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| ID | Type | Description | Link |
|---|---|---|---|
| HT9425-25-1-0925 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empowered Relief | Experimental | Remotely delivered group session with behavioral strategies |
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| Education | Active Comparator | Remotely delivered group session with educational information |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Interference | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Function | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Catastrophizing | Pain Catastrophizing Scale (0-51), higher scores indicate higher levels of pain-related, catastrophic thinking | 3 and 6 months after hospital discharge |
| Sleep | Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (T-score metric), higher scores indicate more severe sleep disturbance |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristin Archer, PhD | Contact | 615-322-2732 | kristin.archer@vumc.org | |
| Amanda Priest | Contact | 615-421-8336 | amanda.priest@vumc.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tripler Army Medical Center | Not yet recruiting | Honolulu | Hawaii | 96859 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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| 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. |
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Oswestry Disability Index (0-100%), higher percentages indicate greater impairment
| 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 | 3 and 6 months after hospital discharge |
| Opioid Use | morphine milligram equivalents | 3 and 6 months after hospital discharge |
| 3 and 6 months after hospital discharge |
| Patient Satisfaction | NASS Patient Satisfaction Index (4-point scale), higher scores indicate being less satisfied | 3 and 6 months after hospital discharge |
| Employment | Return to work or duty (yes or no) and date of return | 3 and 6 months after hospital discharge |
| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37203 | United States |
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| Brooke Army Medical Center | Not yet recruiting | Fort Sam Houston | Texas | 78234 | United States |
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| Madigan Army Medical Center | Not yet recruiting | Joint Base Lewis McChord | Washington | 98431 | United States |
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