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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003418
Receipt No. 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

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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
Email

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
Email skoji@medistatlab.com

Sponsor
Institute The Japanese Society for Spine Surgery and Related Research
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004140

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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