LumbagoNCT04207606
Post Epidural Steroid Injection Follow-up
An observational study of Lumbago and Lumbar Spinal Stenosis, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
To determine the expected pain response timeline for patients receiving epidural steroid injections, our team plans to assess patient pain severity and degree of pain relief every 3 days for 23 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbago, Lumbar Spinal Stenosis, Lumbar Disc Herniation
- What is being tested?
- Post Epidural Steroid Injection Follow-up
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2020to 1 Dec 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
- Adult, Older adult
Study population: Adult patients with low back pain who are to undergo Epidural Steroid Injection for pain relief.
Who may be able to join
- Any patient schedule for an epidural steroid injection (ESI) at Stallworth Rehabilitation Hospital through the department of Physical Medicine \& Rehabilitation.
- The epidural steroid injection will be performed as part of standard clinical care, this study only aims to describe the clinical response to the procedure.
Who cannot join
- ESI has been performed within the last 6 months
- Steroid injection elsewhere in body within last 8 weeks
- Oral or intramuscular steroids within last 8 weeks
- Unwilling or unable to provide informed consent
- Unable to comply with required follow up
- Please note that it is assumed that a patient scheduled for an epidural steroid injection clinically is assumed to not have any contraindications to the injection itself such as active systemic infection or pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stallworth Rehabilitation Hospital
Nashville, Tennessee, 37212
About this study
Official title: Follow-up of Pain Intensity Post Epidural Steroid Injection
To determine the expected pain response timeline for patients receiving epidural steroid injections, our team plans to assess patient pain severity and degree of pain relief every 3 days for 23 days.
Read the detailed description
Patients who are already planning to receive an epidural steroid injection from their physiatrist will be approached by study members on the day of their injection. If enrolled, the patients will be contacted every 3 days for 23 days to determine the severity of pain and degree of pain relief from the injection.
- Conditions
- Lumbago, Lumbar Spinal Stenosis, Lumbar Disc Herniation
- Being tested
- Post Epidural Steroid Injection Follow-up
- Keywords
- epidural steroid, lumbar back pain, Pharmacokinetics, Timeline, Natural History
- Medical subject headings
- Low Back Pain, Spinal Stenosis, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post Epidural Steroid Injection Follow-upBehavioural
All enrolled patients will undergo epidural steroid injection with fluoroscopy per the Spine Intervention Society guidelines as part of their normal care. Patients will then be contacted for survey responses every 3 days for a maximum of 23 days, to assess pain intensity and change.
| Study group | Role | What they receive |
|---|---|---|
| Epidural Steroid Injection Patients | Patients who are to receive an epidural steroid injection as an outpatient. Receives: Behavioral: Post Epidural Steroid Injection Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Numeric Pain Rating Scale (NPRS)
The NPRS measures pain intensity. Range 0 to 10, with 0 representing "no pain" and 10 representing the worst possible pain. This metric outcome will be the numerical difference between the pre-procedure NPRS score and the NPRS score as measured on post-procedure day 1 (+ 1 day)
Measured: post-procedure day 1 (+1 day)
Change in Numeric Pain Rating Scale (NPRS)
The NPRS measures pain intensity. Range 0 to 10, with 0 representing "no pain" and 10 representing the worst possible pain. This metric outcome will be the numerical difference between the pre-procedure NPRS score and the NPRS score as measured on post-procedure day 4 (+/- 1 day)
Measured: post-procedure day 4 (+/- 1 day)
Change in Numeric Pain Rating Scale (NPRS)
The NPRS measures pain intensity. Range 0 to 10, with 0 representing "no pain" and 10 representing the worst possible pain. This metric outcome will be the numerical difference between the pre-procedure NPRS score and the NPRS score as measured on post-procedure day 7 (+/- 1 day)
Measured: post-procedure day 7 (+/- 1 day)
Change in Numeric Pain Rating Scale (NPRS)
The NPRS measures pain intensity. Range 0 to 10, with 0 representing "no pain" and 10 representing the worst possible pain. This metric outcome will be the numerical difference between the pre-procedure NPRS score and the NPRS score as measured on post-procedure day 10 (+/- 1 day)
Measured: post-procedure day 10 (+/- 1 day)
Change in Numeric Pain Rating Scale (NPRS)
The NPRS measures pain intensity. Range 0 to 10, with 0 representing "no pain" and 10 representing the worst possible pain. This metric outcome will be the numerical difference between the pre-procedure NPRS score and the NPRS score as measured on post-procedure day 13 (+/- 1 day)
Measured: post-procedure day 13 (+/- 1 day)
Change in Numeric Pain Rating Scale (NPRS)
The NPRS measures pain intensity. Range 0 to 10, with 0 representing "no pain" and 10 representing the worst possible pain. This metric outcome will be the numerical difference between the pre-procedure NPRS score and the NPRS score as measured on post-procedure day 16 (+/- 1 day)
Measured: post-procedure day 16 (+/- 1 day)
Change in Numeric Pain Rating Scale (NPRS)
The NPRS measures pain intensity. Range 0 to 10, with 0 representing "no pain" and 10 representing the worst possible pain. This metric outcome will be the numerical difference between the pre-procedure NPRS score and the NPRS score as measured on post-procedure day 19 (+/- 1 day)
Measured: post-procedure day 19 (+/- 1 day)
Change in Numeric Pain Rating Scale (NPRS)
The NPRS measures pain intensity. Range 0 to 10, with 0 representing "no pain" and 10 representing the worst possible pain. This metric outcome will be the numerical difference between the pre-procedure NPRS score and the NPRS score as measured on post-procedure day 22 (+/- 1 day)
Measured: post-procedure day 22 (+/- 1 day)
Secondary outcomes (1)
Global Rating of Change
Measures reduction in pain intensity. Range: 0 to 100%, with 0% representing no change in pain and 100% representing complete relief of index pain.
Measured: Every 3 days for up to 23 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start3 Jan 2020
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LumbagoStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Byron Schneider, Vanderbilt University Medical Center
- Investigators
- Byron J Schneider, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207606
- Sponsor's protocol ID
- 11192019110246
- Status last verified
- Mar 2021
- First submitted
- 10 Dec 2019
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Pain Intensity Post Epidural Steroid Injection
- ClinicalTrials.gov ID
- NCT04207606
- Acronym / sponsor ID
- 11192019110246
- Conditions
- Lumbago, Lumbar Spinal Stenosis, Lumbar Disc Herniation
- Keywords
- epidural steroid, lumbar back pain, Pharmacokinetics, Timeline, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 23 Dec 2019 (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.
To determine the expected pain response timeline for patients receiving epidural steroid injections, our team plans to assess patient pain severity and degree of pain relief every 3 days for 23 days.
Detailed description
Patients who are already planning to receive an epidural steroid injection from their physiatrist will be approached by study members on the day of their injection. If enrolled, the patients will be contacted every 3 days for 23 days to determine the severity of pain and degree of pain relief from the injection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epidural Steroid Injection Patients | – | Behavioral: Post Epidural Steroid Injection Follow-upPatients who are to receive an epidural steroid injection as an outpatient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients with low back pain who are to undergo Epidural Steroid Injection for pain relief.
Key inclusion criteria (2 listed)
- Any patient schedule for an epidural steroid injection (ESI) at Stallworth Rehabilitation Hospital through the department of Physical Medicine \& Rehabilitation.
- The epidural steroid injection will be performed as part of standard clinical care, this study only aims to describe the clinical response to the procedure.
Key exclusion criteria (6 listed)
- ESI has been performed within the last 6 months
- Steroid injection elsewhere in body within last 8 weeks
- Oral or intramuscular steroids within last 8 weeks
- Unwilling or unable to provide informed consent
- Unable to comply with required follow up
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 |
|---|---|---|
| Post Epidural Steroid Injection Follow-upAll enrolled patients will undergo epidural steroid injection with fluoroscopy per the Spine Intervention Society guidelines as part of their normal care. Patients will then be contacted for survey responses every 3 days for a maximum of 23 days, to assess pain intensity and change. | Behavioural | Epidural Steroid Injection Patients |
Primary outcome
Change in Numeric Pain Rating Scale (NPRS)
Time frame: post-procedure day 1 (+1 day)
The NPRS measures pain intensity. Range 0 to 10, with 0 representing "no pain" and 10 representing the worst possible pain. This metric outcome will be the numerical difference between the pre-procedure NPRS score and the NPRS score as measured on post-procedure day 1 (+ 1 day)
Change in Numeric Pain Rating Scale (NPRS)
Time frame: post-procedure day 4 (+/- 1 day)
The NPRS measures pain intensity. Range 0 to 10, with 0 representing "no pain" and 10 representing the worst possible pain. This metric outcome will be the numerical difference between the pre-procedure NPRS score and the NPRS score as measured on post-procedure day 4 (+/- 1 day)
Change in Numeric Pain Rating Scale (NPRS)
Time frame: post-procedure day 7 (+/- 1 day)
The NPRS measures pain intensity. Range 0 to 10, with 0 representing "no pain" and 10 representing the worst possible pain. This metric outcome will be the numerical difference between the pre-procedure NPRS score and the NPRS score as measured on post-procedure day 7 (+/- 1 day)
Change in Numeric Pain Rating Scale (NPRS)
Time frame: post-procedure day 10 (+/- 1 day)
The NPRS measures pain intensity. Range 0 to 10, with 0 representing "no pain" and 10 representing the worst possible pain. This metric outcome will be the numerical difference between the pre-procedure NPRS score and the NPRS score as measured on post-procedure day 10 (+/- 1 day)
Change in Numeric Pain Rating Scale (NPRS)
Time frame: post-procedure day 13 (+/- 1 day)
The NPRS measures pain intensity. Range 0 to 10, with 0 representing "no pain" and 10 representing the worst possible pain. This metric outcome will be the numerical difference between the pre-procedure NPRS score and the NPRS score as measured on post-procedure day 13 (+/- 1 day)
Change in Numeric Pain Rating Scale (NPRS)
Time frame: post-procedure day 16 (+/- 1 day)
The NPRS measures pain intensity. Range 0 to 10, with 0 representing "no pain" and 10 representing the worst possible pain. This metric outcome will be the numerical difference between the pre-procedure NPRS score and the NPRS score as measured on post-procedure day 16 (+/- 1 day)
Change in Numeric Pain Rating Scale (NPRS)
Time frame: post-procedure day 19 (+/- 1 day)
The NPRS measures pain intensity. Range 0 to 10, with 0 representing "no pain" and 10 representing the worst possible pain. This metric outcome will be the numerical difference between the pre-procedure NPRS score and the NPRS score as measured on post-procedure day 19 (+/- 1 day)
Change in Numeric Pain Rating Scale (NPRS)
Time frame: post-procedure day 22 (+/- 1 day)
The NPRS measures pain intensity. Range 0 to 10, with 0 representing "no pain" and 10 representing the worst possible pain. This metric outcome will be the numerical difference between the pre-procedure NPRS score and the NPRS score as measured on post-procedure day 22 (+/- 1 day)
1 secondary outcome
Global Rating of Change
Time frame: Every 3 days for up to 23 days
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 12 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Lumbago
RecruitingPhase 3
Anesthetic Block of the Erector Muscles of the Lumbar Spine to Relieve Acute Lumbar Pain: Pilot Study
Lumbago
Not yet recruitingObservational study
Treatment of Mechanical Low Back Pain With High-Intensity Focused Ultrasound (HIFU)
Lumbago
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.
Byron J Schneider, MD principal investigator
Vanderbilt University Medical Center
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 Lumbago and Lumbar Spinal Stenosis, run by Vanderbilt University 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 2 inclusion and 6 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 12 Mar 2021. 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?
Change in Numeric Pain Rating Scale (NPRS) (time frame: post-procedure day 1 (+1 day)). The study lists 8 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 12 Mar 2021; AzTrials last refreshed its copy on 29 Oct 2026.