Lumbar Spine Degenerative Changes, Lumbar Spine Surgery
Conditions
Keywords
behavioral research, Patient Reported Outcomes Measures, Pain, Pain Catastrophizing
Brief 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 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.
Interventions
BEHAVIORALEmpowered 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.
OTHEREducation
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.
Sponsors
Vanderbilt University Medical Center
United States Department of Defense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Surgical treatment of a lumbar degenerative condition using a laminectomy and/or 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Interference | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Function | 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 |
| Disability | 3 and 6 months after hospital discharge | Oswestry Disability Index (0-100%), higher percentages indicate greater impairment |
| Pain Intensity | 3 and 6 months after hospital discharge | Numeric Rating Scale for back pain and leg pain (0-10), higher scores indicate greater pain intensity |
| Opioid Use | 3 and 6 months after hospital discharge | morphine milligram equivalents |
Countries
United States
Contacts
CONTACTKristin Archer, PhD
CONTACTAmanda Priest
Outcome results
None listed