search
Back to results

Effect of Extracorporeal Shock Wave in the Treatment of Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis, Cartilage Injury

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
shock wave device
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Extracorporeal Shock Wave Therapy, Knee Osteoarthritis, Cartilage Injury

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Peking Univercity Third HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment group

Control group

Arm Description

Outcomes

Primary Outcome Measures

magnetic resonance imaging of knee
t2 mapping
magnetic resonance imaging of knee
t2 mapping

Secondary Outcome Measures

Full Information

First Posted
October 30, 2018
Last Updated
May 23, 2019
Sponsor
Peking University Third Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03962270
Brief Title
Effect of Extracorporeal Shock Wave in the Treatment of Knee Osteoarthritis
Official Title
Effect of Extracorporeal Shock Wave in the Treatment of Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
August 1, 2019 (Anticipated)
Study Completion Date
August 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Third Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Cartilage Injury
Keywords
Extracorporeal Shock Wave Therapy, Knee Osteoarthritis, Cartilage Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
shock wave device
Intervention Description
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)
Primary Outcome Measure Information:
Title
magnetic resonance imaging of knee
Description
t2 mapping
Time Frame
Baseline (before treatment)
Title
magnetic resonance imaging of knee
Description
t2 mapping
Time Frame
Three months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mouwang 谋望 zhou, master
Phone
13910092892
Ext
周
Email
zhoumouwang@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
mingzhen 明真 Lee, bachelor
Phone
18810334425
Ext
李
Email
mingzhenli@126.com
Facility Information:
Facility Name
Peking Univercity Third Hospital
City
Beijing
State/Province
No State Or Province
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingzhen Li, bachelor

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Effect of Extracorporeal Shock Wave in the Treatment of Knee Osteoarthritis

We'll reach out to this number within 24 hrs