UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051341 |
|---|---|
| Receipt number | R000058557 |
| Scientific Title | Characteristics of the perception of central sensitization symptoms in patients with chronic pain: A mixed methods approach |
| Date of disclosure of the study information | 2023/06/15 |
| Last modified on | 2023/08/29 11:34:46 |
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Basic information
Public title
Characteristics of the perception of central sensitization symptoms in patients with chronic pain: A mixed methods approach
Acronym
Characteristics of the perception of central sensitization syndrome in patients with chronic pain
Scientific Title
Characteristics of the perception of central sensitization symptoms in patients with chronic pain: A mixed methods approach
Scientific Title:Acronym
Characteristics of the perception of central sensitization symptoms in patients with chronic pain
Region
| Japan |
Condition
Condition
chronic musculoskeletal pain
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate, using a mixed methods approach, whether there is a difference in perception between those who had an intervention targeting the central sensitization syndrome and those who did not have a good improvement.
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Semi-structured interview data
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Chronic low back pain for more than 3 mont hs
(2) Pain intensity 3/10 on a numerical rating sca le for average pain in the past week
Key exclusion criteria
(1) Specific pain-related symptoms (neuropathic pain, fracture, rheumatic disease, history of lum bar surgery in the last 3 years, fibromyalgia, co mplex regional pain syndrome)
(2) Unable to follow the study schedule
(3) Compensation for Absence from Work
(4) Unable to read or write in Japanese
(5) Serious cognitive problems
(6) During pregnancy
(7) Having received a form of pain neuroscience education in the past
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomohiko |
| Middle name | |
| Last name | Nishigami |
Organization
Prefectural University of Hiroshima
Division name
Department of Physical Therapy, Faculty of Health and Welfare
Zip code
723-0053
Address
1-1 Gakuen-tyou, Mihara, Hiroshima
TEL
0848-60-1120
tomon@pu-hirosima.ac.jp
Public contact
Name of contact person
| 1st name | Hirofumi |
| Middle name | |
| Last name | Yamashita |
Organization
Nozomi Orthopedic Clinic Saijo
Division name
Department of Rehabilitation
Zip code
739-0021
Address
1182-1, Saijochosukezane Higashihiroshima Hir oshima
TEL
082-422-6000
Homepage URL
yamashita.hf@gmail.com
Sponsor or person
Institute
Nozomi Orthopedic Clinic Saijo
Institute
Department
Personal name
Funding Source
Organization
Prefectural University of Hiroshima
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
Prefectural University of Hiroshima
Address
1-1 Gakuen-tyou, Mihara, Hiroshima
Tel
0848-60-1120
tomon@pu-hirosima.ac.jp
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 | 15 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate, using a mixed methods approach, whether there is a difference in perception between those who had an intervention targeting the central sensitization syndrome and those who did not have a good improvement.
Management information
Registered date
| 2023 | Year | 06 | Month | 14 | Day |
Last modified on
| 2023 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058557
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
