Clinical trial NCT06671223: Effectiveness of Infiltrations in the Treatment of Plantar Fasciopathy
Official title: Effectiveness of Infiltrations in the Treatment of Plantar Fasciopathy: A Randomized Clinical Study.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Plantar Fasciitis of Both Feet
Plantar Fasciopathy
Keywords: plantar fasciitis
fasciopaty
corticosteroid
PRP
hyaluronic acid
infiltrations
treatment
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be randomly assigned to one of two groups:

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.
Primary purpose: TREATMENT

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 \&#34;Effectiveness of Infiltrations in the Treatment of Plantar Fasciopathy\&#34;, 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Pain Level
timeFrame: Evaluations will be carried out at the beginning of the study, and at 3, 6 and 12 weeks after the intervention.
Secondary outcomes:
measure: Functional Improvement
timeFrame: Evaluations at the beginning, and at 3, 6 and 12 weeks post-intervention.
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Universidad de Sevilla
Study officials:
References: