NCT04207606

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 23, 2019

Completed
11 days until next milestone

Study Start

First participant enrolled

January 3, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 12, 2021

Status Verified

March 1, 2021

Enrollment Period

11 months

First QC Date

December 10, 2019

Last Update Submit

March 11, 2021

Conditions

LumbagoLumbar Spinal StenosisLumbar Disc Herniation

Keywords

epidural steroidlumbar back painPharmacokineticsTimelineNatural History

Outcome Measures

Primary Outcomes (8)

  • 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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    post-procedure day 22 (+/- 1 day)

Secondary Outcomes (1)

  • Global Rating of Change

    Every 3 days for up to 23 days

Study Arms (1)

Epidural Steroid Injection Patients

Patients who are to receive an epidural steroid injection as an outpatient.

Behavioral: Post Epidural Steroid Injection Follow-up

Interventions

Post Epidural Steroid Injection Follow-upBEHAVIORAL

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.

Epidural Steroid Injection Patients

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients with low back pain who are to undergo Epidural Steroid Injection for pain relief.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stallworth Rehabilitation Hospital

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Low Back PainSpinal StenosisIntervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, Anatomical

Study Officials

  • Byron J Schneider, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 10, 2019

First Posted

December 23, 2019

Study Start

January 3, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

March 12, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)