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NCT06788158

Clinical Effects of Incobotulinum Toxin vs Corticosteroid in Plantar Fascitis

StatusCompleted
PhasePhase 1
Primary completion
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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

  1. Notable Study completion date changed from estimate of Apr 1, 2025 to Nov 1, 2025 Show 5 more changesShow less
    • Trial completed
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised
    • Publications: details revised at 19 of 20 entries
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Visual Analogue Pain Scale
Timeframe: Initially, 4, 8 and 16 weeks.
Clinical Functional Status of the Ankle and Foot
Timeframe: Initially, 4, 8 and 16 weeks.
Index of Functional Disability of the Foot and Ankle in Activities of Daily Living
Timeframe: Initially, 4, 8 and 16 weeks.
Index of Functional Disability of the Foot and Ankle in Sports Activities
Timeframe: Initially, 4, 8 and 16 weeks.

Secondary (1)

Mobility Arc

Arms and interventions

incobotulinum toxin + rehabilitationExperimental

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).

glucocorticoid + rehabilitationActive comparator

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).

Drugs: Incobotulinum Toxin A, Glucocorticoid

Sites

1 site in 1 country

  • Hospital General Regional No.1 "Lic. Ignacio García Téllez" IMSS, Calle 41 101, Fénix, 97155 Mérida, Yuc.Mérida, Yucatán, Mexico