UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003418 |
|---|---|
| Receipt number | R000004140 |
| Scientific Title | Prevalence of Neuropathic Pain in the Patients with Chronic Pain Associated with Spinal Diseases. |
| Date of disclosure of the study information | 2010/04/01 |
| Last modified on | 2012/04/20 09:46:33 |
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Basic information
Public title
Prevalence of Neuropathic Pain in the Patients with Chronic Pain Associated with Spinal Diseases.
Acronym
Prevalence of Neuropathic Pain in the Patients with Chronic Pain Associated with Spinal Diseases.
Scientific Title
Prevalence of Neuropathic Pain in the Patients with Chronic Pain Associated with Spinal Diseases.
Scientific Title:Acronym
Prevalence of Neuropathic Pain in the Patients with Chronic Pain Associated with Spinal Diseases.
Region
| Japan |
Condition
Condition
Chronic pain associated with spinal diseases
Classification by specialty
| Surgery in general | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Aim of this cross sectional survey is to investigate the prevalence of neuropathic pain in the patients with chronic pain associated with spinal diseases by use of the neuropathic pain screening questioner.
Basic objectives2
Others
Basic objectives -Others
Prevalence
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Prevalence of neuropathic pain
Key secondary outcomes
Quality of life impairment
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. 20 to 79 years old men and women
2. Patients with chronic pain associated with spinal diseases.
3. Patients with 30 or more pain intensity in visual analogue scale, previous 1 week from day of informed consent.
4. Patients be able read and write Japanese questioner without any assistants.
Key exclusion criteria
1. Patients had not been treated neurolytic block previous 6 months from day of informed consent.
2. Patients with other origin of pain
3. In hospital patients
4. Patients with severe paralysis
5. Patients lack of ability to understand informed consent.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiko Yamashita |
Organization
Sapporo Medical University School of Medicine
Division name
Orthopaedic Surgery
Zip code
Address
South-1, West-16, Cyuo-ku, Sapporo 060-8543
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Shimamoto |
Organization
MediStatLab Co., LTD
Division name
President
Zip code
Address
TEL
Homepage URL
http://www.medistatlab.com/JSSR/Home.html
skoji@medistatlab.com
Sponsor or person
Institute
The Japanese Society for Spine Surgery and Related Research
Institute
Department
Personal name
Funding Source
Organization
Pfizer Japan Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
札幌医科大学医学部附属病院 他 全国約150施設
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2010 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 03 | Month | 01 | Day |
Other
Other related information
Neuropatic Pain Screening Questionnaire and SF-36
Prevalence of neuropathic pain will be calculated in the subgroup which categorized sex, age and etc. In addition, exploratory data analyses will be done to identify the relationships between characteristics of pain or patients back ground and pain intensity or QOL impairment.
Management information
Registered date
| 2010 | Year | 03 | Month | 31 | Day |
Last modified on
| 2012 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004140
| 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 |
