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

Email

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


Email

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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name