臨床研究等提出・公開システム

Japanese

Date of registration	Sept. 01, 2020
Last modified on	Dec. 30, 2023
Trial ID	jRCTs032200082

Scientific Title	Clinical study on therapeutic effect of extracorporeal shockwave therapy for meniscal degenerative tear
Public Title	Therapeutic effect of extracorporeal shockwave therapy for meniscal degenerative tear

Completion date	Nov. 01, 2022
Result actual enrolment	29
Baseline Characteristics	There were 17 males and 12 females with a mean age of 63.8 years. Performance status was PS1 in all patients. All had degenerative tears of the medial meniscus on MRI. Mink classification of meniscus injury was Grade II in 4 patients, Grade IIIA in 11 patients, and Grade IIIB in 14 patients. The Kellgren-Lawrence classification of knee osteoarthritis was Grade 0 in 8 patients, Grade I in 14 patients, and Grade II in 7 patients. The patients were randomized and classified into ESWT and Control groups, with 15 in the ESWT group and 14 in the Control group.
Participant flow	One patient with Kellgren-Lawrence classification III after initial ESWT treatment was discontinued from the study because he met the exclusion criteria. One patient who had no improvement in pain after 6 months of visits was referred to surgery, and one patient was withdrawn from the study. All others remained in the study until the end of the study period.
Adverse events	none
Outcome measures	Primary endpoints: In this study, we evaluated MRI T2mapping T2 values based on a report that T2 values are about 3 ms higher in Williams classification II-III (degenerative) menisci compared to Williams classification 0 (normal) menisci. Compared to pre-treatment, at 12 months, the Control group had 1.0 ms, while the ESWT group had -2.9 ms, a statistically significant decrease (p<0.001). Secondary endpoints: The NRS for pain during walking at 12 months was 0.9 in the Control group versus 0.1 in the ESWT group, which was statistically significantly lower (p=0.035). At 12 months, the NRS for pain on ascending and descending stairs was 1.9 in the control group versus 0.4 in the ESWT group, a statistically significant decrease (p<0.038). Other clinical outcomes were not statistically significantly different. In the Control group, one patient did not show any improvement in symptoms and was sent to surgery.
Brief summary	ESWT for degenerative meniscus tears improved imaging MRI T2 mapping T2 values at 1 year. Pain NRS in the ESWT group was significantly lower than in the control group, but the improvement in clinical outcomes was not significant.
Date of posting of results summaries	Dec. 31, 2023
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description	No
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs032200082

Contact for Scientific Queries	Name	Chikuda Hirotaka
	Affiliation	Department of Orthopaedic Surgery, Gunma University Graduate School of Medicine
	Address	3-39-22 Showa-machi, Maebashi, Gunma, Japan
	Telephone	+81-27-220-8269
	E-mail	Chikudah@gunma-u.ac.jp
Contact for Public Queries	Name	Hashimoto Shogo
	Affiliation	Department of Orthopaedic Surgery, Gunma University Graduate School of Medicine
	Address	3-39-22 Showa-machi, Maebashi, Gunma, Japan
	Telephone	+81-27-220-8269
	E-mail	m1620023@gunma-u.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		Sept. 01, 2020
Actual date of first enrollment		Sept. 08, 2020
Target sample size		30
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	single blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Patients over 40 years old 2) Patients diagnosed with meniscal degeneration by MRI 3) Patients with knee pain above NRS2 4) Patients with PS between 0 and 1 5) Outpatient 6) Patients obtained from consent documents
	Exclusion Criteria	1) Patients with knee osteoarthritis of G3 or higher according to the Kellgren-Lawrence classification 2) Patients diagnosed with cognitive decline at the physician's discretion 3) Patients with untreated blood coagulation disorders such as hemophilia or patients taking anticoagulants 4) Patients with thrombosis 5) Patients with malignant tumor 6) Pregnant woman 7) Patients who have received steroid treatment for 6 months or more, or within 6 weeks after steroid injection 8) Patients judged inappropriate by the doctor
	Age Minimum	40age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Meniscal degenerative tear
Intervention(s)		Extracorporeal shockwave therapy
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		T2 value in MRI
Secondary Outcome(s)		Patient background (Age, Sex, Height, Weight, Body mass index, Medical history, Comorbidities, Drinking history, Smoking history) ESWT conditins (Energy flow density, Freaquency, Total energy) NRS (Walking, going up and down stairs) Clinical score (KOOS, IKDC score, Lysholme score) Scientific findings (Ballottement of patella, Range of motion, Mcmurray test, Watson-Jones test, Lachman test, Posterior drawer test) Adverse event Daily use of oral analgesics Transition rate to surgery after starting treatment

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Gunma University Hospital Clinical Research Review Board
Address	3-39-15, Showa-machi, Maebashi, Gunma, Gunma
Telephone	+81-27-220-8740
E-Mail	irb-jimukk-ciru@ml.gunma-u.ac.jp
Approval Status	Approval
Date of approval	May. 20, 2020

Secondary ID(s)	なし
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Dec. 31, 2023	(this page)	Changes
3	Aug. 27, 2021	Detail	Changes
2	Sept. 08, 2020	Detail	Changes
1	Sept. 01, 2020	Detail

List of change history