Knee OsteoarthritisNCT03962270
Effect of Extracorporeal Shock Wave in the Treatment of Knee Osteoarthritis
A study testing shock wave device in people with Knee Osteoarthritis and Cartilage Injury, run by Peking University Third Hospital at 1 site in China.
Trial summary
In this study, the effectiveness of ESWT in the treatment of knee OA was investigated from the perspective of cartilage injury，and to prove that shockwave could delay the early and middle stage OA progression by improving cartilage condition Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Knee Osteoarthritis, Cartilage Injury
- What is being tested?
- shock wave device
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2018to 1 Aug 2019
- Phase
- Interventional
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Knee joint ROM normal or near normal: flexion 110 ° or reach 0 ° or less
- MR prompt exist cartilage damage, there is no lack of full-thickness cartilage
- Kellgren - Lawrence (K - L) grade II - III grade
- The international association of cartilage repair cartilage damage grading system (ICRS) class I - III
- Informed consent and sign relevant documents
- Follow doctor's instructions and follow up on time
Who cannot join
- Metabolic arthritis
- Trauma of bone joint
- Inflammatory diseases
- Previous knee surgery history
- History of knee cavity injection in the past 6 months
- Serious cardiovascular diseases, pulmonary diseases or other serious diseases affecting survival, etc
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Univercity Third Hospital
Beijing, No State Or Province, 100191
Mingzhen Li, bachelor
About this study
In this study, the effectiveness of ESWT in the treatment of knee OA was investigated from the perspective of cartilage injury，and to prove that shockwave could delay the early and middle stage OA progression by improving cartilage condition
- Conditions
- Knee Osteoarthritis, Cartilage Injury
- Being tested
- shock wave device
- Keywords
- Extracorporeal Shock Wave Therapy, Knee Osteoarthritis, Cartilage Injury
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shock wave deviceDevice
The experimental group (group ESWT) guided by ultrasound: conventional rehabilitation training is given priority to with strength training, application of pain when necessary, under the guidance of ultrasound ESWT treatment control group (routine rehabilitation group) : conventional rehabilitation training is given priority to with strength training, oral pain when necessary, under the guidance of ultrasound ESWT treatment (shock energy flow density of 0)
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Not described Receives: Device: shock wave device |
| Control group | Sham comparator | Not described Receives: Device: shock wave device |
What is being measured
The primary outcome is the main question the study is designed to answer.
magnetic resonance imaging of knee
t2 mapping
Measured: Baseline (before treatment)
magnetic resonance imaging of knee
t2 mapping
Measured: Three months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start1 Aug 2018
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mouwang Zhou, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962270
- Sponsor's protocol ID
- M2018089
- Status last verified
- May 2019
- First submitted
- 30 Oct 2018
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Extracorporeal Shock Wave in the Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03962270
- Acronym / sponsor ID
- M2018089
- Conditions
- Knee Osteoarthritis, Cartilage Injury
- Keywords
- Extracorporeal Shock Wave Therapy, Knee Osteoarthritis, Cartilage Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 24 May 2019 (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.
In this study, the effectiveness of ESWT in the treatment of knee OA was investigated from the perspective of cartilage injury，and to prove that shockwave could delay the early and middle stage OA progression by improving cartilage condition
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: shock wave device |
| Control group | Sham comparator | Device: shock wave device |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Knee joint ROM normal or near normal: flexion 110 ° or reach 0 ° or less
- MR prompt exist cartilage damage, there is no lack of full-thickness cartilage
- Kellgren - Lawrence (K - L) grade II - III grade
- The international association of cartilage repair cartilage damage grading system (ICRS) class I - III
- Informed consent and sign relevant documents
Key exclusion criteria (6 listed)
- Metabolic arthritis
- Trauma of bone joint
- Inflammatory diseases
- Previous knee surgery history
- History of knee cavity injection in the past 6 months
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 |
|---|---|---|
| shock wave deviceThe experimental group (group ESWT) guided by ultrasound: conventional rehabilitation training is given priority to with strength training, application of pain when necessary, under the guidance of ultrasound ESWT treatment control group (routine rehabilitation group) : conventional rehabilitation training is given priority to with strength training, oral pain when necessary, under the guidance of ultrasound ESWT treatment (shock energy flow density of 0) | Device | Control group, Treatment group |
Primary outcome
magnetic resonance imaging of knee
Time frame: Baseline (before treatment)
t2 mapping
magnetic resonance imaging of knee
Time frame: Three months after treatment
t2 mapping
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing shock wave device in people with Knee Osteoarthritis and Cartilage Injury, run by Peking University Third Hospital at 1 site in China.
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 6 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: status not confirmed, as of the sponsor's last update on 24 May 2019. 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 China. 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.
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?
Contact mouwang 谋望 zhou, master (13910092892 ext. 周, zhoumouwang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
magnetic resonance imaging of knee (time frame: Baseline (before treatment)). The study lists 2 primary outcomes in all. 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 24 May 2019.