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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000005959 |
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Date of registration:
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12/07/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Prospective clinical study of the therapeutic effects of prostaglandin in patients with combined lumbar spinal stenosis and arteriosclerosis obliterans showing intermittent claudication
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Scientific title:
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Prospective clinical study of the therapeutic effects of prostaglandin in patients with combined lumbar spinal stenosis and arteriosclerosis obliterans showing intermittent claudication - Clinical study on therapeutic effects of prostaglandin in patients with combined lumbar spinal stenosis and arteriosclerosis obliterans |
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Date of first enrolment:
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2010/11/04 |
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Target sample size:
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300 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007018 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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MASATO SATO,M.D.,Ph.D. |
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Address:
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143,Shimokasuya,Isehara,Kanagawa,259-1193,Japan
Japan |
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Telephone:
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0463-93-1121 |
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Email:
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Affiliation:
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Tokai University School of Medicine Department of Orthopaedic Surgery |
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Name:
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MASATO SATO,M.D.,Ph.D. |
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Address:
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143,Shimokasuya,Isehara,Kanagawa,259-1193,Japan
Japan |
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Telephone:
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0463-93-1121 |
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Email:
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Affiliation:
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Tokai University School of Medicine Department of Orthopaedic Surgery |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: The patients who meet any of the following exclusion criteria are excluded. 1) Patients who have ethical difficulties due to special consideration required for them or their family. 2) Patients with diabetes, chronic renal failure, etc. who are suspected to have a complication of peripheral nerve disorder or circulatory disorder. 3) Patients who are receiving administration of anticoagulant, etc. 4) Patients who have a history of surgical treatment for the spine/spinal cord. 5) Patients who have problematic infection. 6) Patients who do not understand the objectives of this study.
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Patients with combined lumbar spinal stenosis and arteriosclerosis obliterans
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Intervention(s)
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Prostaglandin for injection (alprostadil) group: 60 mcg of prostaglandin for injection is intravenously administered once a week or more. This therapy is repeated 10 times or more.
Ripple injection (alprostadil Injection) group: 10 mcg of ripple injection is administered intravenously once a week or more. This treatment is repeated 10 times or more.
Conventional treatment group
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Primary Outcome(s)
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The Japanese Orthopaedic Association (JOA) score
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Secondary Outcome(s)
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Age, sex, affected period, biochemical examination of blood, details of treatment (number and frequency of infusions, concomitant drug therapy, block therapy, and other conservative therapies), SF-36, VAS
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Source(s) of Monetary Support
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Tokai University Hospital Department of Orthopaedic Surgery
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Ethics review
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Status: YES
Approval date: 04/11/2010
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/03/2018 |
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URL:
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