Rehabilitation With Empowered STrategies to Optimize REcovery (RESTORE)

May 27, 2026 updated by: Kristin Archer, Vanderbilt University Medical Center

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Hawaii
      • Honolulu, Hawaii, United States, 96859
        • Not yet recruiting
        • Tripler Army Medical Center
        • Principal Investigator:
          • Daniel Rhon, PhD
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
        • 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:
    • Washington
      • Joint Base Lewis McChord, Washington, United States, 98431
        • Not yet recruiting
        • Madigan Army Medical Center
        • Principal Investigator:
          • Daniel Rhon, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
3 and 6 months after hospital discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Opioid Use
Time Frame: 3 and 6 months after hospital discharge
morphine milligram equivalents
3 and 6 months after hospital discharge
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
3 and 6 months after hospital discharge
Disability
Time Frame: 3 and 6 months after hospital discharge
Oswestry Disability Index (0-100%), higher percentages indicate greater impairment
3 and 6 months after hospital discharge
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
3 and 6 months after hospital discharge

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
3 and 6 months after hospital discharge
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 and 6 months after hospital discharge
Patient Satisfaction
Time Frame: 3 and 6 months after hospital discharge
NASS Patient Satisfaction Index (4-point scale), higher scores indicate being less satisfied
3 and 6 months after hospital discharge
Employment
Time Frame: 3 and 6 months after hospital discharge
Return to work or duty (yes or no) and date of return
3 and 6 months after hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vanderbilt University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
United States Department of Defense

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 24, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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