UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043943 |
|---|---|
| Receipt number | R000050187 |
| Scientific Title | Investigation of central sensitization and rehabilitation methods for patients with musculoskeletal pain disorders |
| Date of disclosure of the study information | 2021/04/16 |
| Last modified on | 2024/04/19 11:07:43 |
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Basic information
Public title
The effect of various body-related symptoms on pain
Acronym
The effect of various body-related symptoms on pain
Scientific Title
Investigation of central sensitization and rehabilitation methods for patients with musculoskeletal pain disorders
Scientific Title:Acronym
Examination of central sensitization and rehabilitation of musculoskeletal pain
Region
| Japan |
Condition
Condition
musculoskeletal pain
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the longitudinal data of interventions for musculoskeletal pain patients, and to develop neuroscience-based hybrid rehabilitation for subjects with no analgesic effect, and to examine the effect of the interventions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Numerical Rating Scale(NRS):rest pain, motion pain, night pain
Baseline and 1 month follow up
Key secondary outcomes
Short-Form McGill Pain Questionnaire 2
Central Sensitization Inventory-9
Pain Catastrophizing Scale-6
The Fremantle Back Awareness Questionnaire
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Musculoskeletal pain patients
Key exclusion criteria
Difficulty in answering questions
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hayato |
| Middle name | |
| Last name | Shigetoh |
Organization
Neurorehabilitation Research Center, Kio University
Division name
Neurorehabilitation Research Center, Kio University
Zip code
635-0832
Address
Koryo-cho, Kitakaturagi-gun, Nara,Japan
TEL
0745541601
hayato.pt1121@gmail.com
Public contact
Name of contact person
| 1st name | Hayato |
| Middle name | Shigetoh |
| Last name | Shigetoh |
Organization
Neurorehabilitation Research Center, Kio University
Division name
Neurorehabilitation Research Center, Kio University
Zip code
635-0832
Address
Koryo-cho, Kitakaturagi-gun, Nara,Japan
TEL
0745541601
Homepage URL
hayato.pt1121@gmail.com
Sponsor or person
Institute
Neurorehabilitation Research Center, Kio University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Neurorehabilitation Research Center, Kio University
Address
Koryo-cho, Kitakaturagi-gun, Nara,Japan
Tel
0745541601
hayato.pt1121@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
| 2021 | Year | 04 | Month | 16 | Day |
Related information
URL releasing protocol
https://www.nature.com/articles/s41598-024-55290-4
Publication of results
Published
Result
URL related to results and publications
https://www.nature.com/articles/s41598-024-55290-4
Number of participants that the trial has enrolled
435
Results
Patients were classified into four groups (mild pain/CSS, severe pain/mild CSS, severe pain/CSS, and mild pain/severe CSS groups). Adjusted residual chi-square analysis showed that pain was worse in the mild and severe CSS groups.
Results date posted
| 2024 | Year | 04 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Involved 435 inpatients or outpatients drawn from multi-site clinics and hospitals
Inclusion criteria: patients with musculoskeletal pain
Exclusion criteria: patients diagnosed with dementia or significant higher brain dysfunction who had difficulty completing the questionnaire
Participant flow
All patients completed a questionnaire at baseline.
All patients received the same categories of physical therapy (manual therapy, exercise, and education).
One month later, subjects were reassessed.
Adverse events
No
Outcome measures
Age, sex, pain duration, NRS, and SFMPQ-2 for pain intensity, CSI-9 for CSS, PCS-6 for pain catastrophizing, and Fremantle score for body perception disturbance.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Questionnaire evaluation
Management information
Registered date
| 2021 | Year | 04 | Month | 16 | Day |
Last modified on
| 2024 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050187
