Effect of Extracorporeal Shock Wave in the Treatment of Knee Osteoarthritis
1 other identifier
interventional
36
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable knee-osteoarthritis
Started Aug 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2018
CompletedFirst Submitted
Initial submission to the registry
October 30, 2018
CompletedFirst Posted
Study publicly available on registry
May 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedMay 24, 2019
May 1, 2019
1 year
October 30, 2018
May 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
magnetic resonance imaging of knee
t2 mapping
Baseline (before treatment)
magnetic resonance imaging of knee
t2 mapping
Three months after treatment
Study Arms (2)
Treatment group
EXPERIMENTALControl group
SHAM COMPARATORInterventions
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Univercity Third Hospital
Beijing, No State Or Province, 100191, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- senior professional post
Study Record Dates
First Submitted
October 30, 2018
First Posted
May 24, 2019
Study Start
August 1, 2018
Primary Completion
August 1, 2019
Study Completion
August 1, 2019
Last Updated
May 24, 2019
Record last verified: 2019-05