UMIN-CTR Clinical Trial

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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051027