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NCT Number: NCT07406997

Rehabilitation With Empowered STrategies to Optimize REcovery

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

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Key information

Conditions

Lumbar Spine Degenerative Changes Lumbar Spine Surgery Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tripler Army Medical Center, Honolulu, Hawaii, United States

Loading trial locations.

About this study

The proposed study will conduct a phase II, two-group randomized controlled trial in patients undergoing lumbar spine surgery. Patients will be enrolled and randomized prior to spine surgery from a civilian medical center and military treatment facilities. Patients will be randomized to either (1) 1-session Empowered Relief or (2) 1-session Education. Both interventions are delivered remotely in a group setting through a web-based platform by licensed health care professionals. Outcome assessments will be conducted by evaluators blinded to group assignment at 3-months and 6-months after surgery.The results of our clinical trial will advance research on remote nonpharmacologic strategies for managing pain and improving quality of life post-surgery in both civilian and military patient populations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Surgical treatment of a lumbar degenerative condition using a laminectomy with or without 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

Treatment and study plan

Empowered Relief

Behavioral

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

Other

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 outcomes

  1. Pain Interference

    Time frame: 3 and 6 months after hospital discharge

    Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (T-score metric), higher scores indicate greater pain interference

Secondary outcomes

  1. Physical Function

    Time frame: 3 and 6 months after hospital discharge

    Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (T-score metric), higher scores indicate better physical function

  2. Disability

    Time frame: 3 and 6 months after hospital discharge

    Oswestry Disability Index (0-100%), higher percentages indicate greater impairment

  3. Pain Intensity

    Time frame: 3 and 6 months after hospital discharge

    Numeric Rating Scale for back pain and leg pain (0-10), higher scores indicate greater pain intensity

  4. Opioid Use

    Time frame: 3 and 6 months after hospital discharge

    morphine milligram equivalents

Other outcomes

  1. Pain Catastrophizing

    Time frame: 3 and 6 months after hospital discharge

    Pain Catastrophizing Scale (0-51), higher scores indicate higher levels of pain-related, catastrophic thinking

  2. Sleep

    Time frame: 3 and 6 months after hospital discharge

    Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (T-score metric), higher scores indicate more severe sleep disturbance

  3. Patient Satisfaction

    Time frame: 3 and 6 months after hospital discharge

    NASS Patient Satisfaction Index (4-point scale), higher scores indicate being less satisfied

  4. Employment

    Time frame: 3 and 6 months after hospital discharge

    Return to work or duty (yes or no) and date of return

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda Priest

CONTACT

[email protected]

615-421-8336

Kristin Archer, PhD

CONTACT

[email protected]

615-322-2732

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

Rehabilitation With Empowered STrategies to Optimize REcovery After Spine Surgery

Acronym: RESTORE

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Feb 12, 2026
Registry last updated
Jun 1, 2026

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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