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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000033767
Receipt No. R000038517
Scientific Title Comparison of pain neuroscience education followed by motor control exercise with group-based exercise for chronic low back pain
Date of disclosure of the study information 2018/08/15
Last modified on 2020/04/25

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Basic information
Public title Comparison of pain neuroscience education followed by motor control exercise with group-based exercise for chronic low back pain
Acronym Comparison of pain neuroscience education followed by motor control exercise with group-based exercise for chronic low back pain
Scientific Title Comparison of pain neuroscience education followed by motor control exercise with group-based exercise for chronic low back pain
Scientific Title:Acronym Comparison of pain neuroscience education followed by motor control exercise with group-based exercise for chronic low back pain
Region
Asia(except Japan)

Condition
Condition others
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison of pain neuroscience education followed by motor control exercise with group-based exercise for chronic low back pain
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual analogue scale (VAS)
Roland Morris Disability Questionnaire (RMDQ)
Key secondary outcomes FABQ-W, Fear-Avoidance Beliefs

FABQ-PA, Fear-Avoidance Beliefs

PSEQ, Pain Self-Efficacy Questionnaire,

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 PNE+MCE group received 3 sessions PNE followed by 13 sessions of MCEs
Interventions/Control_2 GE group received no education and initiated 16 exercise sessions over an eight-week period
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
30 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria native male and female patients aged between 30 and 60 years,
having CLBP (> 3 months, typically located between the lower rib margins and the buttock creases
with no specific and determined patho-anatomical cause)
that diagnosed by an experienced physical therapist
Key exclusion criteria history of spinal surgery, history of neurological signs, specific spinal pathology (tumor,
infection,
fracture,
inflammatory disease),
any serious pathology or health condition that prevent active participants in an exercise program,
and receiving any intervention contraindicating to exercises (e.g., manual therapy, ultrasound, or shortwave therapy)
during the trial period
Target sample size 110

Research contact person
Name of lead principal investigator
1st name Amir
Middle name
Last name Letafatkar
Organization kharazmi university
Division name department of corrective exercises and sport injuries
Zip code 4352763633
Address tehran-mirdamad-sout razan street, faculty of PE
TEL 009802122258084
Email letafatkaramir@yahoo.com

Public contact
Name of contact person
1st name Amir
Middle name
Last name letafatkar
Organization kharazmi University
Division name department of biomechanics and sport injuries
Zip code 4353663663
Address tehran-mirdamad-sout razan street, faculty of PE
TEL 00989195394692
Homepage URL
Email letafatkaramir@yahoo.com

Sponsor
Institute kharazmi university
Institute
Department

Funding Source
Organization no funding
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization kharazmi u iversity
Address gisha bridge, jalal aleahmad , kharazmi university,tehran
Tel 982182883590
Email healthcontrol@kharazmi.ac.ir

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
2018 Year 08 Month 15 Day

Related information
URL releasing protocol not released
Publication of results Unpublished

Result
URL related to results and publications not released
Number of participants that the trial has enrolled 180
Results
Of 180 participants, 96.2% were followed up at 8 weeks 
Results date posted
2019 Year 08 Month 01 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
not released
Participant flow
not released
Adverse events
no
Outcome measures
not released
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2016 Year 09 Month 08 Day
Date of IRB
2017 Year 04 Month 05 Day
Anticipated trial start date
2017 Year 11 Month 18 Day
Last follow-up date
2018 Year 03 Month 11 Day
Date of closure to data entry
Date trial data considered complete
2019 Year 07 Month 10 Day
Date analysis concluded
2019 Year 10 Month 17 Day

Other
Other related information

Management information
Registered date
2018 Year 08 Month 15 Day
Last modified on
2020 Year 04 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038517

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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