Osteoarthritis, KneePhase 2NCT03344770
The Efficacy of Radial Extracorporeal Shockwave Therapy on Knee Osteoarthritis
A Phase 2 study testing Active rESWT in people with Osteoarthritis, Knee, run by Marta Imamura at 1 site in Brazil.
Trial summary
This is a double-blind placebo controlled trial whose objective is to understand how much the radial extracorporeal shockwave therapy can improve function of patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Active rESWT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Oct 2017to Oct 2025
- Phase
- Phase 2
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of knee osteoarthritis;
- Onset knee pain with moderate or severe intensity: Visual Analogue Scale (VAS) > 4;
- Onset knee pain over 3 months prior to the inclusion;
Who cannot join
- Presence of psychiatric disease;
- Presence of fibromyalgia;
- Presence of systemic inflammatory rheumatic diseases;
- History of neoplasia;
- Presence of clinical diseases in other joints;
- Ongoing use of anticoagulant drugs.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Medicina Fisica e Reabilitacao HCFMUSP
São Paulo, 05716-150
About this study
Official title: The Efficacy of Radial Extracorporeal Shockwave Therapy (RESWT) for Functional Improvement of Patients With Knee Osteoarthritis - A Double-blind Randomized Trial
This is a double-blind placebo controlled trial whose objective is to understand how much the radial extracorporeal shockwave therapy can improve function of patients with knee osteoarthritis.
For this trial, patients with knee osteoarthritis, after signing the informed consent form and having their demographic and baseline information collected, will be randomly allocated into one of both treatment arms: radial extracorporeal shockwave therapy (rESWT) or sham radial extracorporeal shockwave therapy. Then, they will undertake three sessions of rESWT, for three weeks, i.e. one session per week.
Read more
Patients will be assessed prior to the therapy, one week after the end of the therapy and three months after the end of the therapy, and the primary outcome of this study is the functional change measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) validated in Portuguese, three months after the end of the therapy.
Secondary outcomes, will be the change of pain, the change of pressure pain tolerance threshold, change in diffuse noxious inhibitory control (DNIC), and thermographic changes.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Active rESWT, Sham rESWT
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active rESWTDevice
5,000 pulses of rESWT, with 0.16mJ/mm2 of energy at a frequency of 20Hz once a week for three weeks.
Sham rESWTDevice
5,000 pulses of rESWT, with 0.0 mJ/mm2 of energy at a frequency of 20Hz once a week for three weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active rESWT | Experimental | Application of 5,000 pulses of rESWT by a pneumatic generator, with 0.16mJ/mm2 (millijoule per squared millimeter) of energy at a frequency of 20Hz on the most painful spot of the knee. The applications will be given once a week for three weeks. Receives: Device: Active rESWT |
| Sham rESWT | Sham comparator | Application of 5,000 pulses of rESWT by a pneumatic generator, at a frequency of 20Hz on the most painful spot of the knee with 0 mJ/mm2 energy. The applications will also be given once a week for three weeks. Receives: Device: Sham rESWT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Change
Functional change from baseline, measured by KOOS.
Measured: At baseline and three months after the end of the treatment.
Secondary outcomes (5)
Short Term Functional Changes
Functional change from baseline, measured by KOOS
Measured: At baseline and one week after the end of the treatment.
Knee pain reduction
Knee pain changes from baseline, measured by KOOS
Measured: At baseline, one week and three months after the end of the treatment
Pain pressure threshold tolerance changes
Changes in pain pressure threshold tolerance over time, measured by algometer
Measured: At baseline, one week and three months after the end of the treatment
Diffuse noxious inhibitory control alterations
Changes in diffuse noxious inhibitory control over time, measured by algometer
Measured: At baseline, one week and three months after the end of the treatment
Thermography evaluation
Changes thermographic characteristics of lower limbs and knee over time, measured by Infrared Thermography
Measured: At baseline, one week and three months after the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start20 Oct 2017
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Why it stopped: Study suspended due to Covid-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marta Imamura
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marta Imamura, University of Sao Paulo
- Investigators
- Marta Imamura, MD, Principal investigator, Instituto de Medicina Física e Reabilitação HCFMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344770
- Sponsor's protocol ID
- 72067817.8.0000.0068
- Status last verified
- May 2024
- First submitted
- 13 Nov 2017
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Radial Extracorporeal Shockwave Therapy (RESWT) for Functional Improvement of Patients With Knee Osteoarthritis - A Double-blind Randomized Trial
- ClinicalTrials.gov ID
- NCT03344770
- Acronym / sponsor ID
- 72067817.8.0000.0068
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study suspended due to Covid-19 pandemic.
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Marta ImamuraUniversity, hospital or other
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 17 Nov 2017 (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 is a double-blind placebo controlled trial whose objective is to understand how much the radial extracorporeal shockwave therapy can improve function of patients with knee osteoarthritis.
For this trial, patients with knee osteoarthritis, after signing the informed consent form and having their demographic and baseline information collected, will be randomly allocated into one of both treatment arms: radial extracorporeal shockwave therapy (rESWT) or sham radial extracorporeal shockwave therapy. Then, they will undertake three sessions of rESWT, for three weeks, i.e. one session per week.
Patients will be assessed prior to the therapy, one week after the end of the therapy and three months after the end of the therapy, and the primary outcome of this study is the functional change measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) validated in Portuguese, three months after the end of the therapy.
Secondary outcomes, will be the change of pain, the change of pressure pain tolerance threshold, change in diffuse noxious inhibitory control (DNIC), and thermographic changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active rESWT | Experimental | Device: Active rESWTApplication of 5,000 pulses of rESWT by a pneumatic generator, with 0.16mJ/mm2 (millijoule per squared millimeter) of energy at a frequency of 20Hz on the most painful spot of the knee. The applications will be given once a week for three weeks. |
| Sham rESWT | Sham comparator | Device: Sham rESWTApplication of 5,000 pulses of rESWT by a pneumatic generator, at a frequency of 20Hz on the most painful spot of the knee with 0 mJ/mm2 energy. The applications will also be given once a week for three weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of knee osteoarthritis;
- Onset knee pain with moderate or severe intensity: Visual Analogue Scale (VAS) > 4;
- Onset knee pain over 3 months prior to the inclusion;
Key exclusion criteria (6 listed)
- Presence of psychiatric disease;
- Presence of fibromyalgia;
- Presence of systemic inflammatory rheumatic diseases;
- History of neoplasia;
- Presence of clinical diseases in other joints;
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 |
|---|---|---|
| Active rESWT5,000 pulses of rESWT, with 0.16mJ/mm2 of energy at a frequency of 20Hz once a week for three weeks. | Device | Active rESWT |
| Sham rESWT5,000 pulses of rESWT, with 0.0 mJ/mm2 of energy at a frequency of 20Hz once a week for three weeks. | Device | Sham rESWT |
Primary outcome
Functional Change
Time frame: At baseline and three months after the end of the treatment.
Functional change from baseline, measured by KOOS.
5 secondary outcomes
Short Term Functional Changes
Time frame: At baseline and one week after the end of the treatment.
Knee pain reduction
Time frame: At baseline, one week and three months after the end of the treatment
Pain pressure threshold tolerance changes
Time frame: At baseline, one week and three months after the end of the treatment
Diffuse noxious inhibitory control alterations
Time frame: At baseline, one week and three months after the end of the treatment
Thermography evaluation
Time frame: At baseline, one week and three months after the end of the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
Marta Imamura, MD principal investigator
Instituto de Medicina Física e Reabilitação HCFMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Active rESWT in people with Osteoarthritis, Knee, run by Marta Imamura at 1 site in Brazil.
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 3 inclusion and 6 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: paused, as of the sponsor's last update on 16 May 2024. 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 Brazil. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Functional Change (time frame: At baseline and three months after the end of the treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2024.