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Non-pharmacological Pain Management for Post-Spine Surgery Pain

N/A
Recruiting
Led By Julie M Fritz, PhD
Research Sponsored by Dan Rhon
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Anticipates ability to attend treatment sessions over a 16 week period following the surgical procedure with no planned absence of 2 weeks or more for training, vacation or any purpose
Age 18 - 75 years at the time of enrollment
Must not have
Indication for surgery is infection, fracture, tumor, trauma or other indication requiring emergency surgery
Contra-indication to participation in post-operative exercise program including severe orthopedic injury limiting mobility, wheelchair dependency, neurological disorder impacting mobility, reliance on supplemental oxygen for daily activity, etc
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare two ways of managing pain after lumbar spine surgery in the Military Health System. One group will receive the standard care, while the other will get an enriched care pathway with the hope of reducing opioids use.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial focuses on non-pharmacological treatments, side effects may include discomfort from participation in the post-operative exercise program but do not typically involve drug-related side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can attend all treatment sessions for 16 weeks after surgery without taking a 2-week break.
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I am between 18 and 75 years old.
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I am scheduled for lower back surgery within the next 2 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need surgery urgently due to infection, fracture, tumor, trauma, or another emergency.
Select...
I do not have any health issues that prevent me from joining an exercise program after surgery.
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I have had a lumbar surgery or a revision in the past year.
Select...
I had a microsurgery like a laminotomy or microdiscectomy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain, Enjoyment, and General Activity Scale (PEG-3)
Secondary study objectives
Time to Discontinuation of Opioids After Surgery
Other study objectives
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 version 2.0

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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 Location

Who is running the clinical trial?

59th Medical WingFED
40 Previous Clinical Trials
12,378 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
866 Previous Clinical Trials
674,564 Total Patients Enrolled
Brooke Army Medical CenterFED
129 Previous Clinical Trials
27,365 Total Patients Enrolled
Dan RhonLead Sponsor
1 Previous Clinical Trials
116 Total Patients Enrolled
University of UtahOTHER
1,147 Previous Clinical Trials
1,699,349 Total Patients Enrolled
Madigan Army Medical CenterFED
48 Previous Clinical Trials
17,566 Total Patients Enrolled
Tripler Army Medical CenterFED
20 Previous Clinical Trials
27,377 Total Patients Enrolled
Julie M Fritz, PhDPrincipal InvestigatorUniversity of Utah
3 Previous Clinical Trials
1,014 Total Patients Enrolled
Daniel I Rhon, DScPrincipal InvestigatorBrooke Army Medical Center
2 Previous Clinical Trials
1,150 Total Patients Enrolled

Media Library

Enriched Pain Management Pathway (EPM) Clinical Trial Eligibility Overview. Trial Name: NCT04770480 — N/A
Chronic Lower Back Pain Research Study Groups: Standard Care (SC), Enriched Surgical Management Pathway (EMP)
Chronic Lower Back Pain Clinical Trial 2023: Enriched Pain Management Pathway (EPM) Highlights & Side Effects. Trial Name: NCT04770480 — N/A
Enriched Pain Management Pathway (EPM) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04770480 — N/A
~49 spots leftby Aug 2025
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