- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04611464
Misoprostol for Spinal Stenosis
Pain and Functional Outcomes With Misoprostol Treatment for Lumbar Spinal Stenosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Lumbar spinal stenosis (LSS) is clinically described as a neurogenic claudication that is associated with increased mechanical compression on the spinal nerve roots as well as potential compromise of the vascular supply of the spinal nerve roots. This compression typically leads to symptoms of lumbar pseudoclaudication, which include pain, paresthesias, and discomfort in the lower extremities, commonly exacerbated by walking. Broadly speaking, this compression can be the result of a degenerative narrowing of the spinal or nerve root canals. While spinal stenosis is typically considered idiopathic, causes can also include malignancy, injury, and chronic inflammation. It is often debilitating to patients and can lead to a wide variety of negative health outcomes (pre-operative lower levels of function, psychological distress, high self-reported disability scores and operative risks of surgical correction) related to attempted surgical correction of lumbar spinal stenosis. Spinal stenosis continues to be a leading indication for spine surgery in adults older than 65 years old. Furthermore, estimated total Medicare costs for surgeries treating lumbar spinal stenosis amounted to over $1.65 billion for 37,598 individual operations.
Physiologically, the venous blood flow in the lumbar spinal region is disproportionately affected by pressure gradients generated secondary to normal movement and pathologic constriction. Studies have found that patients diagnosed with lumbar spinal stenosis with intermittent claudication, while walking on a treadmill, experienced larger amounts of vascular congestion which resolved with sitting. This was measured with a myeloscope in the intrathecal space.
The current vascular pathologic mechanism of the symptomatic effects of lumbar spinal stenosis is thought to be a consequence of constriction leading to increasing vascular congestion and inflammation. Authors first described the effect of constriction on vascular flow through a post mortem study of a patient with chronic lumbar spinal stenosis at L4-L5. Most significantly, they found that venous supply proximal to constriction in fact showed reduced and collapsed veins with gross congestion proximal to the lesion. Further investigation found that venous congestion led to increased inflammatory markers in nerves with atrophy, Wallerian degeneration, and perineural fibrosis in more severe patients. Most importantly, these pathologic changes were associated with vascular changes in the absence of direct nerve root compression at these sites. This venous congestion is a potential target for therapy.
There has been previous work done with medications that are PGE1 analogs such as limaprost and lipo-PGE1. PGE1 analogs hypothetically treat the above lumbar spinal stenosis pathology by improving blood flow to nerve roots through vasodilatory and antiplatelet aggregation effects. However, misoprostol (PGE1 analog) has not been thoroughly evaluated as a possible treatment for symptoms of lumbar spinal stenosis.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Texas
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Dallas, Texas, United States, 75216
- Dallas VA Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Single-group cross-sectional cohort
Patients 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. Once enrolled, patients will complete the Swiss Lumbar Spinal Stenosis Questionnaire (SSSQ) as well as the Oswestry Disability Index (ODI). The SSSQ will elicit patients' responses specifically related to their usage of misoprostol for lumbar spinal stenosis. Then their walking tolerance will be assessed by having them walk along a measured walkway of up to 500 feet to determine the onset of their neurogenic claudication symptoms at a certain distance, their claudication distance. Prescription information on dosage and frequency of misoprostol use, and any reported side effects with use of this medication, and any cessation or stoppage of use of this medication will all be recorded. |
Misoprostol is a PGE1 analog
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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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The SSSQ quantifies severity of symptoms, physical function characteristics, and patient's satisfaction after treatment.
|
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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The ODI quantifies disability dues to lumbar spinal stenosis symptoms
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Change from baseline, after they have been treated with Misoprostol
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Claudication Distance Assessment
Time Frame: Change from baseline, after they have been treated with Misoprostol
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Measure walking tolerance to determine the severity of their lumbar spinal stenosis symptoms.
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Change from baseline, after they have been treated with Misoprostol
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Pathological Conditions, Anatomical
- Spinal Diseases
- Bone Diseases
- Back Pain
- Low Back Pain
- Constriction, Pathologic
- Spinal Stenosis
- Physiological Effects of Drugs
- Gastrointestinal Agents
- Reproductive Control Agents
- Anti-Ulcer Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Oxytocics
- Misoprostol
Other Study ID Numbers
- 19-006
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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