Non-pharmacological Pain Management for Post-Spine Surgery Pain

Not currently recruiting at 3 trial locations

Overseen By Mary Laugesen, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dan Rhon

Disqualifiers: Infection, Fracture, Tumor, Trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods for managing pain after lumbar spine surgery. One group receives standard care, which includes opioids (strong painkillers). The other group follows an enriched pain management pathway (EPM), combining standard care with physical therapy and mindfulness exercises. The trial aims to determine which approach leads to better recovery and reduced opioid use. Individuals scheduled for lumbar spine surgery due to conditions like disc herniation or spinal stenosis, and who can attend follow-up sessions, might be suitable candidates. As an unphased trial, this study offers patients the chance to explore innovative pain management strategies that could enhance recovery and reduce opioid reliance.

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 prior data suggests that these pain management pathways are safe for post-spine surgery patients?

Research has shown that non-drug treatments, such as those in the Enriched Pain Management Pathway (EPM), are generally easy for patients to handle. EPM includes physical therapy and mindfulness practices, which have shown promise in managing pain without the side effects often associated with medications.

Studies have found that these methods can help reduce pain after spine surgery. Patients using these approaches often experience fewer side effects compared to those using standard pain treatments, which usually involve opioids. While opioids are strong painkillers, they can cause side effects like nausea or drowsiness.

Physical therapy and mindfulness can effectively manage pain and reduce the need for opioids, which many people find beneficial. Overall, this suggests that the enriched approach is safe for most patients, with few reports of issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Enriched Surgical Management Pathway (EMP) because it offers a non-pharmacological approach to managing post-spine surgery pain. Unlike standard care that primarily relies on opioids, EMP incorporates physical therapy and mindfulness techniques. This holistic approach aims to reduce reliance on medication, potentially lowering the risk of opioid-related side effects and improving overall recovery outcomes. By focusing on both physical and mental aspects of recovery, EMP could offer a more comprehensive and effective pain management strategy.

What evidence suggests that these pain management pathways are effective for post-spine surgery pain?

Research has shown that non-drug treatments can help manage pain after spine surgery. In this trial, participants may receive the Enriched Pain Management Pathway (EPM), which includes physical therapy and mindfulness. This approach has shown promise in reducing pain and the need for opioids after surgery. Studies suggest these methods can aid recovery and reduce the use of pain medications. For those undergoing lumbar spine surgery, these non-drug approaches might enhance pain management and overall recovery. ^{1 2 3 4 6}

Who Is on the Research Team?

Daniel Rhon, PhD

Principal Investigator

Brooke Army Medical Center

Julie M Fritz, PhD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Standard Care (SC) Active Control 1 Intervention

Standard Post-Surgical Care utilizing opioids.

Group II: Enriched Surgical Management Pathway (EMP) Active Control 1 Intervention

Enriched Surgical Management Pathway utilizing Physical Therapy and Mindfulness in addition to Standard Protocol.

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proposed pathway for patients undergoing enhanced recovery after spinal surgery: protocol for a systematic review. Licina, A., Silvers, A., Laughlin, H., et al.[2023]

A national care pathway for managing low back pain and radicular pain was developed in Belgium, integrating insights from 11 international pathways and 7 local initiatives, emphasizing the importance of multidisciplinary teamwork.

The pathway was constructed through a consensus approach involving various healthcare professionals and is based on established guidelines, making it a practical tool for caregivers and patients in Belgium.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Depreitere, B., Jonckheer, P., Coeckelberghs, E., et al.[2020]

In a systematic review of 86 randomized controlled studies involving 6284 participants, triple-drug therapy (paracetamol, nonsteroidal anti-inflammatory drugs, and an adjunct) was found to be the most effective pain management strategy for adult spine surgery, significantly reducing morphine consumption by an average of 26 mg and pain scores by 2.3 points at 24 hours post-surgery.

The analysis demonstrated that the effectiveness of pain relief interventions increased with the number of drugs used, highlighting the importance of multimodal approaches in managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of perioperative pharmacological and regional pain interventions in adult spine surgery: a network meta-analysis and systematic review of randomised controlled trials. Bae, S., Alboog, A., Esquivel, KS., et al.[2022]

Enhanced recovery pathways are structured programs that use evidence-based interventions to standardize surgical techniques, improve patient outcomes, and reduce hospital costs, including facilitating earlier discharges after surgery.

Despite their proven benefits and 20-year history, many clinical teams have yet to adopt these pathways, highlighting the need for increased outreach and formal guidelines to promote their implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Evolution of Surgical Enhanced Recovery Pathways: a Review. Elhassan, A., Ahmed, A., Awad, H., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Postoperative Pain in Patients Following Spine Surgery: A Narrative Review. Prabhakar, NK., Chadwick, AL., Nwaneshiudu, C., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using drug monitoring programs to optimize pain management for elective surgery patients. Lowry, R.[2018]

Fast-track surgery (FTS) combined with specialized pain care significantly reduces postoperative pain and complications in spinal surgery patients, as shown by lower numeric rating scale (NRS) scores and reduced adverse effects compared to standard care.

Patients receiving the combined FTS and pain care intervention experienced faster recovery times, including shorter time to get out of bed and reduced length of hospital stay, along with higher nursing satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Fast-Track Surgery with Pain Care on Postoperative Pain Improvement and Complication Prevention in Perioperative Spine Surgery Patients. Xie, G., Liu, F., Fan, L., et al.[2022]

The IMPAKT ERAS trial is a large-scale study involving 1544 patients undergoing major abdominal surgery, investigating the effects of perioperative ketamine infusions on functional recovery and opioid consumption within Enhanced Recovery After Surgery (ERAS) pathways.

This pragmatic, randomized, placebo-controlled trial aims to determine if adding ketamine to standard multimodal analgesic regimens can reduce hospital length of stay and improve clinical outcomes, potentially enhancing recovery after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The IMpact of PerioperAtive KeTamine on Enhanced Recovery after Abdominal Surgery (IMPAKT ERAS): protocol for a pragmatic, randomized, double-blinded, placebo-controlled trial. Raymond, BL., Allen, BFS., Freundlich, RE., et al.[2023]

In a study of 236 patients undergoing elective laparotomy, the use of epidural analgesia (EA) did not significantly reduce overall postoperative opioid consumption compared to those who did not receive EA.

Interestingly, patients with EA had higher opioid use on postoperative day three, suggesting that EA may not provide the expected benefits in reducing opioid requirements after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of epidural analgesia on postoperative opioid requirements following elective laparotomies performed at Vancouver General Hospital. Leung, P., Albarrak, AA., Rahavi, A., et al.[2021]

A rapid recovery pathway (RRP) for adolescent idiopathic scoliosis patients undergoing spinal fusion surgery significantly reduced opioid consumption in the first two postoperative days, with a mean difference of 61.6 morphine milligram equivalents (MME) compared to traditional methods.

Patients in the RRP group also experienced a shorter hospital stay, averaging 2.5 days compared to 4.0 days for those receiving epidural catheter analgesia, indicating that the RRP can effectively accelerate recovery without compromising pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid recovery pathway without epidural catheter analgesia for surgical treatment of adolescent idiopathic scoliosis: a comparative study. Colón, LF., Powell, C., Wilson, A., et al.[2023]

The IMPAKT ERAS trial is a large-scale study involving 1544 patients undergoing major abdominal surgery to evaluate the impact of perioperative ketamine infusions on functional recovery and opioid consumption within Enhanced Recovery After Surgery (ERAS) pathways.

This pragmatic, randomized, placebo-controlled trial aims to determine if adding ketamine to the multimodal analgesic regimen can reduce hospital length of stay and improve clinical outcomes, potentially enhancing recovery while minimizing opioid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The IMpact of PerioperAtive KeTamine on Enhanced Recovery after Abdominal Surgery (IMPAKT ERAS): protocol for a pragmatic, randomized, double-blinded, placebo-controlled trial. Raymond, BL., Allen, BFS., Freundlich, RE., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04770480

Non-pharmacological Treatment for Pain After Spine Surgery This study will compare the effectiveness of two pain management pathways (standard vs. enriched) for patients undergoing lumbar spine surgery in the ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04770480

Non-pharmacological Treatment for Pain After Spine Surgery This study will compare the effectiveness of two pain management pathways (standard vs. enriched) for patients undergoing lumbar spine surgery in the ...

3. withpower.com withpower.com/trial/phase-chronic-pain-5-2021-7f4b0

Non-pharmacological Pain Management for Post-Spine ... This study will compare the effectiveness of two pain management pathways (standard vs. enriched) for patients undergoing lumbar spine surgery in the ...

4. trial.medpath.com trial.medpath.com/clinical-trial/3c65e16d5b82184d/exploring-non-pharmacological-pain-management-lumbar-surgery

Non-pharmacological Treatment for Pain After Spine Surgery This study will compare the effectiveness of two pain management pathways (standard vs. enriched) for patients undergoing lumbar spine surgery in the ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12195711/

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 and ...

6. link.springer.com link.springer.com/article/10.1007/s40122-024-00688-1

A Review of Non-pharmacological Interventions | Pain and ... This study aimed to synthesize evidence on the efficacy of nondrug approaches for managing postoperative pain.