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

NCT07531160 | Completed

• 1 other identifier: CEI 246/25
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis, Knee; Knee Osteoarthritis

Keywords

Radial Pressure Wave Therapy; rESWT; Shockwave Therapy; Knee Osteoarthritis; Predictors; Clinical Response; Prognostic Factors

Outcome Measures

Primary Outcomes (1)

• Achievement of minimal clinically important difference (MCID) in pain intensity measured by the Numerical Pain Rating Scale (NPRS)

  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 Outcomes (3)

• Achievement of minimal clinically important difference (MCID) in pain intensity measured by the Numerical Pain Rating Scale (NPRS)

  6 months after baseline

• Change in WOMAC score over time

  Baseline, 2 months, 4 months, and 6 months

• Change in pain intensity measured by the Numerical Pain Rating Scale (NPRS) over time

  Baseline, 2 months, 4 months, and 6 months

Study Arms (1)

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

Interventions

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.

Patients with knee osteoarthritis treated with radial pressure wave therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Civil de Guadalajara: lead

Study Sites (1)

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Jalisco, 44280, Mexico

Location

Related Publications (4)

• Melese H, Alamer A, Getie K, Nigussie F, Ayhualem S. Extracorporeal shock wave therapy on pain and foot functions in subjects with chronic plantar fasciitis: systematic review of randomized controlled trials. Disabil Rehabil. 2022 Sep;44(18):5007-5014. doi: 10.1080/09638288.2021.1928775. Epub 2021 May 26.

  PMID: 34038642 RESULT

• Charles R, Fang L, Zhu R, Wang J. The effectiveness of shockwave therapy on patellar tendinopathy, Achilles tendinopathy, and plantar fasciitis: a systematic review and meta-analysis. Front Immunol. 2023 Aug 16;14:1193835. doi: 10.3389/fimmu.2023.1193835. eCollection 2023.

  PMID: 37662911 RESULT

• Li H, Xiong Y, Zhou W, Liu Y, Liu J, Xue H, Hu L, Panayi AC, Mi B, Liu G. Shock-wave therapy improved outcome with plantar fasciitis: a meta-analysis of randomized controlled trials. Arch Orthop Trauma Surg. 2019 Dec;139(12):1763-1770. doi: 10.1007/s00402-019-03262-z. Epub 2019 Aug 21.

  PMID: 31435724 RESULT

• Vahdatpour B, Sajadieh S, Bateni V, Karami M, Sajjadieh H. Extracorporeal shock wave therapy in patients with plantar fasciitis. A randomized, placebo-controlled trial with ultrasonographic and subjective outcome assessments. J Res Med Sci. 2012 Sep;17(9):834-8.

  PMID: 23826009 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Armando Tonatiuh Avila Garcia, MD

  Hospital Civil de Guadalajara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Department of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 15, 2026
• Study Start: November 19, 2024
• Primary Completion: December 26, 2024
• Study Completion: January 20, 2025
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

ME (1)