Lumbar Spinal StenosisNCT04611464
Misoprostol for Spinal Stenosis
An observational study of Lumbar Spinal Stenosis and Low Back Pain, run by Dallas VA Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis, Low Back Pain
- What is being tested?
- Misoprostol
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2019to 1 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain and Functional Outcomes With Misoprostol Treatment for Lumbar Spinal Stenosis
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.
Read the 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.
- Conditions
- Lumbar Spinal Stenosis, Low Back Pain
- Being tested
- Misoprostol
- Medical subject headings
- Spinal Stenosis, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Misoprostol is a PGE1 analog
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swiss Lumbar Spinal Stenosis Questionnaire(SSSQ)
The SSSQ quantifies severity of symptoms, physical function characteristics, and patient's satisfaction after treatment.
Measured: Once at baseline, after they have been treated with Misoprostol; SSSQ has not been collected previously
Oswestry Disability Index (ODI)
The ODI quantifies disability dues to lumbar spinal stenosis symptoms
Measured: Change from baseline, after they have been treated with Misoprostol
Claudication Distance Assessment
Measure walking tolerance to determine the severity of their lumbar spinal stenosis symptoms.
Measured: Change from baseline, after they have been treated with Misoprostol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start11 Jul 2019
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dallas VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Thiru Annaswamy, Dallas VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611464
- Sponsor's protocol ID
- 19-006
- Status last verified
- Oct 2020
- First submitted
- 9 Oct 2020
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain and Functional Outcomes With Misoprostol Treatment for Lumbar Spinal Stenosis
- ClinicalTrials.gov ID
- NCT04611464
- Acronym / sponsor ID
- 19-006
- Conditions
- Lumbar Spinal Stenosis, Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Dallas VA Medical CenterUS federal agency
- Study start
- 11 Jul 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 2 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-group cross-sectional cohort | – | Drug: MisoprostolPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- 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:
- Must be able to read English and complete questionnaire.
- Was prescribed Misoprostol specifically for lumbar spinal stenosis.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MisoprostolMisoprostol is a PGE1 analog | Drug | Single-group cross-sectional cohort |
Primary outcome
Swiss Lumbar Spinal Stenosis Questionnaire(SSSQ)
Time frame: Once at baseline, after they have been treated with Misoprostol; SSSQ has not been collected previously
The SSSQ quantifies severity of symptoms, physical function characteristics, and patient's satisfaction after treatment.
Oswestry Disability Index (ODI)
Time frame: Change from baseline, after they have been treated with Misoprostol
The ODI quantifies disability dues to lumbar spinal stenosis symptoms
Claudication Distance Assessment
Time frame: Change from baseline, after they have been treated with Misoprostol
Measure walking tolerance to determine the severity of their lumbar spinal stenosis symptoms.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spinal Stenosis and Low Back Pain, run by Dallas VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swiss Lumbar Spinal Stenosis Questionnaire(SSSQ) (time frame: Once at baseline, after they have been treated with Misoprostol; SSSQ has not been collected previously). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2020; AzTrials last refreshed its copy on 4 Nov 2026.