Effectiveness of Infiltrations in the Treatment of Plantar Fasciopathy
NCT ID: NCT06671223
Last Updated: 2024-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
200 participants
INTERVENTIONAL
2025-06-01
2026-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
Intervention group: They will receive corticosteroid infiltrations under ultrasound guidance.
Control group: They will receive conservative treatment that may include physiotherapy and recommendations for foot care, without infiltrations.
TREATMENT
SINGLE
Participants: Participants are not informed to which treatment group they have been assigned (corticosteroid infiltrations or conservative treatment).
Investigators: Investigators evaluating clinical outcomes, including pain measurement and foot function, are blinded to the treatment group assignment of participants.
Healthcare Providers: The professionals administering the infiltrations are masked regarding treatment assignment, as a third party, not involved in the study, will be responsible for performing the infiltrations.
Data Monitors: Data monitors monitoring the safety and integrity of the study are also blinded to treatment assignments until final analysis of the results is completed.
Study Groups
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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.
Infiltration
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.
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.
Conservative treatment
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.
Interventions
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Infiltration
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.
Conservative treatment
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
50 Years
ALL
No
Sponsors
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University of Seville
OTHER
Responsible Party
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ANA MARIA RAYO PEREZ
Principal Investigator
Locations
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Universidad de Sevilla
Seville, , Spain
Countries
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Central Contacts
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ANA MARIA RP DRA. ANA MARIA RAYO PEREZ, PRINCIPAL INVESTIGATOR
Role: CONTACT
RAQUEL GDP DRA. RAQUEL GARCIA DE LA PEÑA, PhD in Podiatry Science
Role: CONTACT
Facility Contacts
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Other Identifiers
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TFMAGM2024
Identifier Type: OTHER
Identifier Source: secondary_id
TFMAGM
Identifier Type: -
Identifier Source: org_study_id
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