Clinical Effects of Incobotulinum Toxin vs Corticosteroid in Plantar Fascitis (fascitis)

January 20, 2025 updated by: Roberto Carlos Pech Arguelles, Instituto Mexicano del Seguro Social

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Yucatán
      • Mérida, Yucatán, Mexico, 97000
        • Hospital General Regional No.1 "Lic. Ignacio García Téllez" IMSS, Calle 41 101, Fénix, 97155 Mérida, Yuc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: incobotulinum toxin + rehabilitation
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: 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).
Active Comparator: glucocorticoid + rehabilitation
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).
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Pain Scale
Time Frame: Initially, 4, 8 and 16 weeks.
zero is equivalent to no pain and 10 indicates the worst possible pain
Initially, 4, 8 and 16 weeks.
Clinical Functional Status of the Ankle and Foot
Time Frame: Initially, 4, 8 and 16 weeks.
Result of the total summative score of the American Foot and Ankle Society Scale, Excellent=90-100, Good =80-89, Medium=70-79, Poor=<70.
Initially, 4, 8 and 16 weeks.
Index of Functional Disability of the Foot and Ankle in Activities of Daily Living
Time Frame: Initially, 4, 8 and 16 weeks.
Result of the total summative score of the Ankle disability index scale. Absence of disability or pain = 100 Mild=80-99 Moderate=50-79 Severe:1-49 Maximum disability level = 0
Initially, 4, 8 and 16 weeks.
Index of Functional Disability of the Foot and Ankle in Sports Activities
Time Frame: Initially, 4, 8 and 16 weeks.
Result of the total summative score of the ankle disability index scale. Absence of disability or pain = 100 Mild=80-99 Moderate=50-79 Severe:1-49 Maximum disability level = 0
Initially, 4, 8 and 16 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mobility Arc
Time Frame: Initially and 16 weeks.
Range of motion (degree of travel) or total angular/axial displacement allowed at ankle joint, dosiflexion degrees at the time of data collection, will be expressed in the results by mobility range groups according to the American Academy of Orthopedic Surgeons AAOS.
Initially and 16 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Mexicano del Seguro Social

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Actual)

January 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

January 3, 2025

First Submitted That Met QC Criteria

January 20, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 20, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-2024-3201-115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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