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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040667
Receipt No. R000044957
Scientific Title The effects and indications of a phased intervention strategy for knee pain
Date of disclosure of the study information 2020/06/05
Last modified on 2020/06/05

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Basic information
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
Condition knee pain
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Hiroshima University
Institute
Department

Funding Source
Organization The Nakatomi Fundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
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
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
2020 Year 06 Month 05 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
Recruitment status Open public 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
2023 Year 03 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
2020 Year 06 Month 05 Day
Last modified on
2020 Year 06 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044957

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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