Rehabilitation With Empowered STrategies to Optimize REcovery (RESTORE)

Vanderbilt University Medical Center

Status: Enrolling

Conditions: Lumbar Spine Surgery; Lumbar Spine Degenerative Changes

Treatments: Other: Education; Behavioral: Empowered Relief

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT07406997

HT9425-25-1-0925 (Other Grant/Funding Number)

251516

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Surgical treatment of a lumbar degenerative condition using a laminectomy with or without fusion procedure
• English speaking
• Age between 18-75 years

Exclusion criteria

• Surgery due to trauma, fracture, tumor, infection, or spinal deformity
• Revision surgery
• Prior history of lumbar spine surgery in last 5 years
• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Empowered Relief

Experimental group

Description:

Remotely delivered group session with behavioral strategies

Treatment:

Behavioral: Empowered Relief

Education

Active Comparator group

Description:

Remotely delivered group session with educational information

Treatment:

Other: Education