Effectiveness of Infiltrations in the Treatment of Plantar Fasciopathy (INFILTRA-PLANT)
October 31, 2024 updated by: ANA MARIA RAYO PEREZ, University of Seville
Effectiveness of Infiltrations in the Treatment of Plantar Fasciopathy: A Randomized Clinical Study.
This clinical study aims to evaluate the effectiveness of infiltrations in the treatment of plantar fasciopathy, a painful condition that affects the sole of the foot and is common in active people.
Plantar fasciopathy is caused by inflammation or damage to the plantar fascia, the tissue that connects the heel to the toes.
Participants in this study will be randomly assigned to receive one of two treatments: corticosteroid infiltrations or conservative treatment without infiltrations.
Infiltrations will be guided by ultrasound to ensure accuracy.
The study will evaluate pain reduction and improvement in foot function over a six-month period.
The objective of the study is to determine if infiltrations provide a significant improvement compared to other non-invasive treatments.
The results will help doctors and patients make informed decisions about the best treatment options for plantar fasciopathy.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Detailed Description
This clinical study, titled "Effectiveness of Infiltrations in the Treatment of Plantar Fasciopathy", will be carried out at the University of Seville and its main objective is to evaluate the impact of corticosteroid infiltrations on pain reduction and functional improvement in patients diagnosed with plantar fasciopathy.
Study Type
Interventional
Enrollment (Estimated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: ANA MARIA RP DRA. ANA MARIA RAYO PEREZ, PRINCIPAL INVESTIGATOR
- Phone Number: +34 034-955-841-656
- Email: anarayo43@gmail.com
Study Contact Backup
- Name: RAQUEL GDP DRA. RAQUEL GARCIA DE LA PEÑA, PhD in Podiatry Science
Study Locations
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Sevilla, Spain, 41009
- Universidad de Sevilla
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Contact:
- RAQUEL GDP DRA. RAQUEL GARCIA DE LA PEÑA, PhD in Podiatry Science
- Email: raquelgp@us.es
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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
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Age: Participants aged 18 to 50 years. Diagnosis: Confirmed diagnosis of plantar fasciopathy based on clinical evaluation and imaging (if applicable).
Duration of Symptoms: Symptoms persisting for at least 6 weeks prior to enrollment.
Pain Level: Reported pain level of at least 4 on the Visual Analog Scale (VAS) at baseline.
Ability to Comply: Participants must be able to follow study protocols and attend follow-up appointments.
Informed Consent: Participants must provide written informed consent to participate in the study.
Exclusion Criteria:
Other Foot Pathologies: Presence of other significant foot conditions (e.g., fractures, arthritis, tarsal tunnel syndrome) that could interfere with the study results.
Pregnancy or Breastfeeding: Pregnant or breastfeeding individuals will be excluded from the study.
Neurological Disorders: History of significant neurological disorders affecting lower limb function.
Systemic Conditions: Patients with systemic conditions (e.g., diabetes, autoimmune diseases) that could affect healing or response to treatment.
Allergy to Corticosteroids: Known allergy or adverse reaction to corticosteroids or local anesthetics.
Psychiatric Disorders: Individuals with severe psychiatric disorders that may impair their ability to provide informed consent or adhere to the study protocol.
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: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Corticoesteroid Infiltrations
In this group, participants will receive infiltrations directly into the affected plantar fascia.
This intervention aims to reduce the inflammation and pain associated with plantar fasciopathy.
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The intervention consists of the administration of infiltrations in the affected plantar fascia of participants with a diagnosis of plantar fasciopathy.
A drug such as a corticosteroid, PRP or hyaluronic acid will be used, which will be injected under ultrasound guidance to ensure precision at the site of the injury.
This intervention aims to reduce inflammation and pain, thus improving the functionality of the foot.
Up to three infiltrations will be performed, depending on the patient's response to treatment and medical evaluation.
The infiltrations will be compared with a control group that will receive conservative treatment without infiltrations, to evaluate the relative effectiveness of this pharmacological intervention in the management of plantar fasciopathy.
Other Names:
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Placebo Comparator: Conservative treatment
Participants in this group will receive conservative treatment that does not include infiltrations.
This approach is based on non-invasive methods that are commonly used to manage plantar fasciopathy.
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The control group is used to compare the effectiveness of infiltrations with a non-invasive approach in the treatment of plantar fasciopathy.
This group will not receive any infiltration and will focus on conservative interventions.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Pain Level
Time Frame: Evaluations will be carried out at the beginning of the study, and at 3, 6 and 12 weeks after the intervention.
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Pain level will be assessed using the Visual Analogue Scale 0 to 10 points (VAS), where participants will mark their pain level on a 10 cm line, from "no pain" (0) to "unbearable pain" (10).
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Evaluations will be carried out at the beginning of the study, and at 3, 6 and 12 weeks after the intervention.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Functional Improvement
Time Frame: Evaluations at the beginning, and at 3, 6 and 12 weeks post-intervention.
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Foot functionality will be assessed using the Foot Function Index 0 to 100 points (FFI), which measures the functional capacity of the foot and the impact of pain on daily activities.
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Evaluations at the beginning, and at 3, 6 and 12 weeks post-intervention.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Estimated)
June 1, 2025
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
September 26, 2024
First Submitted That Met QC Criteria
October 31, 2024
First Posted (Estimated)
November 4, 2024
Study Record Updates
Last Update Posted (Estimated)
November 4, 2024
Last Update Submitted That Met QC Criteria
October 31, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TFMAGM
- TFMAGM2024 (Other Identifier: Universidad de Sevilla)
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
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