Lumbar Spine Degenerative ChangesRESTORENCT07406997
Rehabilitation With Empowered STrategies to Optimize REcovery
A study testing Empowered Relief and Education in people with Lumbar Spine Degenerative Changes and Lumbar Spine Surgery, run by Vanderbilt University Medical Center at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lumbar Spine Degenerative Changes, Lumbar Spine Surgery
- What is being tested?
- Empowered Relief and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesUnited States
- Study dates
- 24 Feb 2026to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgical treatment of a lumbar degenerative condition using a laminectomy and/or fusion procedure
- English speaking
- Age between 18-85 years
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Not yet recruiting
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
Rachel Mayhew, DPT, 253-987-2911, rmayhew@genevausa.org
Daniel Rhon, PhD
- Not yet recruiting
Tripler Army Medical Center
Honolulu, Hawaii, 96859
Rachel Mayhew, DPT, 253-987-2911, rmayhew@genevausa.org
Daniel Rhon, PhD
- Not yet recruiting
Madigan Army Medical Center
Joint Base Lewis McChord, Washington, 98431
Rachel Mayhew, DPT, 253-987-2911, rmayhew@genevausa.org
Daniel Rhon, PhD
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
Amanda Priest, 615-421-8336, amanda.priest@vumc.org
Kristin Archer, PhD
About this study
Official title: 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?
Read more
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
Read the 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.
- Being tested
- Empowered Relief, Education
- Keywords
- behavioral research, Patient Reported Outcomes Measures, Pain, Pain Catastrophizing
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowered ReliefBehavioural
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.
EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Empowered Relief | Experimental | Remotely delivered group session with behavioral strategies Receives: Behavioral: Empowered Relief |
| Education | Active comparator | Remotely delivered group session with educational information Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Interference
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (T-score metric), higher scores indicate greater pain interference
Measured: 3 and 6 months after hospital discharge
Secondary outcomes (4)
Physical Function
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (T-score metric), higher scores indicate better physical function
Measured: 3 and 6 months after hospital discharge
Disability
Oswestry Disability Index (0-100%), higher percentages indicate greater impairment
Measured: 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
Measured: 3 and 6 months after hospital discharge
Opioid Use
morphine milligram equivalents
Measured: 3 and 6 months after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start24 Feb 2026
- Primary completion28 Feb 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spine Degenerative ChangesStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Kristin Archer, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406997
- Sponsor's protocol ID
- 251516
- Other IDs
- HT9425-25-1-0925
- Acronym
- RESTORE
- Status last verified
- Mar 2026
- First submitted
- 5 Feb 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation With Empowered STrategies to Optimize REcovery After Spine Surgery
- ClinicalTrials.gov ID
- NCT07406997
- Acronym / sponsor ID
- RESTORE / 251516
- Keywords
- behavioral research, Patient Reported Outcomes Measures, Pain, Pain Catastrophizing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empowered Relief | Experimental | Behavioral: Empowered ReliefRemotely delivered group session with behavioral strategies |
| Education | Active comparator | Other: EducationRemotely delivered group session with educational information |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Surgical treatment of a lumbar degenerative condition using a laminectomy and/or fusion procedure
- English speaking
- Age between 18-85 years
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empowered ReliefEmpowered 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. | Behavioural | Empowered Relief |
| EducationEducation 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. | Other | Education |
Primary outcome
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
4 secondary outcomes
Physical Function
Time frame: 3 and 6 months after hospital discharge
Disability
Time frame: 3 and 6 months after hospital discharge
Pain Intensity
Time frame: 3 and 6 months after hospital discharge
Opioid Use
Time frame: 3 and 6 months after hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empowered Relief and Education in people with Lumbar Spine Degenerative Changes and Lumbar Spine Surgery, run by Vanderbilt University Medical Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristin Archer, PhD (615-322-2732, kristin.archer@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Interference (time frame: 3 and 6 months after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.