UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046899 |
|---|---|
| Receipt number | R000053298 |
| Scientific Title | Central Sensitization Inventory and Pressure Pain Threshold in Pain Educated Patients with Chronic Low Back Pain: A Mediation Analysis of the CSSTE Study |
| Date of disclosure of the study information | 2022/02/15 |
| Last modified on | 2026/01/20 18:19:10 |
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Basic information
Public title
Central Sensitization Inventory and Pressure Pain Threshold in Pain Educated Patients with Chronic Low Back Pain: A Mediation Analysis of the CSSTE Study
Acronym
Central Sensitization Inventory and Pressure Pain Threshold in Pain Educated Patients with Chronic Low Back Pain
Scientific Title
Central Sensitization Inventory and Pressure Pain Threshold in Pain Educated Patients with Chronic Low Back Pain: A Mediation Analysis of the CSSTE Study
Scientific Title:Acronym
Central Sensitization Inventory and Pressure Pain Threshold in Pain Educated Patients with Chronic Low Back Pain
Region
| Japan |
Condition
Condition
Chronic low back pain
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To provide pain education to patients with chronic low back pain in response to the Central Sensitization Inventory (CSI) and to investigate factors that mediate the reduction of ability impairment.
Basic objectives2
Others
Basic objectives -Others
Efficacy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Roland-Morris Disability Questionnaire
Key secondary outcomes
Central Sensitization Inventory
Pressure Pain threshold
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Pain education and exercise therapy using an illustrated booklet for Central Sensitivity Syndrome
12 weeks
Interventions/Control_2
Pain education and exercise therapy using illustrated booklets based on Pain Neuroscience Education
12 weeks
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Chronic low back pain for more than 3 months
(2) Pain intensity 3/10 on a numerical rating scale for average pain in the past week
Key exclusion criteria
(1) Specific pain-related symptoms (neuropathic pain, fracture, rheumatic disease, history of lumbar surgery in the last 3 years, fibromyalgia, complex regional pain syndrome)
(2) Unable to follow the study schedule
(3) Compensation for Absence from Work
(4) Unable to read or write in Japanese
(5) Serious cognitive problems
(6) During pregnancy
(7) Having received a form of pain neuroscience education in the past
Target sample size
104
Research contact person
Name of lead principal investigator
| 1st name | Tomohiko |
| Middle name | |
| Last name | Nishigami |
Organization
Prefectural University of Hiroshima
Division name
Department of Physical Therapy, Faculty of Health and Welfare
Zip code
723-0053
Address
1-1 Gakuen-tyou, Mihara, Hiroshima
TEL
0848-60-1120
tomon@pu-hirosima.ac.jp
Public contact
Name of contact person
| 1st name | Hirofumi |
| Middle name | |
| Last name | Yamashita |
Organization
SKY clinic
Division name
Department of Rehabilitation
Zip code
567-0829
Address
Ibaraki Higashi Hankyu Bldg. 1F, 10-1, Futaba-cho, Ibaraki, Osaka
TEL
072-638-7676
Homepage URL
yamashita.hf@gmail.com
Sponsor or person
Institute
SKY clinic
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
Prefectural University of Hiroshima
Address
1-1 Gakuen-tyou, Mihara, Hiroshima
Tel
0848-60-1120
tomon@pu-hirosima.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
| 2022 | Year | 02 | Month | 15 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 14 | Day |
Last modified on
| 2026 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053298
