UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047455 |
|---|---|
| Receipt number | R000054114 |
| Scientific Title | Comparison of cognitive functional therapy and movement system impairment treatment in chronic low back pain patients |
| Date of disclosure of the study information | 2022/11/10 |
| Last modified on | 2023/03/12 23:19:30 |
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Basic information
Public title
Comparison of cognitive functional therapy and movement system impairment treatment in chronic low back pain patients
Acronym
Comparison of cognitive functional therapy and movement system impairment treatment in chronic low back pain patients
Scientific Title
Comparison of cognitive functional therapy and movement system impairment treatment in chronic low back pain patients
Scientific Title:Acronym
Comparison of cognitive functional therapy and movement system impairment treatment in chronic low back pain patients
Region
| Asia(except Japan) |
Condition
Condition
pretest- post test- 6month follow up
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of cognitive functional therapy and movement system impairment treatment in chronic low back pain patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pain intensity measured by Numeric Ratings Scale (NRS)
Key secondary outcomes
disability, Kinesiophobia, and 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
Individual
Blinding
Single blind -investigator(s) and 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 impairment
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with CNSLBP (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
The patients were excluded if found to 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, or BMI of greater than 30 kg/m2.
Target sample size
91
Research contact person
Name of lead principal investigator
| 1st name | amir |
| Middle name | |
| Last name | letafatkar |
Organization
Kharazmi University
Division name
Sport medicine
Zip code
6664743
Address
tehran
TEL
00989195394692
letafatkaramir@yahoo.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 Unuversity
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
Tarbiat Modarres University
Address
Gisha
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
| 2022 | Year | 11 | Month | 10 | 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
109
Results
-
Results date posted
| 2022 | Year | 04 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
-
Participant flow
-
Adverse events
NA
Outcome measures
-
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 11 | Day |
Last modified on
| 2023 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054114
