UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037718
Receipt number R000043012
Scientific Title Clinical study on prognostic factors in patients with neck pain
Date of disclosure of the study information 2019/09/01
Last modified on 2024/02/20 23:44:33

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Basic information

Public title

Clinical study on prognostic factors in patients with neck pain

Acronym

Clinical study on prognostic factors in patients with neck pain

Scientific Title

Clinical study on prognostic factors in patients with neck pain

Scientific Title:Acronym

Clinical study on prognostic factors in patients with neck pain

Region

Japan


Condition

Condition

Whiplash associated disorders, non-specific neck pain

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to investigate factors that affect the pain intensity and disability in patients with neck pain from a multi-faceted perspective of bio-psychosocial models.

Basic objectives2

Others

Basic objectives -Others

The clinical prediction

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase



Assessment

Primary outcomes

Evaluate Pain Intensity and Neck Disability Index at 3 or 6 months after initial visit.

Key secondary outcomes

Fremantle neck awareness questionnaire, Tampa scale for kinesiofobia, Pain catastrophizing scale


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

80 years-old >

Gender

Male and Female

Key inclusion criteria

Older than 18 and younger than 80 years, patients with unilateral or bilateral neck pain.

Key exclusion criteria

Any neurological disorders, problems with vision and hearing, vestibular pathology, or other neurological deficits, had undergone any previous spinal surgery, were diagnosed with serious spinal pathology (cancer, inflammatory arthropathy, or acute vertebral fracture), or were currently pregnant.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Yuh
Middle name
Last name Yamashita

Organization

Morinaga orthopedic clinic, Medical Corporation

Division name

Department of rehabilitation

Zip code

8490934

Address

Kaisei 14-48, Saga-city, Saga 849-0934, Japan

TEL

08039085904

Email

yuhyou6@gmail.com


Public contact

Name of contact person

1st name Yuh
Middle name
Last name Yamashita

Organization

Morinaga orthopedic clinic, Medical Corporation

Division name

Department of rehabilitation

Zip code

8490934

Address

Kaisei 14-48, Saga-city, Saga 849-0934, Japan

TEL

08039085904

Homepage URL


Email

yuhyou6@gmail.com


Sponsor or person

Institute

Morinaga orthopedic clinic, Medical Corporation

Institute

Department

Personal name



Funding Source

Organization

The research fund of Nagasaki University Graduate School

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

Community-based Rehabilitation Sciences,Nagasaki University Graduate School of Biomedical Sciences

Address

1-7-1 Sakamoto, Nagasaki 852-8520, Japan

Tel

0958197904

Email

yuhyou6@gmail.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

2019 Year 09 Month 01 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

340

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

We are analyzing the data obtained longitudinally.

Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2018 Year 06 Month 01 Day

Date of IRB

2019 Year 07 Month 01 Day

Anticipated trial start date

2019 Year 09 Month 01 Day

Last follow-up date

2022 Year 03 Month 30 Day

Date of closure to data entry

2022 Year 09 Month 30 Day

Date trial data considered complete

2023 Year 12 Month 01 Day

Date analysis concluded

2024 Year 05 Month 01 Day


Other

Other related information

To investigate changes in physical function, cognitive function, and psychological function from the onset to the end of treatment in patients with cervical pain from a biopsychosocial perspective, and to extract factors that affect patient pain and disability.


Management information

Registered date

2019 Year 08 Month 18 Day

Last modified on

2024 Year 02 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043012


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name