UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000033412 |
|---|---|
| Receipt number | R000038094 |
| Scientific Title | Investigation of the effects of open-label placebos on patients with chronic low back pain |
| Date of disclosure of the study information | 2018/07/17 |
| Last modified on | 2021/01/17 10:05:41 |
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Basic information
Public title
Investigation of the effects of open-label placebos on patients with chronic low back pain
Acronym
Trial of open-label placebos to patients with chronic low back pain
Scientific Title
Investigation of the effects of open-label placebos on patients with chronic low back pain
Scientific Title:Acronym
Trial of open-label placebos to patients with 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 aim of this study is to investigate the efficacy and its substantivity on patients with chronic low back pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Pain intensity:Numerical rating scale.
Pain disability:Roland-Morris Disability Questionnaire.
Key secondary outcomes
Timed up and go test
Subjective satisfaction scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Open label placebo capsule with sufficient information
Taking 2 capsules/time, morning & evening /day with confirming the effect of placebo
Outcomes are assessed at baseline, 3 week and 3 months
Interventions/Control_2
Usual treatment
Outcomes are assessed at baseline, 3 week and 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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Chronic low back pain
1)Pain is lasting for more than 6 months
2)Subjective pain magnitude is at least 3 out of 0-10 numerical rating scale
Key exclusion criteria
1)No wish toparticipation
2)Pain radiating into lower leg
3)On going treatment of malignant tumor, spinal fractures and spinal infections
4)Autoimmune diseases
5)Spondyloarthropathy
6)Elderly aged 75 years and older whose Tscore of DXA is lower than 2.5
7)Histories of fragile spinal fractures
8)Histories or use of steroids for more than 3 months.
9)Spinal kyphosis or spinal scoliosis whose cobb angle is over 30 degree
10)Within 3 months after thoracic or lumbar surgeries
11)Taking medicaion associated with dementia
12)Suspicious cognitive disorder
13)Judged ineligible by the researchers
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Tatsunori |
| Middle name | |
| Last name | Ikemoto |
Organization
Aichi medical university
Division name
Department of Orthopedic Surgery
Zip code
480-1195
Address
1-1 Yazako Karimata, Nagakute, Aichi
TEL
0561631087
tatsunon31-ik@umin.ac.jp
Public contact
Name of contact person
| 1st name | Tatsunori |
| Middle name | |
| Last name | Ikemoto |
Organization
Aichi medical university
Division name
Department of Orthopedic Surgery
Zip code
480-1195
Address
1-1 Yazako Karimata, Nagakute, Aichi
TEL
0561631087
Homepage URL
tatsunon31-ik@umin.ac.jp
Sponsor or person
Institute
Department of Orthopedic Surgery, Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopedic Surgery, Aichi Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Medical University
Address
1-1 Yazako Karimata, Nagakute, Aichi, 480-1195, Japan.
Tel
0561-62-3311
tatsunon31-ik@umin.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
愛知医科大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.hindawi.com/journals/prm/2020/6636979/
Number of participants that the trial has enrolled
52
Results
The present study investigated whether the OLP+TAU treatment was effective for Japanese patients with CLBP under the assumption of equal efficacy as in the previous reports. Our results revealed that OLP+TAU showed no significant superior benefit in comparison with TAU alone after 3- and 12-week interventions for Japanese patients with CLBP although significant improvements in functional disability were obtained in both groups at week 12.
Results date posted
| 2021 | Year | 01 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 12 | Month | 28 | Day |
Baseline Characteristics
Of the 52 patients, 32 (68.2%) were women and the mean age (SD) was 66.8 (13.4) years.
Participant flow
Between August 2018 and March 2020, 70 patients with CLBP were initially referred to as the primary investigator, and 18 patients were excluded due to the eligibility criteria.
Adverse events
Adverse events were not observed in the study participants.
Outcome measures
Plan to share IPD
The data used to support the findings of this study are available from the corresponding author upon request.
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 08 | Month | 20 | Day |
Date trial data considered complete
| 2020 | Year | 08 | Month | 20 | Day |
Date analysis concluded
| 2020 | Year | 09 | Month | 28 | Day |
Other
Other related information
https://www.hindawi.com/journals/prm/2020/6636979/
Management information
Registered date
| 2018 | Year | 07 | Month | 17 | Day |
Last modified on
| 2021 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038094
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