Plantar fasciitis
Conditions
Interventions
Trade Name: Xeomin®
Product Name: IncobotulinumtoxinA
Product Code: IncobotulinumtoxinA
Pharmaceutical Form: Powder for solution for injection
Sponsors
Dra. Virginia Raquel Céspedes Nava
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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).; Secondary Objective: To compare the following parameters between both treatments: -Efficacy of treatment with corticosteroids vs botulinum toxin in plantar fasciitis (EVA scale at 7-10 days and at 6 months after treatment). -Quality of life (SF36) -Consumption of analgesics -Security and tolerability ;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Effect to other times different from the infiltration of drugs - Quality of life: Questionnaire SF36 - Presence of ultrasound findings: variations in the thickness of the plantar fascia or echogenicity - Consumption of analgesics for plantar fasciitis for which a regular analgesic medication diary is provided ; 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. 2st secondary end point: at month, 3 months and 6 months after treatment. 3st secondary end point: at month 3 and 6 months after treatment. 4st secondary end point: throughout treatment | — |
Countries
Spain
Contacts
Public ContactDra. Virginia Raquel Céspedes Nava
Hospital Universitario Doce de Octubre
Outcome results
None listed