UMIN-CTR Clinical Trial

Public title

Study on prediction of knee pain relief by pain education and exercise

Acronym

Study for prediction of knee pain relief

Scientific Title

The effects and indications of a phased intervention strategy for knee pain

Scientific Title:Acronym

Study for prediction of knee pain relief

Region

Japan

Condition

knee pain

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to investigate the effects of pain education, gait modification, and aerobic exercise on knee pain relief in middle-aged people and to explore the characteristics of middle-aged people who do not achieve knee pain relief.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Knee pain

Time of evaluation: Before intervention (baseline), 5 weeks, 7 weeks, and after intervention start

Key secondary outcomes

1. Background: sex, age, height, weight, symptoms (stiffness, crepitus, bone tenderness, swelling), complications, medical history, current medical history, medication status
2. Gait function
3. Knee joint function
4. Muscle and fat mass
5. Physical activity
6. Pain Catastrophizing
7. Fear-avoidance beliefs

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Pain education (once a week, 4 weeks), gait modification (once a week, 2 weeks), and walking exercise (twice a week, 6 weeks)

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

50

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Those with knee pain (NRS >= 2)
2. Those who has been examined by a physician, has no rheumatoid arthritis, gout, osteonecrosis of the granular femur, patellar dislocation, or any other disease that requires emergency surgery and is not prohibited from exercising.
3. Those whose written consent to participate in the study is obtained from the individual.
4. Over 50 years old
5. No limitation for gender

Key exclusion criteria

1. After knee replacement surgery
2. Those suspected of serious cognitive impairment (19 points or less on Hasegawa's simple intelligence scale)
3. Those who has received exercise therapy at a medical institution in the past but is still in severe pain (NRS score of 8 or more), has limited range of motion (-5 degree or less in extension and 125 degree or less in flexion), and is unable to walk outdoors without a cane
4. Those who are prohibited from exercising by a doctor
5. Those who were unable to obtain permission from their physicians to participate in the study
6. Those who have started exercise therapy in a medical institution within 150 days

Target sample size

80

Name of lead principal investigator

1st name	Ryo
Middle name
Last name	Tanaka

Organization

Hiroshima University

Division name

Graduate School of Humanities and Social Sciences

Zip code

739-8521

Address

1-7-1 Kagamiyama, Higashi-Hiroshima City Hiroshima, Japan

TEL

082-454-6585

Email

ryotana@hiroshima-u.ac.jp

Name of contact person

1st name	Ryo
Middle name
Last name	Tanaka

Organization

Hiroshima University

Division name

Graduate School of Humanities and Social Sciences

Zip code

739-8521

Address

1-7-1 Kagamiyama, Higashi-Hiroshima City Hiroshima, Japan

TEL

082-454-6585

Homepage URL

Email

ryotana@hiroshima-u.ac.jp

Institute

Hiroshima University

Institute

Department

Personal name

Organization

The Nakatomi Fundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Center for Integrated Medical Research, Hiroshima University Hospital

Address

Minami-ku Kasumi 1-2-3, Hiroshima, Hiroshima, Japan

Tel

082-257-1551

Email

kasumi-kenkyu@office.hiroshima-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

06

Month

05

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

No longer recruiting

Date of protocol fixation

2020

Year

06

Month

04

Day

Date of IRB

2020

Year

06

Month

04

Day

Anticipated trial start date

2020

Year

06

Month

05

Day

Last follow-up date

2024

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

06

Month

05

Day

Last modified on

2024

Year

01

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044957