NCT06788158

Clinical Effects of Incobotulinum Toxin vs Corticosteroid in Plantar Fascitis

Clinical Effects of the Intralesional Application of Incobotulinum Toxin vs Corticosteroid in Patients With Plantar Fascitis

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Instituto Mexicano del Seguro Social · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Plantar Fasciitis of Both Feet
• Pain
• Function

Interventions

Type	Name	Description
DRUG	Incobotulinum Toxin A	will be administered 2 ampoules (200 IU) of Incobotulinum toxin , injectable solution presentation 100 IU ampoule with powder diluted in 1 ml of 0.9% saline solution in a single application at 4 points, in addition to a therapeutic exercise program in the teaching service to later do it at home that will be done daily for 4 months (cryotherapy for 15 minutes on the plantar fascia, active mobilizations of the ankle and foot for 5 minutes, stretching exercises for the triceps surae and plantar fascia for 20 seconds, 3 repetitions, strengthening of intrinsic muscles of the foot).
DRUG	Glucocorticoid	Program in which 2 ml of dexamethasone will be administered in an 8 mg/2 ml ampoule diluted in 2 ml of lidocaine injectable solution in a 50 ml bottle (20 mg/ml) in a single application at 1 point, in addition to a therapeutic exercise program in the teaching service to later do it at home that will be done daily for 4 months (cryotherapy for 15 minutes on the plantar fascia, active mobilizations of the ankle and foot for 5 minutes, stretching exercises for the triceps surae and plantar fascia for 20 seconds, 3 repetitions, strengthening of intrinsic muscles of the foot).

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-01-01
• Completion: 2025-04-01
• First posted: 2025-01-23
• Last updated: 2025-01-23

Locations

1 site across 1 country: Mexico