Osteoarthritis, KneePRE-RPWT-OANCT07531160
Baseline Predictors of Response to Radial Pressure Wave Therapy in Knee Osteoarthritis
An observational study of Osteoarthritis, Knee and Knee Osteoarthritis, run by Hospital Civil de Guadalajara at 1 site in Mexico.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Knee Osteoarthritis
- What is being tested?
- Radial Pressure Wave Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 62 participants
- Where
- 1 siteMexico
- Study dates
- 19 Nov 2024to 20 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, 44280
About this study
Official 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.
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee, Knee Osteoarthritis
- Being tested
- Radial Pressure Wave Therapy
- Keywords
- Radial Pressure Wave Therapy, rESWT, Shockwave Therapy, Knee Osteoarthritis, Predictors, Clinical Response, Prognostic Factors
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial Pressure Wave TherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Radial Pressure Wave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 6 months after baseline
Change in WOMAC score over time
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.
Measured: Baseline, 2 months, 4 months, and 6 months
Change in pain intensity measured by the Numerical Pain Rating Scale (NPRS) over time
Change in pain intensity from baseline measured using the Numerical Pain Rating Scale (NPRS) at different follow-up time points.
Measured: Baseline, 2 months, 4 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start19 Nov 2024
- Primary completion26 Dec 2024
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Civil de Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Armando Tonatiuh Avila Garcia, Hospital Civil de Guadalajara
- Investigators
- Armando Tonatiuh Avila Garcia, MD, Principal investigator, Hospital Civil de Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07531160
- Sponsor's protocol ID
- CEI 246/25
- Acronym
- PRE-RPWT-OA
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34038642Charles 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.
PubMed 37662911Li 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.
PubMed 31435724Vahdatpour 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.
PubMed 23826009
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07531160
- Acronym / sponsor ID
- PRE-RPWT-OA / CEI 246/25
- Conditions
- Osteoarthritis, Knee, Knee Osteoarthritis
- Keywords
- Radial Pressure Wave Therapy, rESWT, Shockwave Therapy, Knee Osteoarthritis, Predictors, Clinical Response, Prognostic Factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Hospital Civil de GuadalajaraUniversity, hospital or other
- Study start
- 19 Nov 2024 (actual)
- Primary completion
- 26 Dec 2024 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with knee osteoarthritis treated with radial pressure wave therapy | – | Procedure: Radial Pressure Wave TherapyAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radial Pressure Wave TherapyRadial 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. | Procedure or surgery | Patients with knee osteoarthritis treated with radial pressure wave therapy |
Primary outcome
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.
3 secondary outcomes
Achievement of minimal clinically important difference (MCID) in pain intensity measured by the Numerical Pain Rating Scale (NPRS)
Time frame: 6 months after baseline
Change in WOMAC score over time
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Results publication: PubMed 34038642Melese 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.
- Results publication: PubMed 37662911Charles 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.
- Results publication: PubMed 31435724Li 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.
- Results publication: PubMed 23826009Vahdatpour 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armando Tonatiuh Avila Garcia, MD principal investigator
Hospital Civil de Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee and Knee Osteoarthritis, run by Hospital Civil de Guadalajara at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of minimal clinically important difference (MCID) in pain intensity measured by the Numerical Pain Rating Scale (NPRS) (time frame: 6 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07531160, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.