Misoprostol for Spinal Stenosis
Completed
Conditions studied: Lumbar Spinal Stenosis, Low Back Pain
In brief
This single-group cross-sectional cohort study will enroll approximately 25 patients at the North Texas VA Health Care System (VANTHCS) who have previously received off-label prescriptions of misoprostol for lumbar spinal stenosis for any duration and who are willing to provide verbal and informed consent. Patients will answer a questionnaire regarding pain and functional improvement especially in reference to misoprostol treatment. Patients will also be selected to have their walking tolerance (claudication distance) measured in an outpatient clinic setting to determine the severity of their lumbar spinal stenosis symptoms after having received misoprostol.
Key facts
- Study ID
- NCT04611464
- Run by
- Dallas VA Medical Center
- People needed
- 23
- Starts
- 2019-07-11
- Expected to finish
- 2020-06-01
- Last updated by the study team
- 2020-11-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Dallas VA Medical Center — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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