272 Participants Needed

Non-pharmacological Pain Management for Post-Spine Surgery Pain

Recruiting at 3 trial locations
ML
Overseen ByMary Laugesen, DPT
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Dan Rhon
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications for this trial?

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 data supports the effectiveness of the Enriched Pain Management Pathway (EPM) treatment for managing pain after spine surgery?

Research suggests that a multidisciplinary approach, including non-drug methods like early mobilization and psychological support, can help manage pain after spine surgery. These components are part of enhanced recovery pathways, which have shown promise in improving postoperative outcomes.12345

Is non-pharmacological pain management for post-spine surgery pain safe?

The research suggests that non-pharmacological pain management techniques, such as those used in enhanced recovery pathways, are generally safe and can help reduce the need for opioids and their side effects after surgery. However, long-term safety data is still needed to fully understand their impact on persistent pain and opioid use.24678

How is the Enriched Pain Management Pathway treatment different from other treatments for post-spine surgery pain?

The Enriched Pain Management Pathway is unique because it focuses on non-drug methods like telephone counseling and nicotine replacement therapy, which are not typically part of standard care for post-spine surgery pain. This approach emphasizes a personalized, interdisciplinary plan that includes psychological support and patient education, aiming to reduce reliance on medications.2391011

What is the purpose of this trial?

This study will compare the effectiveness of two pain management pathways (standard vs. enriched) for patients undergoing lumbar spine surgery in the Military Health System (MHS). Effectiveness will be based on post-surgery patient-centered outcomes and extent of opioid use. The study design is a 2-arm, parallel group, individual-randomized trial.

Research Team

DI

Daniel Rhon, PhD

Principal Investigator

Brooke Army Medical Center

JM

Julie M Fritz, PhD

Principal Investigator

University of Utah

Eligibility Criteria

This trial is for Tricare beneficiaries aged 18-75 who need lumbar spine surgery due to conditions like herniated discs or scoliosis and can attend treatment sessions for 16 weeks post-surgery. It's not for those with pending medical discharges, previous lumbar surgeries within a year, or conditions that limit mobility.

Inclusion Criteria

I need surgery for a spine condition like herniated disc or scoliosis.
I can attend all treatment sessions for 16 weeks after surgery without taking a 2-week break.
I need surgery for a spine condition like herniated disc or scoliosis.
See 2 more

Exclusion Criteria

I need surgery urgently due to infection, fracture, tumor, trauma, or another emergency.
I do not have any health issues that prevent me from joining an exercise program after surgery.
I have had a lumbar surgery or a revision in the past year.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgery

Participants are randomized into two treatment groups prior to surgery

1 week

Post-operative Intervention

Participants receive either standard post-surgical care or enriched surgical management pathway with physical therapy and mindfulness

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including time to discontinuation of opioids and patient-reported outcomes

6 months

Treatment Details

Interventions

  • Enriched Pain Management Pathway (EPM)
  • Standard Care (SC)
Trial Overview The study compares two pain management methods after lumbar spine surgery: Standard Care (SC) versus an Enriched Pain Management Pathway (EPM). The goal is to see which one results in better patient outcomes and less opioid use. Participants are randomly assigned to one of the two groups.
Participant Groups
2Treatment groups
Active Control
Group I: Standard Care (SC)Active Control1 Intervention
Standard Post-Surgical Care utilizing opioids.
Group II: Enriched Surgical Management Pathway (EMP)Active Control1 Intervention
Enriched Surgical Management Pathway utilizing Physical Therapy and Mindfulness in addition to Standard Protocol.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dan Rhon

Lead Sponsor

Trials
2
Recruited
390+

59th Medical Wing

Collaborator

Trials
42
Recruited
12,700+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials
886
Recruited
677,000+

Brooke Army Medical Center

Collaborator

Trials
134
Recruited
28,100+

University of Utah

Collaborator

Trials
1,169
Recruited
1,623,000+

Madigan Army Medical Center

Collaborator

Trials
52
Recruited
17,600+

Tripler Army Medical Center

Collaborator

Trials
23
Recruited
27,900+

Findings from Research

Integrating the prescription drug monitoring program (PDMP) into the pain management workflow for elective surgery patients helps identify those on chronic opioid therapy before admission, allowing for personalized care.
This approach facilitates the development of tailored postoperative pain management plans and ensures a smooth transition back to outpatient care, enhancing patient safety and efficacy in pain management.
Using drug monitoring programs to optimize pain management for elective surgery patients.Lowry, R.[2018]
An interdisciplinary approach to perioperative pain management in spine surgery is essential, considering both pharmacologic and non-pharmacologic techniques, as well as psychological factors and patient education.
While various pain management strategies, including opioids, regional anesthetics, and behavioral interventions, have shown effectiveness in the short term, further long-term studies are necessary to assess their impact on chronic pain and opioid use after surgery.
Management of Postoperative Pain in Patients Following Spine Surgery: A Narrative Review.Prabhakar, NK., Chadwick, AL., Nwaneshiudu, C., et al.[2022]
This study aims to systematically review and synthesize evidence for 22 individual components of an enhanced recovery pathway for spinal surgery, focusing on factors like minimally invasive techniques, multimodal pain management, and early mobilization.
The review will evaluate critical outcomes such as mortality, morbidity, patient-reported experiences, and healthcare costs, ultimately aiming to standardize care and improve recovery for spinal surgery patients.
Proposed pathway for patients undergoing enhanced recovery after spinal surgery: protocol for a systematic review.Licina, A., Silvers, A., Laughlin, H., et al.[2023]

References

Using drug monitoring programs to optimize pain management for elective surgery patients. [2018]
Management of Postoperative Pain in Patients Following Spine Surgery: A Narrative Review. [2022]
Proposed pathway for patients undergoing enhanced recovery after spinal surgery: protocol for a systematic review. [2023]
Analysis of Fast-Track Surgery with Pain Care on Postoperative Pain Improvement and Complication Prevention in Perioperative Spine Surgery Patients. [2022]
The pivotal role for the multidisciplinary approach at all phases and at all levels in the national pathway for the management of low back pain and radicular pain in Belgium. [2020]
The IMpact of PerioperAtive KeTamine on Enhanced Recovery after Abdominal Surgery (IMPAKT ERAS): protocol for a pragmatic, randomized, double-blinded, placebo-controlled trial. [2023]
Effect of epidural analgesia on postoperative opioid requirements following elective laparotomies performed at Vancouver General Hospital. [2021]
The IMpact of PerioperAtive KeTamine on Enhanced Recovery after Abdominal Surgery (IMPAKT ERAS): protocol for a pragmatic, randomized, double-blinded, placebo-controlled trial. [2023]
Rapid recovery pathway without epidural catheter analgesia for surgical treatment of adolescent idiopathic scoliosis: a comparative study. [2023]
Efficacy of perioperative pharmacological and regional pain interventions in adult spine surgery: a network meta-analysis and systematic review of randomised controlled trials. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
The Evolution of Surgical Enhanced Recovery Pathways: a Review. [2019]
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