UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044436 |
|---|---|
| Receipt number | R000050762 |
| Scientific Title | Pain Neuroscience Education for Patients With Chronic Low Back Pain. A Double-Blind Randomized Controlled Trial |
| Date of disclosure of the study information | 2021/06/04 |
| Last modified on | 2024/12/06 10:53:54 |
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Basic information
Public title
Effects of back school on physical and psychological functions of people with chronic low back pain
Acronym
Effects of pain education on patients with chronic low back pain
Scientific Title
Pain Neuroscience Education for Patients With Chronic Low Back Pain. A Double-Blind Randomized Controlled Trial
Scientific Title:Acronym
Pain Neuroscience Education for Patients With Chronic Low Back Pain
Region
| Japan |
Condition
Condition
low back pain
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effectiveness of neurophysiological-based pain education for people with low back pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pain intensity (pre, post, post 1y)
Key secondary outcomes
Pain Catastrophizing score, Fear-Avoidance Beliefs Questionnaire, Roland-Morris disability questionnaire, Timed UG and Go test, 30 chair stand test, Long-seat forward bending
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Pain Neuroscience Education and exercise(6 times, 3 months)
Interventions/Control_2
Biomechanics-based education and exercise(6 times, 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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
chronic low back pain
Key exclusion criteria
Participants will be excluded if they have a diagnosis of lumbar radiculopathy, are receiving any other treatment for their CLBP at the time of the study, or have pain because of tumors or infections, metastases, osteoporosis, inflammatory arthritis, or fractures. In addition, patients with known mental disorders diagnosed by a physician. Also they have serious cognitive disorder.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Teppei |
| Middle name | |
| Last name | Abiko |
Organization
Kyoto Tachibana University
Division name
Physical Therapy
Zip code
607-8175
Address
34 Yamada-Oyake Yamashina-ku Kyoto
TEL
075-571-1111
abiko@tachibana-u.ac.jp
Public contact
Name of contact person
| 1st name | Teppei |
| Middle name | |
| Last name | Abiko |
Organization
Kyoto Tachibana University
Division name
Physical Therapy
Zip code
607-8175
Address
34 Yamada-Oyake Yamashina-ku Kyoto
TEL
075-571-1111
Homepage URL
abiko@tachibana-u.ac.jp
Sponsor or person
Institute
Kyoto Tachibana University
Institute
Department
Personal name
Funding Source
Organization
Kyoto Tachibana University
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
Kyoto Tachibana University
Address
34 Yamada-Oyake Yamashina-ku Kyoto
Tel
075-571-1111
aca-ext@tachibana-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 | 06 | Month | 04 | 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
120
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
| 2015 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 04 | Day |
Last modified on
| 2024 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050762
