Effect of Extracorporeal Shock Wave in the Treatment of Knee Osteoarthritis

May 23, 2019 updated by: Mouwang Zhou, Peking University Third Hospital
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • No State Or Province
      • Beijing, No State Or Province, China, 100191
        • Recruiting
        • Peking Univercity Third Hospital
        • Sub-Investigator:
          • Mingzhen Li, bachelor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
Device: shock wave device
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)
Sham Comparator: Control group
Device: shock wave device
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
magnetic resonance imaging of knee
Time Frame: Baseline (before treatment)
t2 mapping
Baseline (before treatment)
magnetic resonance imaging of knee
Time Frame: Three months after treatment
t2 mapping
Three months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Anticipated)

August 1, 2019

Study Completion (Anticipated)

August 1, 2019

Study Registration Dates

First Submitted

October 30, 2018

First Submitted That Met QC Criteria

May 23, 2019

First Posted (Actual)

May 24, 2019

Study Record Updates

Last Update Posted (Actual)

May 24, 2019

Last Update Submitted That Met QC Criteria

May 23, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M2018089

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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