Rehabilitation With Empowered STrategies to Optimize REcovery

Part of paid clinical trials in Honolulu, Hawaii.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT07406997
Status
Recruiting
Apply to this trial

Conditions

  • Lumbar Spine Degenerative Changes
  • Lumbar Spine Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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

Key Dates

Start date
Feb 24, 2026
Status verified
Mar 2026
Primary completion
Feb 28, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Empowered Relief
    Remotely delivered group session with behavioral strategies
  • Active Comparator: Education
    Remotely delivered group session with educational information

Primary Outcome Measure

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

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Tripler Army Medical CenterHonoluluHawaii96859
Rachel Mayhew, DPT
[email protected]
253-987-2911
Daniel Rhon, PhD (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37203
Amanda Priest
[email protected]
615-421-8336
Kristin Archer, PhD (PRINCIPAL_INVESTIGATOR)
Brooke Army Medical CenterFort Sam HoustonTexas78234
Rachel Mayhew, DPT
[email protected]
253-987-2911
Daniel Rhon, PhD (PRINCIPAL_INVESTIGATOR)
Madigan Army Medical CenterJoint Base Lewis McChordWashington98431
Rachel Mayhew, DPT
[email protected]
253-987-2911
Daniel Rhon, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Honolulu, HI

By research site
Tripler Army Medical Center· Honolulu, HIVanderbilt University Medical Center· Nashville, TNBrooke Army Medical Center· Fort Sam Houston, TXMadigan Army Medical Center· Joint Base Lewis McChord, WA

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