UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017743 |
|---|---|
| Receipt number | R000020553 |
| Scientific Title | Clinical study of efficacy of pregabalin for peripheral neuropathic pain in patients with lumbar spinal stenosis |
| Date of disclosure of the study information | 2015/05/30 |
| Last modified on | 2015/05/30 14:01:41 |
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Basic information
Public title
Clinical study of efficacy of pregabalin for peripheral neuropathic pain in patients with lumbar spinal stenosis
Acronym
Clinical study of efficacy of pregabalin for peripheral neuropathic pain in patients with lumbar spinal stenosis
Scientific Title
Clinical study of efficacy of pregabalin for peripheral neuropathic pain in patients with lumbar spinal stenosis
Scientific Title:Acronym
Clinical study of efficacy of pregabalin for peripheral neuropathic pain in patients with lumbar spinal stenosis
Region
| Japan |
Condition
Condition
peripheral neuropathic pain in patients with lumbar spinal stenosis
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It was administered pregabalin for spinal canal stenosis patients diagnosed with peripheral neuropathic pain by questionnaire for screening MRI and neuropathic pain, spinal canal stenosis by performing the evaluation of the efficacy and safety to examine the possibility of a new conservative treatment for patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of pain NRS after baseline and pregabalin administered 6 weeks
Key secondary outcomes
1.after the baseline and pregabalin administration six weeks of the JOA Back Pain Evaluation Questionnaire
2.Comparison of sleep NRS after baseline and pregabalin administered 6 weeks
3.Comparison of intermittent claudication after baseline and pregabalin administered 6 weeks
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.20 years of age or 90 years of age or less
2.Diagnosed by spinal canal stenosis and MRI
3.More than one month of treatment with NSAID implementation
4.The baseline Numerical rating scale NRS 3
5.with normal renal function example creatinine clearance 60ml / min
6.Neuropathic pain screening questionnaire 6
7.leg pain
8.For this study participants that document consent of the person or Daidaku who has been obtained
Key exclusion criteria
1.Antidepressants, anti-epileptic drugs, it has been taking opioid
2.Registered before it conducted a nerve block within one month
3.To have, serious complications
4.Pregnancy / nursing women
5.The plan to epidural anesthesia within 6 weeks
6.Peripheral vascular disorders
7.Past history of malignancy within two years
8.Have a history of, spinal canal stenosis surgery
9.And other, cases attending physician was deemed inappropriate
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Takahashi |
Organization
Graduate school of medicine,
Chiba University
Division name
Department of Orthopaedic Surgery
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
0432262117
19501114@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiji Ohtori |
Organization
Graduate school of medicine,
Division name
Department of Orthopaedic Surgery
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
0432262117
Homepage URL
sohtri@faculty.chiba-u.jp
Sponsor or person
Institute
Department of Orthopeadic Surgery ,
Graduate school of medicine,
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopeadic Surgery ,
Graduate school of medicine,
Chiba University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 30 | 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
| 2011 | Year | 06 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Primary endpoint
Secondary endpoint
Safety evaluation item
Management information
Registered date
| 2015 | Year | 05 | Month | 30 | Day |
Last modified on
| 2015 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020553
