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 |
| Secondary identifying numbers | N0265105806 |
- 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
Scientific
Trauma
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Bupivacaine hydrochloride |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 26/02/2002 |
| Completion date | 26/02/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom
B29 6JD
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Hospital/treatment centre
University Hospital Birmingham NHS Trust
No information available
NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
