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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033412
Receipt No. 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 2018/08/16

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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 Exploratory
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 No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 3
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 month
Interventions/Control_2 Open label placebo capsule without sufficient information
Taking 2 capsules/time, morning & evening /day
Outcomes are assessed at baseline, 3 week and 3 month
Interventions/Control_3 Normal treatment
Outcomes are assessed at baseline, 3 week and 3 month
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 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsunori Ikemoto
Organization Aichi Medical University
Division name Department of Orthopedic Surgery
Zip code
Address 1-1 Yazako Karimata, Nagakute, Aichi
TEL 0561-63-1087
Email tatsunon31-ik@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsunori Ikemoto
Organization Aichi Medical University
Division name Department of Orthopedic Surgery
Zip code
Address 1-1 Yazako Karimata, Nagakute, Aichi
TEL 0561-63-1087
Homepage URL
Email tatsunon31-ik@umin.ac.jp

Sponsor
Institute Department of Orthopedic Surgery, Aichi Medical University
Institute
Department

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
Address
Tel
Email

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 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 Enrolling by invitation
Date of protocol fixation
2018 Year 07 Month 13 Day
Date of IRB
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
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 03 Month 31 Day
Date analysis concluded
2021 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2018 Year 07 Month 17 Day
Last modified on
2018 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038094

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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