Rehabilitation With Empowered STrategies to Optimize REcovery (RESTORE)

Rehabilitation With Empowered STrategies to Optimize REcovery After Spine Surgery

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

Study Overview

• Status: Recruiting
• Conditions: Lumbar Spine Degenerative Changes; Lumbar Spine Surgery
• Intervention / Treatment: Behavioral: Empowered Relief; Other: Education

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amanda Priest; Phone Number: 615-421-8336; Email: amanda.priest@vumc.org
• Study Contact Backup: Name: Kristin Archer, PhD; Phone Number: 615-322-2732; Email: kristin.archer@vumc.org

Study Locations

• United States
  • Hawaii
    • Honolulu, Hawaii, United States, 96859
      • Not yet recruiting
      • Tripler Army Medical Center
      • Principal Investigator: Daniel Rhon, PhD
      • Contact: Rachel Mayhew, DPT; Phone Number: 253-987-2911; Email: rmayhew@genevausa.org
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Vanderbilt University Medical Center
      • Contact: Amanda Priest; Phone Number: 615-421-8336; Email: amanda.priest@vumc.org
      • Principal Investigator: Kristin Archer, PhD
  • Texas
    • Fort Sam Houston, Texas, United States, 78234
      • Not yet recruiting
      • Brooke Army Medical Center
      • Principal Investigator: Daniel Rhon, PhD
      • Contact: Rachel Mayhew, DPT; Phone Number: 253-987-2911; Email: rmayhew@genevausa.org
  • Washington
    • Joint Base Lewis McChord, Washington, United States, 98431
      • Not yet recruiting
      • Madigan Army Medical Center
      • Principal Investigator: Daniel Rhon, PhD
      • Contact: Rachel Mayhew, DPT; Phone Number: 253-987-2911; Email: rmayhew@genevausa.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Empowered Relief; Remotely delivered group session with behavioral strategies	Behavioral: 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.
Active Comparator: Education; Remotely delivered group session with educational information	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Interference	Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (T-score metric), higher scores indicate greater pain interference	3 and 6 months after hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Use	morphine milligram equivalents	3 and 6 months after hospital discharge
Physical Function	Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (T-score metric), higher scores indicate better physical function	3 and 6 months after hospital discharge
Disability	Oswestry Disability Index (0-100%), higher percentages indicate greater impairment	3 and 6 months after hospital discharge
Pain Intensity	Numeric Rating Scale for back pain and leg pain (0-10), higher scores indicate greater pain intensity	3 and 6 months after hospital discharge

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Catastrophizing	Pain Catastrophizing Scale (0-51), higher scores indicate higher levels of pain-related, catastrophic thinking	3 and 6 months after hospital discharge
Sleep	Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (T-score metric), higher scores indicate more severe sleep disturbance	3 and 6 months after hospital discharge
Patient Satisfaction	NASS Patient Satisfaction Index (4-point scale), higher scores indicate being less satisfied	3 and 6 months after hospital discharge
Employment	Return to work or duty (yes or no) and date of return	3 and 6 months after hospital discharge

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: United States Department of Defense

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2026
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): August 31, 2029

Study Registration Dates

• First Submitted: February 5, 2026
• First Submitted That Met QC Criteria: February 5, 2026
• First Posted (Actual): February 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Pain; Pain Catastrophizing; behavioral research; Patient Reported Outcomes Measures
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Socioeconomic Factors; Population Characteristics; Educational Status
• Other Study ID Numbers: 251516; HT9425-25-1-0925 (Other Grant/Funding Number: Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No