UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040667 |
|---|---|
| Receipt number | 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 | 2024/06/10 12:47:51 |
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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
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
ryotana@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
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
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
80
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
Completed
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
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 05 | Day |
Last modified on
| 2024 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044957
