Misoprostol for Spinal Stenosis

NCT04611464 | Completed FDA Drug

• 1 other identifier: 19-006
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Lumbar Spinal Stenosis; Low Back Pain

Outcome Measures

Primary Outcomes (3)

• Swiss Lumbar Spinal Stenosis Questionnaire(SSSQ)

  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

• Oswestry Disability Index (ODI)

  The ODI quantifies disability dues to lumbar spinal stenosis symptoms

  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.

  Change from baseline, after they have been treated with Misoprostol

Study Arms (1)

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.

Drug: Misoprostol

Interventions

Misoprostol DRUG

Misoprostol is a PGE1 analog

Single-group cross-sectional cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

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.

Sponsors & Collaborators

• Dallas VA Medical Center: lead

Study Sites (1)

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Location

MeSH Terms

Conditions

Spinal Stenosis; Low Back Pain

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PM&R, Principal Investigator, Staff Physician

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: November 2, 2020
• Study Start: July 11, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: November 2, 2020

Record last verified: 2020-10

Locations

US (1)