Outcome After Radial Pressure Wave Therapy in Plantar Fasciitis. (RPWT)

February 3, 2025 updated by: Armando Tonatiuh Avila Garcia, Hospital Civil de Guadalajara

Exploratory Analysis of Pain and Function Improvement After Radial Pressure Wave Therapy in Plantar Fasciitis.

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Mexico
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44280
    - Hospital Civil de Guadalajara Fray Antonio Alcalde

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

This study focuses on adult patients diagnosed with plantar fasciitis (PF), a condition commonly affecting middle-aged individuals. Eligible participants are between 18 and 60 years old and present with symptoms persisting for at least three months before treatment. Given that risk factors such as body mass index (BMI) and physical activity levels may influence clinical outcomes, these characteristics will be documented for all participants. Additionally, data on prior conventional physical therapy and PF chronicity (acute vs. chronic cases) will be collected to explore potential associations with treatment response.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity assessed by the Numerical Pain Rating Scale (NPRS). Time Frame: 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."	Immediately after the last RPWT session, approximately 1 week after baseline.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functionality assessed by the WHODAS 2.0 scale. Time Frame: 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.	Immediately after the last RPWT session, approximately 1 week after baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Civil de Guadalajara

Collaborators

University of Guadalajara

Investigators

Principal Investigator: Armando Tonatiuh Avila Garcia, MD, Hospital Civil de Guadalajara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2024

Primary Completion (Actual)

December 26, 2024

Study Completion (Actual)

January 20, 2025

Study Registration Dates

First Submitted

January 24, 2025

First Submitted That Met QC Criteria

February 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)