Outcome 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.

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Key information

Conditions

Fasciitis, Plantar Fasciitis Fasciitis, Plantar, Chronic Foot Diseases Musculoskeletal Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Jalisco, 44280, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

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."

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Hospital Civil de Guadalajara

Other

Collaborators

University of Guadalajara

Registry information

Official study title

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

Acronym: RPWT

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2025
First posted: Feb 6, 2025
Registry last updated: Feb 6, 2025

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.

Published trials that share one or more normalized conditions with this study.

Completed