Condition category
Musculoskeletal Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
06/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr KM Porter

ORCID ID

Contact details

Trauma
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes