UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035225
Receipt number R000036946
Scientific Title Effectiveness of Supervised Exercise Therapy for Community-dwelling People with Chronic Knee Pain:a randomised controlled trial.
Date of disclosure of the study information 2018/12/11
Last modified on 2022/12/17 17:10:27

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Basic information

Public title

Effectiveness of Supervised Exercise Therapy for Community-dwelling People with Chronic Knee Pain:a randomised controlled trial.

Acronym

Chronic Knee Pain & Supervised Exercise Therapy

Scientific Title

Effectiveness of Supervised Exercise Therapy for Community-dwelling People with Chronic Knee Pain:a randomised controlled trial.

Scientific Title:Acronym

Chronic Knee Pain & Supervised Exercise Therapy

Region

Japan


Condition

Condition

Chronic Knee Pain

Classification by specialty

Orthopedics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate effectiveness of supervised exercise therapy for community-dwelling people with chronic knee pain.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Knee injury and Osteoarthritis Outcome Score (KOOS)

Key secondary outcomes

Numerical Rating Scale(NRS); Self-Efficasy, Pain Self-Efficasy Questionnaire; QOL, EuroQol 5 Dimension


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Supervised exercise therapy for chronic knee pain with textbook use, intervention period: about 1 month

Interventions/Control_2

only textbook use and/or usual care

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

40 years-old <=

Age-upper limit

79 years-old >=

Gender

Male and Female

Key inclusion criteria

Participants of annual health check survey, who have reported chronic knee pain

Key exclusion criteria

Those suspected of pain by rheumatism etc.
Those planned for knee surgery or Those with knee surgery history
Thoese judged unsuitable for exercise by a doctor.
Those who have difficulty answering questionnaire.

Target sample size

44


Research contact person

Name of lead principal investigator

1st name Jinnouchi
Middle name
Last name Hiroshige

Organization

Nippon Medical School

Division name

Hygiene & Public Health

Zip code

113-8602

Address

1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8602, Japan

TEL

03-3822-2131

Email

h-jinnouchi@nms.ac.jp


Public contact

Name of contact person

1st name Jinnouchi
Middle name
Last name Hiroshige

Organization

Nippon Medical School

Division name

Hygiene and Public Health

Zip code

113-8602

Address

1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8602, Japan

TEL

03-3822-2131

Homepage URL


Email

h-jinnouchi@nms.ac.jp


Sponsor or person

Institute

Nippon Medical School

Institute

Department

Personal name



Funding Source

Organization

Fullhap

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor

Collaborating research institutes: Osaka Center for Cancer and Cardiovascular Disease Prevention/ Tokyo Metropolitan Institute of Gerontology. Cooperating Research Institute: Graduate School of Medicine, Osaka University/22nd Century Medical and Research Center, The University of Tokyo.

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Board of Nippon Medical School

Address

1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8602, Japan

Tel

03-3822-2131

Email

nms_rinri@nms.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2018 Year 12 Month 11 Day


Related information

URL releasing protocol

Unpublished

Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.1093/mr/roac009

Number of participants that the trial has enrolled

46

Results

Compared to material-based education alone, the brief-See provided significant additional improvements of 9.4% (95% CI: 2.3 to 16.4) on the KOOS4 and 5.4 points (0.3 to 10.4) on the PSEQ at 12 weeks but did not on the NRS and EQ-5D. Adherence and satisfaction were favourable in the brief-See without any notable adverse event.

Results date posted

2021 Year 06 Month 14 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Participants aged 40 to 79 years from systematic recruitment via an annual cardiovascular risk survey,

Participant flow

Forty-six participants with chronic knee pain were randomly allocated into two programmes: material-based education alone or brief self-exercise education (brief-See), which comprised a 100-minute instruction for self-exercise combined with compact pain education.

Adverse events

No notable adverse event.

Outcome measures

Total function (KOOS4, 4-subscale average of knee injury and osteoarthritis outcome score), pain intensity (NRS, numeric rating scale), self-efficacy (PSEQ, pain self-efficacy questionnaire), and health-related quality of life (EQ-5D, European quality of life-5 dimensions) were evaluated at baseline and 4 and 12 weeks after the initial intervention.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2018 Year 07 Month 30 Day

Date of IRB

2018 Year 04 Month 05 Day

Anticipated trial start date

2018 Year 07 Month 30 Day

Last follow-up date

2019 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 12 Month 11 Day

Last modified on

2022 Year 12 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036946


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name