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NCT Number: NCT07531160

Baseline Predictors of Response to Radial Pressure Wave Therapy in Knee Osteoarthritis

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Knee Osteoarthritis Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Jalisco, 44280, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Radial Pressure Wave Therapy

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Hospital Civil de Guadalajara

Other

Registry information

Official study title

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.

Acronym: PRE-RPWT-OA

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 15, 2026
Registry last updated
Apr 15, 2026

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.

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