UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044678 |
|---|---|
| Receipt number | 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 04:28:43 |
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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
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
letafatkaramir@yahoo.com
Sponsor or person
Institute
kharazmi university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051027
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
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