Effectiveness of Infiltrations in the Treatment of Plantar Fasciopathy

Not Applicable

Not yet recruiting

• Conditions: Plantar Fasciitis of Both Feet; Plantar Fasciopathy
• Interventions: Drug: Infiltration; Other: Conservative treatment

• Registration Number: NCT06671223
• Lead Sponsor: University of Seville

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-09-26
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-31
• Last Update Submitted: 2024-10-31
• Study First Posted: 2024-11-04
• Last Update Posted: 2024-11-04
• Study Start: 2025-06-01
• Primary Completion: 2025-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Corticoesteroid Infiltrations	Infiltration	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.
Conservative treatment	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.

Primary Outcome Measures

Name	Time	Method
Change in Pain Level	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 Outcome Measures

Name	Time	Method
Functional Improvement	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.

Trial Locations

Locations (1)

Universidad de Sevilla; 🇪🇸 Sevilla, Spain