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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain, Enjoyment, and General Activity Scale (PEG-3)

Secondary outcome measures

Time to Discontinuation of Opioids After Surgery

Other outcome measures

Patient-Reported Outcomes Measurement Information System (PROMIS)-29 version 2.0

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

59th Medical WingFED

39 Previous Clinical Trials

12,228 Total Patients Enrolled

National Center for Complementary and Integrative Health (NCCIH)NIH

833 Previous Clinical Trials

669,181 Total Patients Enrolled

Brooke Army Medical CenterFED

119 Previous Clinical Trials

26,287 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this investigative trial have age restrictions, and if so, are those over fifty eligible to participate?

"According to the trial's eligibility requirements, applicants must be aged 18-75 years old. There are 73 trials for minors and 832 specifically meant for seniors."

Answered by AI

Does this trial fit my criteria to participate?

"This clinical trial seeks 272 individuals who suffer from lumbar pain, aged 18 to 75. Eligibles are required to commit themselves for 16 weeks of treatment following their surgical procedure and cannot anticipate any prolonged absences due the next 60 days. Surgery may be a laminectomy with or without fusion, conducted through anterior, posterior, lateral or transforaminal approaches at 1-4 vertebral levels in either civilian or military hospitals; all for herniated discs, degenerative disc disease, stenosis and scoliosis among others."

Answered by AI

Has this research project begun to accept participants yet?

"As indicated on clinicaltrials.gov, this medical experiment is currently seeking participants; it was initially posted on the 10th of December 2021 and recently revised on April 1st 2022."

Answered by AI

How many research subjects are being monitored in this investigation?

"Affirmative. Clinicaltrials.gov hosts information verifying this medical study's current recruitment status; it was first introduced on December 10th 2021, and modified most recently on January 4th 2022. This research seeks 272 participants from four different facilities."

Answered by AI