UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029424
Receipt No. 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 2019/04/07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email takashi_net184@yahoo.co.jp

Sponsor
Institute Wajinkai hospital
Department of Rehabilitation
Institute
Department

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
Email 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 No longer recruiting
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 04 Day
Last modified on
2019 Year 04 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033624

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.