aspect of the heel, and who fulfill the criteria set down by Saxelby et al (1997).
The Podiatry Department has access to interpreters if there are issues relating to language problems.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant exclusion criteria
1. Patients with a known sensitivity to local anesthetics
2. Patents with liver disease
3. Patients with kidney disease
4. Patients with broken skin/skin lesions/infection around the injection site
5. Pregnant women
6. Patients on anticoagulation therapy
Recruitment start date
26/02/2002
Recruitment end date
26/02/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Selly Oak Hospital
Birmingham
B29 6JD
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
University Hospital Birmingham NHS Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
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