Outcome After Radial Pressure Wave Therapy in Plantar Fasciitis.

Completed

• Conditions: Fasciitis, Plantar; Fasciitis, Plantar, Chronic

• Registration Number: NCT06813105
• Lead Sponsor: Hospital Civil de Guadalajara

Brief Summary

The goal of this observational study is to explore potential associations between baseline patient characteristics (such as age, body mass index, and baseline pain intensity) and clinical outcomes in patients with plantar fasciitis undergoing radial pressure wave therapy (RPWT). The study includes male and female adults aged 18 to 60 years.

Detailed Description

Background: Plantar fasciitis (PF) is a common cause of heel pain, significantly impairing functionality and quality of life. Radial pressure wave therapy (RPWT) has emerged as a non-invasive therapeutic option. However, there is limited evidence regarding factors that may influence clinical outcomes in patients receiving this treatment.

Objectives: The primary objective of this study is to explore potential associations between baseline patient characteristics (such as age, body mass index, and pain intensity) and clinical outcomes in patients with PF treated with RPWT. Additionally, this study aims to assess changes in pain intensity and functionality following RPWT.

Materials and Methods: This is an exploratory, pilot observational study including patients diagnosed with PF who undergo three sessions of RPWT. The study evaluates changes in pain intensity, assessed using the Numerical Pain Rating Scale (NPRS), and functionality, measured using the WHODAS 2.0. Patient characteristics such as age, body mass index (BMI), and PF chronicity are collected retrospectively from medical records. Statistical analyses will be conducted to examine potential associations between patient characteristics and treatment outcomes.

Study Timeline

• Study Start: 2024-11-19
• Primary Completion: 2024-12-26
• Study Completion: 2025-01-20
• Study First Submitted: 2025-01-24
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-03
• Last Update Submitted: 2025-02-03
• Study First Posted: 2025-02-06
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Diagnosis of plantar fasciitis confirmed by clinical evaluation.
• Age 18 to 60 years.
• Symptoms persisting for at least three months before treatment.
• Completed three RPWT sessions using a standardized protocol (2000 impulses per session, 10 Hz, and 3.5 bar).
• Availability of complete medical records, including three-month follow-up data.

Exclusion Criteria

• History of foot surgery or corticosteroid injection in the affected limb within the past six months.
• Pregnancy at the time of treatment.
• Presence of concurrent musculoskeletal conditions (e.g., fractures, active infections, sprains) in the affected limb.
• Diagnosis of systemic conditions (e.g., cancer, osteoporosis, autoimmune diseases).
• Incomplete medical records or failure to complete RPWT sessions and follow-up visits.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain intensity assessed by the Numerical Pain Rating Scale (NPRS).	Immediately after the last RPWT session, approximately 1 week after baseline.	Pain intensity will be measured using the Numerical Pain Rating Scale (NPRS), a validated 10-point scale where 0 represents "no pain" and 10 represents "the worst pain imaginable."

Secondary Outcome Measures

Name	Time	Method
Functionality assessed by the WHODAS 2.0 scale.	Immediately after the last RPWT session, approximately 1 week after baseline.	Functionality will be evaluated using the WHODAS 2.0, a 12-item questionnaire assessing six domains of disability (cognition, mobility, self-care, interpersonal relationships, life activities, and community participation). Each item is rated on a 5-point scale, where higher scores indicate greater disability.

Trial Locations

Locations (1)

Hospital Civil de Guadalajara Fray Antonio Alcalde; 🇲🇽 Guadalajara, Jalisco, Mexico