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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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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT04611464 |
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Date of registration:
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09/10/2020 |
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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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Misoprostol for Spinal Stenosis
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Scientific title:
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Pain and Functional Outcomes With Misoprostol Treatment for Lumbar Spinal Stenosis |
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Date of first enrolment:
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July 11, 2019 |
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Target sample size:
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23 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT04611464 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adults aged 18 years or older.
- Previous diagnosis of lumbar spinal stenosis, mild-severe lumbar central canal
stenosis identified by MRI or CT scan.
- Symptoms:
- Lower extremity symptoms consistent with neurogenic claudication.
- Pain, weakness &/or numbness triggered by standing or walking, and relieved by
sitting.
- Must be able to read English and complete questionnaire.
- Was prescribed Misoprostol specifically for lumbar spinal stenosis.
Exclusion Criteria:
- Cognitive impairment that renders the patient unable to give informed consent or
provide accurate data
- Clinical co-morbidities that could interfere with the collection of data concerning
pain and function
- Severe vascular, pulmonary, or coronary artery disease that limits ambulation
including recent myocardial infarction (within 6 months)
- Spinal instability requiring surgical fusion
- Severe osteoporosis as defined by multiple compression fractures or a fracture at the
same level as the stenosis
- Metastatic cancer
- Excessive alcohol consumption or evidence of non-prescribed or illegal drug use
- Pregnancy
- Concordant pain with internal rotation of the hip (or known hip joint pathology)
- Active local or systemic infection
- Previous lumbar spine surgery
- Prisoners
- Use of misoprostol for any other indication then lumbar spinal stenosis
- Rheumatological disorders such as rheumatoid arthritis, psoriatic arthritis, systemic
lupus erythematosis.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Low Back Pain
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Lumbar Spinal Stenosis
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Intervention(s)
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Drug: Misoprostol
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Primary Outcome(s)
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Claudication Distance Assessment
[Time Frame: Change from baseline, after they have been treated with Misoprostol]
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Swiss Lumbar Spinal Stenosis Questionnaire(SSSQ)
[Time Frame: Once at baseline, after they have been treated with Misoprostol; SSSQ has not been collected previously]
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Oswestry Disability Index (ODI)
[Time Frame: Change from baseline, after they have been treated with Misoprostol]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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