Recruiting

Empowered Relief

Sponsor:

Vanderbilt University Medical Center

Code:

NCT07406997

Conditions

Lumbar Spine Degenerative Changes

Lumbar Spine Surgery

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Empowered Relief

Education

Study Details

Brief summary:

The main goal of this clinical trial is to understand the benefits of remotely delivered Empowered Relief in patients undergoing lumbar spine surgery. The main question the trial aims to answer is:

Does a postoperative behavioral intervention, Empowered Relief, performed early after back surgery have a measurable impact on postoperative outcomes?

Additional questions are whether changes in pain catastrophizing are related to improvements in outcomes and whether preoperative pain catastrophizing is a moderator of response to treatment.

Researchers will compare remotely delivered Empowered Relief to remotely delivered education to see if Empowered Relief helps patients manage their pain and functional limitations after back surgery.

Participants will:

  • Complete one group session of remotely delivered Empowered Relief or Education after back surgery
  • Complete surveys before surgery and 3- and 6-months after surgery

Conditions

Lumbar Spine Degenerative Changes

Lumbar Spine Surgery

Study ID

NCT07406997

Start date

Feb 24, 2026

Status verified date

Mar, 2026

Completion date

Aug 31, 2029

Anticipated

Primary completion date

Feb 28, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Surgical treatment of a lumbar degenerative condition using a laminectomy and/or fusion procedure
  • English speaking
  • Age between 18-85 years

Exclusion Criteria:

  • Surgery due to trauma, fracture, tumor, infection, or spinal deformity
  • Revision surgery
  • Prior history of lumbar spine surgery in last 12 months
  • Involved in litigation or a workers' compensation claim due to injury
  • Currently undergoing treatment for cancer
  • Unable to access a reliable internet connection
  • Unable to provide a stable telephone or physical address
  • Unable to participate in follow-up assessment for 6 months after surgery

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Empowered Relief

Remotely delivered group session with behavioral strategies

active comparator: Education

Remotely delivered group session with educational information

Interventions

Empowered Relief

Empowered Relief (ER) is a single-session group class that has two main components of pain neuroscience education and pain coping skills based on cognitive-behavioral principles.

Education

Education program is a single-session group class that includes information on how to manage pain and disability, prevent future injury and stay healthy after back surgery.

Primary outcome measure

  • Pain Interference [ Time Frame: 3 and 6 months after hospital discharge ]

Central Contacts and Locations

Central contacts

Kristin Archer, PhD

615-322-2732kristin.archer@vumc.org

Amanda Priest

615-421-8336amanda.priest@vumc.org

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Amanda Priest

615-421-8336amanda.priest@vumc.org

Principal Investigator:

Kristin Archer, PhD

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Aug 20, 2026

Last verified

Mar, 2026

Keywords

  • behavioral research
  • Patient Reported Outcomes Measures
  • Pain
  • Pain Catastrophizing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-08-20.