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NCT Number: NCT06788158

Clinical Effects of Incobotulinum Toxin vs Corticosteroid in 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.

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Key information

Conditions

Plantar Fasciitis of Both Feet Fasciitis Fasciitis, Plantar Foot Diseases Function Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Mérida, Yucatán, 97000, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age over 18 years.
  • Any sex.
  • 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.
  • Voluntary acceptance of participation in the study.
  • Patients entitled to the Mexican Social Security Institute.

Exclusion criteria

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

Treatment and study plan

Incobotulinum Toxin A

Drug

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

Drug

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).

Primary outcomes

  1. 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

  2. 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.

  3. 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

  4. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Instituto Mexicano del Seguro Social

Other Gov

Registry information

Official study title

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

Acronym: fascitis

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 23, 2025
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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