Baseline Predictors of Response to Radial Pressure Wave Therapy in Knee Osteoarthritis (PRE-RPWT-OA)

April 9, 2026 updated by: Armando Tonatiuh Avila Garcia, Hospital Civil de Guadalajara

Baseline Predictors of Six-Month Clinical Response to Radial Pressure Wave Therapy in Patients With Knee Osteoarthritis: Secondary Analysis of a Randomized Double-Blind Clinical Trial.

This observational study aims to identify baseline factors that predict clinical response at six months in patients with knee osteoarthritis treated with radial pressure wave therapy (rESWT). The study is a secondary analysis of data obtained from a randomized double-blind clinical trial conducted in 2024 at a tertiary care hospital in Mexico.

Knee osteoarthritis is a common condition that causes pain, stiffness, and reduced physical function. Radial pressure wave therapy is a non-invasive treatment that has shown benefits in improving symptoms; however, not all patients respond equally.

This study will analyze patient characteristics at baseline, such as age, body mass index, pain severity, and functional status, to determine which factors are associated with meaningful improvement in pain and function after treatment. The results may help clinicians better identify which patients are more likely to benefit from this therapy and improve personalized treatment decisions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Knee osteoarthritis (OA) is a leading cause of pain and disability worldwide. It is characterized by progressive joint degeneration, resulting in pain, stiffness, and functional limitations. Radial pressure wave therapy (rESWT) is a non-invasive treatment that has demonstrated effectiveness in reducing pain and improving function in patients with knee OA. However, there is significant variability in patient response, and the factors that predict treatment success are not well established.

Objective: The aim of this study is to identify baseline predictors of clinical response at six months in patients with knee OA treated with rESWT.

Methods: This study is a secondary analysis of a randomized double-blind clinical trial conducted in 2024 at the Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde". The original trial evaluated the effectiveness of three standardized rESWT protocols in patients with knee OA. The present study is designed as an observational cohort analysis including patients with complete baseline and follow-up data.

Baseline variables include demographic characteristics (age, sex), clinical factors (body mass index, baseline pain intensity, functional status), and radiographic severity. The primary outcome is the achievement of the minimal clinically important difference (MCID) in the WOMAC score at six months. Secondary outcomes include MCID in pain intensity measured by the Numerical Pain Rating Scale (NPRS) and changes in WOMAC and NPRS scores over time.

Statistical analyses will be conducted to identify independent predictors of clinical response and to explore the interaction between baseline characteristics and treatment protocols.

Significance: Identifying predictors of response to rESWT may improve patient selection, optimize treatment strategies, and contribute to more personalized and cost-effective care in patients with knee osteoarthritis.

Study Type

Observational

Enrollment (Actual)

62

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
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with clinically and radiographically confirmed knee osteoarthritis who participated in a randomized double-blind clinical trial evaluating radial pressure wave therapy (rESWT) at a tertiary care hospital in Mexico in 2024. Only participants with complete baseline and six-month follow-up data are included in this secondary analysis.

Description

Inclusion Criteria:

  • Clinical and radiographic diagnosis of knee osteoarthritis
  • Participation in the original randomized double-blind clinical trial evaluating radial pressure wave therapy (rESWT) in 2024
  • Availability of complete baseline data
  • Availability of follow-up data up to 6 months

Exclusion Criteria:

  • Incomplete baseline or follow-up data
  • Withdrawal from the original trial before completion
  • Missing outcome measurements required for analysis
  • Presence of conditions that could interfere with outcome assessment or data validity

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with knee osteoarthritis treated with radial pressure wave therapy
Adult patients with clinically and radiographically diagnosed knee osteoarthritis who participated in a randomized double-blind clinical trial evaluating radial pressure wave therapy (rESWT) in 2024. This cohort includes participants with complete baseline and follow-up data up to six months and is used to identify baseline predictors of clinical response.
Procedure: Radial Pressure Wave Therapy
Radial pressure wave therapy (rESWT) administered according to standardized protocols in the original randomized clinical trial. The therapy involves the application of acoustic waves to the knee joint to reduce pain and improve function.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Achievement of minimal clinically important difference (MCID) in pain intensity measured by the Numerical Pain Rating Scale (NPRS)
Time Frame: 6 months after baseline
The proportion of patients achieving the minimal clinically important difference (MCID) in pain intensity measured using the Numerical Pain Rating Scale (NPRS), a validated 0 to 10 scale where higher scores indicate greater pain.
6 months after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Achievement of minimal clinically important difference (MCID) in pain intensity measured by the Numerical Pain Rating Scale (NPRS)
Time Frame: 6 months after baseline
The proportion of patients achieving the minimal clinically important difference (MCID) in pain intensity measured using the Numerical Pain Rating Scale (NPRS), a validated 0 to 10 scale where higher scores indicate greater pain.
6 months after baseline
Change in WOMAC score over time
Time Frame: Baseline, 2 months, 4 months, and 6 months
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score from baseline across follow-up assessments, reflecting changes in pain, stiffness, and physical function.
Baseline, 2 months, 4 months, and 6 months
Change in pain intensity measured by the Numerical Pain Rating Scale (NPRS) over time
Time Frame: Baseline, 2 months, 4 months, and 6 months
Change in pain intensity from baseline measured using the Numerical Pain Rating Scale (NPRS) at different follow-up time points.
Baseline, 2 months, 4 months, and 6 months

Collaborators and Investigators

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

Sponsor

Hospital Civil de 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

April 9, 2026

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEI 246/25

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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