UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029424 |
|---|---|
| Receipt number | R000033624 |
| Scientific Title | Effects using attentional bias modification for the elderly people with chronic low back pain at outpatient |
| Date of disclosure of the study information | 2017/10/04 |
| Last modified on | 2019/11/13 21:15:30 |
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Basic information
Public title
Effects using attentional bias modification for the elderly people with chronic low back pain at outpatient
Acronym
Effects using attentional bias modification for the elderly people with chronic low back pain at outpatient
Scientific Title
Effects using attentional bias modification for the elderly people with chronic low back pain at outpatient
Scientific Title:Acronym
Effects using attentional bias modification for the elderly people with chronic low back pain at outpatient
Region
| Japan |
Condition
Condition
chronic low back pain
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate changes in the degree of pain and psychological indicators when performing ABM at hospital visits of patients with chronic low back pain and clarify whether back pain improves
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Degree of pain(Numerical Rating Scale:NRS)
Key secondary outcomes
Fear-Avoidance Beliefs Questionnaire(FABQ),Pain Catastrophizing Scale(PCS),Hospital Anxiety and Depression Scale (HADS),Somatic Symptom Scale - 8(SSS-8)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
ABM
period:twice per week, 3 months
amount:10 minutes per one time
wash out period:1 week
ABM-wash out-hot pack
Interventions/Control_2
hot pack
period:twice per week, 3 months
amount:10 minutes per one time
wash out period:1 week
hot pack-wash out-ABM
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
| 65 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
6 months or more outpatient due to low back pain
65 years old and over 90 years old
Independence of ADL at home
Key exclusion criteria
MMSE 23 points or less
Physical therapist's direct intervention
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Hasegawa |
Organization
Wajinkai hospital
Division name
Department of Rehabilitation
Zip code
8510103
Address
96 Nakazato, Nagasaki 851-0103, Japan
TEL
095-839-2051
takashi_net184@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Hasegawa |
Organization
Wajinkai hospital
Division name
Department of Rehabilitation
Zip code
8510103
Address
96 Nakazato, Nagasaki 851-0103, Japan
TEL
095-839-2051
Homepage URL
takashi_net184@yahoo.co.jp
Sponsor or person
Institute
Wajinkai hospital
Department of Rehabilitation
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Wajinkai hospital Department of Rehabilitation
Address
96 Nakazato, Nagasaki 851-0103, Japan
Tel
095-839-2051
takashi_net184@yahoo.co.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
| 2017 | Year | 10 | 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
21
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
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 18 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 04 | Day |
Last modified on
| 2019 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033624
