Prospective clinical study of the therapeutic effects of prostaglandin in patients with combined lumbar spinal stenosis and arteriosclerosis obliterans showing intermittent claudication

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005959

Enrollment

300

Registered

2011-07-12

Start date

2010-11-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with combined lumbar spinal stenosis and arteriosclerosis obliterans

Interventions

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 (a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The subjects are patients who meet all of the following inclusion criteria and are able to provide informed consent. 1) Male and female patients aged 20 years or older. 2) Patients who are diagnosed with lumbar spinal stenosis based on X-ray and MRI findings and are undergoing conservative treatment. 3) Patients who are diagnosed with arteriosclerosis obliterans (peripheral arterial disease) Fontaine classification I or II. 4) Patients who understand the objectives of this study and provide informed consent.

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
The Japanese Orthopaedic Association (JOA) score	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactMASATO SATO,M.D.,Ph.D.

Tokai University School of Medicine Department of Orthopaedic Surgery

0463-93-1121

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026