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Completed

NCT Number: NCT04207606

Post Epidural Steroid Injection Follow-up

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.

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Key information

Conditions

Lumbago Back Pain Bone Diseases Hernia Intervertebral Disc Displacement Low Back Pain Lumbar Disc Herniation Lumbar Spinal Stenosis Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Diseases Spinal Stenosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stallworth Rehabilitation Hospital

Nashville, Tennessee, 37212, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Post Epidural Steroid Injection Follow-up

Behavioral

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.

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

Secondary outcomes

  1. Global Rating of Change

    Time frame: Every 3 days for up to 23 days

    Measures reduction in pain intensity. Range: 0 to 100%, with 0% representing no change in pain and 100% representing complete relief of index pain.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

Follow-up of Pain Intensity Post Epidural Steroid Injection

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 23, 2019
Registry last updated
Mar 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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