Is the use of bupivacaine hydrochloride 0.5% an effective treatment for the relief of chronic plantar fascial pain?

ISRCTN	ISRCTN86484960
DOI	https://doi.org/10.1186/ISRCTN86484960
Protocol serial number	N0265105806
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funders	University Hospital Birmingham NHS Trust, NHS R&D Support Funding

Submission date: 29/09/2006
Registration date: 29/09/2006
Last edited: 06/03/2015

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

Mr KM Porter
Scientific

Trauma
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Is the use of bupivacaine hydrochloride 0.5% an effective treatment for the relief of chronic plantar fascial pain?
Study objectives	Injection(s) of bupivacaine hydrochloride 0.5% is an effective treatment for patients with chronic plantar fascial pain.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Bupivacaine hydrochloride
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	26/02/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	80
Key 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.
Key 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
Date of first enrolment	26/02/2002
Date of final enrolment	26/02/2008

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Selly Oak Hospital

Birmingham
B29 6JD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan