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NCT Number: NCT06671223

Effectiveness of Infiltrations in the Treatment of Plantar Fasciopathy

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Sevilla

Seville, 41009, Spain

Location contact

RAQUEL GDP DRA. RAQUEL GARCIA DE LA PEÑA, PhD in Podiatry Science

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Infiltration

Drug

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: Intervention group

Conservative treatment

Other

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: Control group

Primary outcomes

  1. 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.

    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).

Secondary outcomes

  1. Functional Improvement

    Time frame: Evaluations at the beginning, and at 3, 6 and 12 weeks post-intervention.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

ANA MARIA RP DRA. ANA MARIA RAYO PEREZ, PRINCIPAL INVESTIGATOR

CONTACT

[email protected]

034-955-841-656 ext. +34

RAQUEL GDP DRA. RAQUEL GARCIA DE LA PEÑA, PhD in Podiatry Science

CONTACT

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Registry information

Official study title

Effectiveness of Infiltrations in the Treatment of Plantar Fasciopathy: A Randomized Clinical Study.

Acronym: INFILTRA-PLANT

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Nov 4, 2024
Registry last updated
Nov 4, 2024

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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