A Study Of Epidural Steroid Injection For Lumbar Spinal Stenosis With Neurogenic Claudication
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 26-002320
About this study
The purpose of this study is to evaluate the effectiveness of ESIs in improving 1) self-report pain, function and quality of life; and 2) performance. Secondarily, an exploratory analysis of the pre-injection data will be performed to determine if there are consistent factors that predict therapeutic success to ESI that may help inform future clinical recommendations. Additionally, discrepancies between PRO and performance outcomes will be explored to inform future research.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
Patients between the ages of 45 and 85 with at least moderate degenerative central spinal canal stenosis on MRI or CT and a positive screen for non-radicular lumbar spinal stenosis on a self-administered, self-reported history questionnaire (SSHQ) [40, 41] who will be undergoing ESI in the division of Pain Medicine, own an iPhone, are willing to wear a device for a minimum of 56 hrs/week for each of three 15 day periods of data collection, and do not have another diagnosis that better explains their symptoms including vascular claudication.
Exclusion Criteria:
Patients will be excluded if they have had prior lumbar spine surgery, have had an epidural steroid injection within the last 3 months, do not have an iPhone compatible with the Apple Watch, are currently incarcerated, are non-English speaking, are unable to understand or operate the device or have any comorbid condition that significantly limits walking such as severe cardiopulmonary disease, prior stroke or pregnancy. Furthermore, patients who have a current diagnosis of cancer that is believed to be contributing to their spine pain will be excluded.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 04/20/2026. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Paul Scholten, M.D. |
Contact us for the latest status |
|
More information
Publications
Publications are currently not available