Effect of Extracorporeal Shock Wave in the Treatment of Knee Osteoarthritis

Sponsor

Peking University Third Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03962270

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis Cartilage Injury	Device: shock wave device	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of Extracorporeal Shock Wave in the Treatment of Knee Osteoarthritis

Actual Study Start Date :

Aug 1, 2018

Anticipated Primary Completion Date :

Aug 1, 2019

Anticipated Study Completion Date :

Aug 1, 2019

Arms and Interventions

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)

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

Outcome Measures

Primary Outcome Measures

magnetic resonance imaging of knee [Baseline (before treatment)]
t2 mapping
magnetic resonance imaging of knee [Three months after treatment]
t2 mapping

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Univercity Third Hospital	Beijing	No State Or Province	China	100191

Sponsors and Collaborators

Peking University Third Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mouwang Zhou, senior professional post, Peking University Third Hospital

ClinicalTrials.gov Identifier:

NCT03962270

Other Study ID Numbers:

M2018089

First Posted:

May 24, 2019

Last Update Posted:

May 24, 2019

Last Verified:

May 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mouwang Zhou, senior professional post, Peking University Third Hospital

Extracorporeal Shock Wave Therapy

Knee Osteoarthritis

Cartilage Injury

Additional relevant MeSH terms:

Osteoarthritis

Osteoarthritis, Knee

Study Results

No Results Posted as of May 24, 2019