Effect of Extracorporeal Shock Wave in the Treatment of Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Effect of Extracorporeal Shock Wave in the Treatment of Knee Osteoarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03962270
• Other study ID #: M2018089
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: May 2019
• Source: Peking University Third Hospital
• Contact: mouwang ?? zhou, master
• Phone: 13910092892
• Email: zhoumouwang[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cartilage Injury
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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)

Locations

Country	Name	City	State
China	Peking Univercity Third Hospital	Beijing	No State Or Province

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	magnetic resonance imaging of knee	t2 mapping	Baseline (before treatment)
Primary	magnetic resonance imaging of knee	t2 mapping	Three months after treatment