EFFICACY OF CORTICOIDS VS BOTULINIC TOXIN IN THE TREATMENT OF PLANTAR FASCITIS

Phase 1

• Conditions: Plantar fasciitis; Therapeutic area: Body processes [G] - Physical Phenomena [G01]

• Registration Number: EUCTR2018-002929-36-ES
• Lead Sponsor: Dra. Virginia Raquel Céspedes Nava

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-17
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

-EVA = 6.
-Over 18 years.
-Being able to read and write in Spanish.
-Diagnosticated plantar fasciitis with clinical symptoms of 3 months or more in duration.
- Written informed consent of the patients
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

-Patients who have suffered serious infectious processes or serious injuries to the feet in the last 6 months.
-Patients with serious systemic diseases.
-Patients with active oncological diseases.
-Patients in which the use of botulinum toxin or corticoids is contraindicated according to the respective technical data sheets.
-Pregnant or nursing patients.
-Patients who cannot answer the questionnaires properly.
-Previous treatment with botulinum toxin, in any of its preparations, without clinical response.
-Patients that have been infiltrated in the affected foot previously.
-Patients who have undergone surgery in the affected region in the 6 months prior to inclusion.
-Patients with bilateral plantar fasciitis.
-Patients anticoagulated.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy of treatment with corticosteroids vs botulinum toxin in plantar fasciitis (EVA scale at 1 and 3 months after treatment).;<br> Secondary Objective: To compare the following parameters between both treatments:<br> -Efficacy of treatment with corticosteroids vs botulinum toxin in plantar fasciitis (EVA scale at 7-10 days and at 6 months after treatment).<br> -Quality of life (SF36)<br> -Consumption of analgesics<br> -Security and tolerability<br> ;Primary end point(s): Pain: Variation in the EVA scale (0-10);Timepoint(s) of evaluation of this end point: At month and 3 months after treatment.

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): - Effect to other times different from the infiltration of drugs<br> - Quality of life: Questionnaire SF36 <br> - Presence of ultrasound findings: variations in the thickness of the plantar fascia or echogenicity <br> - Consumption of analgesics for plantar fasciitis for which a regular analgesic medication diary is provided<br> ;<br> Timepoint(s) of evaluation of this end point: 1st secondary end point: at 7-10 days to assess possible complications after treatment and at 6 months to assess the maintenance of the treatment effect.<br> 2st secondary end point: at month, 3 months and 6 months after treatment.<br> 3st secondary end point: at month 3 and 6 months after treatment.<br> 4st secondary end point: throughout treatment<br>