UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051299 |
|---|---|
| Receipt number | R000058513 |
| Scientific Title | Central sensitization and sensory processing function in patients with musculoskeletal pain disorders and its impact on quality of life, and rehabilitation methods. |
| Date of disclosure of the study information | 2023/06/09 |
| Last modified on | 2023/06/08 19:45:18 |
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Basic information
Public title
Central sensitization and sensory processing function in patients with musculoskeletal pain disorders and its impact on quality of life, and rehabilitation methods.
Acronym
Central sensitization and the impact of sensory processing function on quality of life
Scientific Title
Central sensitization and sensory processing function in patients with musculoskeletal pain disorders and its impact on quality of life, and rehabilitation methods.
Scientific Title:Acronym
Central sensitization and the impact of sensory processing function on quality of life
Region
| Japan |
Condition
Condition
Musculoskeletal pain
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate how central sensitization syndrome and decreased sensory gating function are related to decreased quality of life in patients with musculoskeletal pain, to develop a neuroscience-based hybrid rehabilitation focusing on sensory gating function, and to examine the effectiveness of this intervention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EuroQol 5-dimension
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom | Maneuver |
| Other |
Interventions/Control_1
Stretching, muscle strengthening exercise, aerobic exercise, patient education, desensitization through sensory input, neurorehabilitation such as sensory discrimination tasks, work activities, etc.
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
Painful
Key exclusion criteria
Difficult to assess by questionnaire
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hayato |
| Middle name | |
| Last name | Shigetoh |
Organization
Kio University
Division name
Neurorehabilitation Research Center
Zip code
635-0832
Address
4 Chome-2-2 Umaminaka, Koryo, Kitakatsuragi District, Nara
TEL
0745541601
hayato.pt1121@gmail.com
Public contact
Name of contact person
| 1st name | Hayato |
| Middle name | |
| Last name | Shigetoh |
Organization
Kio University
Division name
Neurorehabilitation Research Center
Zip code
635-0832
Address
4 Chome-2-2 Umaminaka, Koryo, Kitakatsuragi District, Nara
TEL
0745541601
Homepage URL
hayato.pt1121@gmail.com
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio University
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
Kio University, Neurorehabilitation Research Center
Address
4 Chome-2-2 Umaminaka, Koryo, Kitakatsuragi District, Nara
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
| 2023 | Year | 06 | Month | 09 | 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
Results
Results date posted
Results Delayed
Results Delay Reason
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
| 2023 | Year | 06 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 06 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 08 | Day |
Last modified on
| 2023 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058513
