UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044827 |
|---|---|
| Receipt number | R000051202 |
| Scientific Title | Effects of a physical activity program with pain education on health-related quality of life in older adults with pain after lumbar spinal stenosis surgery |
| Date of disclosure of the study information | 2021/07/12 |
| Last modified on | 2024/01/11 10:11:14 |
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Basic information
Public title
Effects of an exercise program with pain education on subjective health in older adults after lumbar spine surgery.
Acronym
Effectiveness of exercise program with pain education
Scientific Title
Effects of a physical activity program with pain education on health-related quality of life in older adults with pain after lumbar spinal stenosis surgery
Scientific Title:Acronym
Effects of a physical activity program with pain education on health-related quality of life
Region
| Japan |
Condition
Condition
Lumbar spinal stenosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the effectiveness of pain education and programs to increase physical activity for older adults with chronic pain after lumbar spinal stenosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Health-related quality of life at three months after starting the program
Key secondary outcomes
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
Gradual increase in the amount of physical activity over a 3-month period
Interventions/Control_2
Non-intervention for 3 months
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have undergone spinal canal decompression surgery (with or without fusion surgery) for lumbar spinal stenosis
Key exclusion criteria
Patients who have not received permission from their physician to participate in the study
Patients who have severe pain (8 points or more on a 10-point numerical rating scale) and require physical assistance in daily life
Patients who could not fully understand the research due to cognitive decline
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Higuchi |
Organization
Takasaki University of Health and Welfare
Division name
Department of Physical Therapy
Zip code
370-0033
Address
501 Nakaorui-machi, Takasaki-shi, Gunma
TEL
027-352-1291
higuchi-d@takasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Higuchi |
Organization
Takasaki University of Health and Welfare
Division name
Department of Physical Therapy
Zip code
370-0033
Address
501 Nakaorui-machi, Takasaki-shi, Gunma
TEL
027-352-1291
Homepage URL
higuchi-d@takasaki-u.ac.jp
Sponsor or person
Institute
Takasaki University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Takasaki University of Health and Welfare Research Ethics Committee
Address
37-1 Nakaorui-machi, Takasaki-shi, Gunma
Tel
027-352-1290
mune@takasaki-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
| 2021 | Year | 07 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2021 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | 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
| 2021 | Year | 07 | Month | 11 | Day |
Last modified on
| 2024 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051202
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
