Clinical trial NCT06788158: Clinical Effects of Incobotulinum Toxin vs Corticosteroid in Plantar Fascitis
Official title: Clinical Effects of the Intralesional Application of Incobotulinum Toxin vs Corticosteroid in Patients With Plantar Fascitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Plantar Fasciitis of Both Feet
Pain
Function
Keywords: botulinum toxin
plantar fasciitis
corticosteroid
pain
foot functionality
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2025-01-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objectives: To evaluate the clinical effects of intralesional application of incobotulinum toxin vs corticosteroid in patients with plantar fasciitis .

Material and methods: Prospective, experimental, randomized, controlled clinical study; the population will be recruited in the outpatient clinic of the rehabilitation service meeting the inclusion criteria, two randomized study groups will be formed: GROUP A: Patients who accept intralesional infiltration with incobotulinum toxin . GROUP B: Patients who accept intralesional infiltration with dexamethasone.

Both groups will be assessed before application, at 1 month, at 2 and 4 months post intervention. The visual analogue scale (VAS), the American Orthopaedic Foot and Ankle Society (AOFAS) scale and the Foot and Ankle Disability Index (FADI) will be used to assess pain, foot functionality, functional disability index in activities of daily living, in physical activity and measurement of the dorsiflexion arch in 2 visits at the beginning of diagnosis and at 4 months, collecting the variables and establishing a hypothesis analysis to accept or discard normality criteria of the same with tendency and its significance in relation to p \<0.05 to establish contrast of the results with parametric or non-parametric variables according to whether or not the hypothesis of normality is discarded.

Detailed description: The investigators want to compare the effects on pain, ankle and foot functionality, as well as activities of daily living; of the application of incobotulinum toxin vs corticosteroid in people suffering from plantar fasciitis.

Eligibility criteria: Inclusion Criteria:

1. Age over 18 years.
2. Any sex.
3. Diagnosis of plantar fasciitis (pain in the medial plantar calcaneal tubercle which gives rise to the site of plantar fascial insertion into the heel bone and/or pain along the path of its three bands) made by a physician specializing in Physical Medicine and Rehabilitation.
4. Voluntary acceptance of participation in the study.
5. Patients entitled to the Mexican Social Security Institute.

Exclusion Criteria:

1. Diagnosis of ankylosing spondylitis.
2. Pregnant women.
3. Previous infiltration treatment with any medication or substance applied to the plantar fascia or gastrocnemius muscles in the last six months.
4. Anticoagulant treatment.
5. History of local infection in the plantar fascia in the last three months.
6. Allergic to lidocaine, incobotulinum toxin or dexamethasone.
7. Patients not entitled to the Mexican Social Security Institute.
8. Patient's refusal to participate in the study.

Primary outcomes:
measure: Visual Analogue Pain Scale
timeFrame: Initially, 4, 8 and 16 weeks.
measure: Clinical Functional Status of the Ankle and Foot
timeFrame: Initially, 4, 8 and 16 weeks.
measure: Index of Functional Disability of the Foot and Ankle in Activities of Daily Living
timeFrame: Initially, 4, 8 and 16 weeks.
measure: Index of Functional Disability of the Foot and Ankle in Sports Activities
timeFrame: Initially, 4, 8 and 16 weeks.
Secondary outcomes:
measure: Mobility Arc
timeFrame: Initially and 16 weeks.
Other outcomes:
Locations:
city: Mérida
country: Mexico
facility: Hospital General Regional No.1 "Lic. Ignacio García Téllez" IMSS, Calle 41 101, Fénix, 97155 Mérida, Yuc.
state: Yucatán
Study officials:
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