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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000044678
Receipt No. R000051027
Scientific Title Comparative effects of cognitive functional therapy and movement system impairment-based treatment in patients with low back pain
Date of disclosure of the study information 2021/07/05
Last modified on 2021/06/28

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Basic information
Public title Comparative effects of cognitive functional therapy and movement system impairment-based treatment in patients with low back pain
Acronym Comparative effects of cognitive functional therapy and movement system impairment-based treatment in patients with low back pain
Scientific Title Comparative effects of cognitive functional therapy and movement system impairment-based treatment in patients with low back pain
Scientific Title:Acronym Comparative effects of cognitive functional therapy and movement system impairment-based treatment in patients with low back pain
Region
Asia(except Japan)

Condition
Condition pre to post intervention
Classification by specialty
Rehabilitation medicine Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparative effects of cognitive functional therapy and movement system impairment-based treatment in patients with low back pain
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Numeric Ratings Scale (NRS)
Key secondary outcomes disability, Kinesiophobia, and vertical ground reaction force (VGRF) parameters assessed by Oswestry Disability Indext (ODI), Tampa Kinesiophobia Scale (TKI), and (Force distributor treadmill)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Cognitive functional therapy
Interventions/Control_2 Movement system impairm18ent-based treatment
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
18 years-old <=
Age-upper limit
65 years-old >=
Gender Female
Key inclusion criteria Patients with NSCLBP (according to the criteria of the International Classification of Diseases, 10th Revision [ICD-10]) for more than 3 months and over 18 years of age were eligible to participate this study
Key exclusion criteria have neurological disorders, spinal pathologies structural deformity, osteoporosis, inflammatory disorder (e.g. spondylitis), radicular syndrome, history of tumor and fracture in spine, true leg length discrepancy more than 20 mm, pregnancy, or BMI of greater than 30 kg/m2
Target sample size 135

Research contact person
Name of lead principal investigator
1st name Pouya
Middle name
Last name Rabiei
Organization Kharazmi university
Division name Sport medicine
Zip code 6664743
Address tehran
TEL 00989195394692
Email pouya.rabiei.pr@gmail.com

Public contact
Name of contact person
1st name amir
Middle name
Last name letafatkar
Organization Kharazmi University
Division name sport medicine
Zip code 6664743
Address tehran
TEL 00989357465993
Homepage URL
Email letafatkaramir@yahoo.com

Sponsor
Institute kharazmi university
Institute
Department

Funding Source
Organization self 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 university
Address tehran
Tel 982122258085
Email letafatkaramir@yahoo.com

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
2021 Year 07 Month 05 Day

Related information
URL releasing protocol Table 1. Between-group differences at baseline Clinical and sociodemographic features CFT (N=45) MSI
Publication of results Unpublished

Result
URL related to results and publications Table 1. Between-group differences at baseline Clinical and sociodemographic features CFT (N=45) MSI
Number of participants that the trial has enrolled 91
Results
Mean age (SD), years 26.00 (3.17) 27.17(5.10) 0.19a
Mean height (SD), cm 164.11(4.22) 163.36(3.28) 0.35a
Mean weight (SD), kg 67.40(9.30) 65.04(7.50) 0.18a
Mean BMI (kg/m2) 25.00(3.09) 24.37(2.75) 0.31a
Mean duration of LBP (SD), months 8.80 (2.07) 8.43 (1.64) 0.37a
Results date posted
2021 Year 06 Month 28 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Clinical and sociodemographic features CFT (N=45) MSI (N=46) P
Participant flow no
Adverse events no
Outcome measures no
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2018 Year 04 Month 01 Day
Date of IRB
2018 Year 08 Month 25 Day
Anticipated trial start date
2018 Year 09 Month 21 Day
Last follow-up date
2019 Year 03 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 06 Month 28 Day
Last modified on
2021 Year 06 Month 28 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051027

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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