UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052560 |
|---|---|
| Receipt number | R000059970 |
| Scientific Title | Cohort study on the effects of acupuncture and rehabilitation on chronic low back pain |
| Date of disclosure of the study information | 2023/10/23 |
| Last modified on | 2024/10/21 08:56:15 |
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Basic information
Public title
Cohort study on the effects of acupuncture and rehabilitation on chronic low back pain
Acronym
Cohort study on the effects of acupuncture and rehabilitation on chronic low back pain
Scientific Title
Cohort study on the effects of acupuncture and rehabilitation on chronic low back pain
Scientific Title:Acronym
Cohort study on the effects of acupuncture and rehabilitation on chronic low back pain
Region
| Japan |
Condition
Condition
chronic low back pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to examine the effects of acupuncture and rehabilitation on the symptoms and conditions of patients with chronic low back pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation period: First visit, 1 month later, 3 months later
Evaluation items: VAS, RDQ, PDAS, PCS, EQ-5D-5L, costs incurred due to lower back pain, labor and work limitations due to lower back pain
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who visited the Tsukuba University of Technology, Center for Integrative Medicine
Sufferers of lower back pain
Persons who have not received acupuncture treatment or rehabilitation for lower back pain for 6 months.
Key exclusion criteria
Those who have undergone lower back surgery within the past year
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | HIROSHI |
| Middle name | |
| Last name | Kondo |
Organization
Tsukuba University of Technology
Division name
Faculty of Health Sciences
Zip code
305-8521
Address
4-12-7 Kasuga, Tsukuba-shi, Ibaraki-ken
TEL
049-858-9559
kondo0207@k.tsukuba-tech.ac.jp
Public contact
Name of contact person
| 1st name | HIROSHI |
| Middle name | |
| Last name | Kondo |
Organization
Tsukuba University of Technology
Division name
Faculty of Health Sciences
Zip code
305-8521
Address
4-12-7 Kasuga, Tsukuba-shi, Ibaraki-ken
TEL
049-858-9559
Homepage URL
kondo0207@k.tsukuba-tech.ac.jp
Sponsor or person
Institute
Tsukuba University of Technology
Institute
Department
Personal name
Funding Source
Organization
Tsukuba University of Technology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukuba University of Technology
Address
4-12-7 Kasuga, Tsukuba-shi, Ibaraki-ken
Tel
049-858-9559
kondo0207@k.tsukuba-tech.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
| 2023 | Year | 10 | Month | 23 | 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
Completed
Date of protocol fixation
| 2023 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is an observational study.Acupuncture and rehabilitation will be administered to research subjects. Evaluations will be conducted before the start of the treatment, one month after the start of the treatment, and three months after the start of the treatment to examine the effectiveness of each treatment and the characteristics of patients who are most effective.
Evaluation items include VAS, RDQ, PDAS, PCS, EQ-5D-5L, costs used for lower back pain, and labor and work limitations due to lower back pain.
Management information
Registered date
| 2023 | Year | 10 | Month | 20 | Day |
Last modified on
| 2024 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059970
