Empowered Relief for Back Surgery

(RESTORE Trial)

Not yet recruiting at 3 trial locations
KA
AP
Overseen ByAmanda Priest
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Vanderbilt University Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Empowered Relief, a behavioral intervention, can improve recovery after lumbar spine surgery. Researchers aim to determine if this approach reduces pain and enhances daily function compared to standard educational sessions. Participants must have undergone surgery for a degenerative back condition, such as a laminectomy, which relieves pressure on the spinal cord. The trial seeks English-speaking individuals who have not had back surgery in the past five years and can access the internet for remote sessions. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance recovery methods for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Empowered Relief is safe for patients undergoing back surgery?

Studies have shown that Empowered Relief is safe for patients. One study found that participants engaged well with the online Empowered Relief program and experienced significant pain reductions. Patients handled the treatment well and benefited from it. Another study showed that Empowered Relief reduced the need for pain medication after surgery and improved pain management. These results are promising, as they demonstrate positive patient responses without serious side effects.

Empowered Relief is similar to cognitive behavioral therapy, a well-known method for managing chronic pain, providing extra reassurance about its safety. Overall, evidence suggests that Empowered Relief is a well-tolerated way to manage pain after back surgery.12345

Why are researchers excited about this trial?

Researchers are excited about the Empowered Relief approach for back surgery patients because it offers a fresh perspective on managing pain. Unlike traditional treatments that often rely on medication or physical therapy, Empowered Relief focuses on remotely delivered behavioral strategies designed to help patients manage pain and stress effectively. This method provides patients with practical tools and strategies they can use independently, potentially reducing reliance on medications and enhancing recovery experiences. Additionally, the remote delivery aspect makes it accessible to more patients, allowing them to benefit from this support without needing to travel for in-person sessions.

What evidence suggests that Empowered Relief is effective for improving postoperative outcomes after back surgery?

Research has shown that Empowered Relief, one of the treatments in this trial, can help patients manage pain after surgery. In earlier studies, Empowered Relief reduced excessive worry about pain by an average of 28 points, with 90% of patients showing significant improvement. Other studies found that Empowered Relief also led to less need for opioids and reduced pain for up to three months after surgery. These findings suggest that Empowered Relief may aid recovery by teaching effective pain management skills. Another treatment arm in this trial involves an Education session, which provides participants with educational information.678910

Are You a Good Fit for This Trial?

This trial is for individuals with pancreatic cancer or lumbar spine degeneration who are undergoing lumbar spine surgery. Participants must be willing to complete a group session of Empowered Relief or Education after their surgery and fill out surveys before, as well as 3 and 6 months post-surgery.

Inclusion Criteria

English speaking
I had surgery for lower back pain involving removal of part of the bone or fusion.
I am between 18 and 75 years old.

Exclusion Criteria

I have had lumbar spine surgery within the last 5 years.
I am currently receiving cancer treatment.
Unable to access a reliable internet connection
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Assessment

Participants complete surveys before surgery to assess baseline pain and functional status

1 week

Treatment

Participants receive one group session of remotely delivered Empowered Relief or Education after back surgery

1 session

Follow-up

Participants are monitored for pain interference, physical function, disability, pain intensity, opioid use, pain catastrophizing, sleep disturbance, patient satisfaction, and employment status at 3 and 6 months after surgery

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Empowered Relief

Trial Overview

The study tests if a behavioral intervention called Empowered Relief can improve recovery when performed soon after back surgery, compared to standard education. It examines the effect on pain management and functional limitations through remote sessions.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Empowered ReliefExperimental Treatment1 Intervention
Group II: EducationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials
922
Recruited
939,000+

United States Department of Defense

Collaborator

Trials
940
Recruited
339,000+

Citations

Upskilling pain relief after surgery: a scoping review of ... - PMC

Empowered relief for surgery (formerly called My Surgical Success) is a self-paced, autonomous and interactive treatment that showed efficacy ...

Changes in Pain Catastrophizing and Related Outcomes ...

Pain catastrophizing scores reduced by an average of 28 points, with 90% achieving clinically significant change. Participation in Empowered ...

Transforming Standard of Care for Spine Surgery: Integration ...

The two trials of automated Empowered Relief provide promising early evidence for improving outcomes in different surgical populations.

Adopt Empowered Relief at your organization

Two surgical studies showed Empowered Relief significantly reduced opioid use after breast cancer surgery, and significantly reduced pain up to 3 months after ...

Efficacy of a Single-Session “Empowered Relief” Zoom- ...

The primary outcome was pain catastrophizing 1-month posttreatment, with pain intensity, pain bothersomeness, and sleep disruption as secondary ...

Transforming Standard of Care for Spine Surgery - PMC

Results revealed excellent patient engagement with online Empowered Relief, and clinically meaningful reductions in pain intensity, pain ...

Empowered Relief, cognitive behavioral therapy, and health ...

About 64.6% of the sample reported having low back pain for at least 5 years, and almost half of the sample (48%) reported having at least one ...

Upskilling pain relief after surgery: a scoping review of ...

One perioperative study demonstrated analgesic benefits and reduced opioid use 28 days after surgery (N=118); another (N=48) reported improved pain interference ...

(PDF) Empowered Relief, cognitive behavioral therapy ...

Outcome improvements within ER did not decrease significantly from 3-month to 6-month, and indeed ER showed additional 3- to 6-month ...

Comprehensive Approaches to Pain Management in ...

Effective postoperative pain management remains a major clinical challenge in spinal surgery, with poorly controlled pain affecting up to 50% of patients ...