Effect of Extracorporeal Shock Wave in the Treatment of Knee Osteoarthritis

NCT ID: NCT03962270

Last Updated: 2019-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2019-08-01

Brief Summary

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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

Detailed Description

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Conditions

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Knee Osteoarthritis Cartilage Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Treatment group

Group Type EXPERIMENTAL

shock wave device

Intervention Type 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)

Control group

Group Type SHAM_COMPARATOR

shock wave device

Intervention Type 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)

Interventions

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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)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mouwang Zhou

senior professional post

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peking Univercity Third Hospital

Beijing, No State Or Province, China

Site Status RECRUITING

Countries

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China

Central Contacts

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mouwang 谋望 zhou, master

Role: CONTACT

13910092892 ext. 周

mingzhen 明真 Lee, bachelor

Role: CONTACT

18810334425 ext. 李

Other Identifiers

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M2018089

Identifier Type: -

Identifier Source: org_study_id

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