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 | 2025/08/22 12:53:23 |
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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
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
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
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
Approximately 200 patients with neck pain who visit the outpatient department of the orthopedic clinic will be included in this study. Eligible participants will be those aged between 20 and 80 years who provide written informed consent after receiving a full explanation of the study.
Participants will be excluded if they have a history of psychiatric disorders; if they have severe spinal or spinal cord pathology (e.g., cancer, tumor, or fracture); or if they have undergone previous surgery involving the cervical spine or spinal cord.
Participant flow
Patients currently receiving outpatient care, as well as new outpatients, will be screened according to the inclusion criteria. The purpose of the study and the protection of personal information will be explained, and written informed consent will be obtained from those who agree to participate.
Subsequently, various evaluation measures and imaging data will be collected, and the obtained information will be analyzed and interpreted.
Adverse events
Outcome measures
Participant characteristics, including sex, age, height, and employment status, were obtained through a self-administered questionnaire.
At the initial assessment, condition-specific questionnaires were used to evaluate disability, pain intensity, body perception disturbance, catastrophic thinking, fear of movement, and perceived injustice.
In addition, physical function was assessed by measuring cervical range of motion, and structural evaluations were conducted using plain radiographs to assess vertebral degeneration, spinal canal stenosis ratio, and sagittal alignment.
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
| 2025 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043012
