Non-pharmacological Treatment for Pain After Spine Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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The relevance of our model is supported by evidence that pain catastrophizing, self-efficacy and hypervigilance predict poor surgical outcomes and long-term opioid use. Surgery can exacerbate catastrophic thinking, especially if patients have unrealistic recovery expectations that go unmet. Physical therapy (PT) can improve chronic LBP (low back pain) outcomes, with effects mediated through changes in pain catastrophizing and self-efficacy. Mindfulness techniques help patients disentangle an experience (e.g., pain) from associated emotions and appraisals. Mindfulness can enhance emotion regulation and raise un-conscious behavioral responses (e.g., opioid use) to conscious consideration. The benefits of mindfulness for chronic pain are mediated by changes in hypervigilance and self-efficacy. Physical therapy and mindfulness can disrupt the self-reinforcing cycle of pain, catastrophic appraisal and unconscious behavioral response including opioid use. Our project examines an innovative strategy to integrate mindfulness and PT into an enriched surgical management pathway for individuals undergoing lumbar spine surgery. Patients at 3 different military hospitals will be randomized prior to surgery to two different treatment groups and followed for a period of 6 months, including the post-operative intervention phase.

Official Title
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Exploring Non-pharmacological Approaches to Pain Management After Lumbar Surgery: A Randomized Controlled Trial

Conditions
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Low Back Pain, Chronic Pain, Surgery, Back Pain, Low, Back Pain Lower Back Chronic

Intervention / Treatment
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* Behavioral: Standard Care (SC)
* Behavioral: Enriched Pain Management Pathway (EPM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Tricare beneficiary receiving care in a participating MHS facility. Age 18 - 75 years at the time of enrollment Scheduled to undergo lumbar spine surgery within the next 60 days. Surgery may be laminectomy with or without fusions including lateral, transforaminal, posterior or anterior approach for 1-4 lumbar levels. Surgery may be performed in military or civilian facility Indication for surgery may include disc herniation, degenerative disc disease, lumbar stenosis, degenerative spondylolisthesis or scoliosis. 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 Exclusion Criteria: Indication for surgery is infection, fracture, tumor, trauma or other indication requiring emergency surgery. A microsurgical technique as the primary procedure, such as an isolated laminotomy or microdiscectomy Surgical procedure is a revision or participant has undergone a lumbar surgical procedure in the past year. 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. Pending a medical evaluation board, discharge from the military for medical reasons, or pending or undergoing any litigation for an injury

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Primary Outcome: The primary analysis will be performed by fitting a longitudinal linear model to the PEG scores at baseline, 2 weeks and 26 weeks. Secondary Outcome: Kaplan Meier curves with 95% pointwise confidence limits will be constructed to summarize the time to opioid discontinuation in each of the EPM and SC treatment groups. Time to opioid discontinuation will be compared between groups using a stratified log-rank test, with stratification for three randomization stratification factors.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Care (SC)<br>Standard Post-Surgical Care utilizing opioids. | Behavioral: Standard Care (SC)<br>* No attempt will be made to change usual care practice after surgery<br>|
| Active Comparator: Enriched Surgical Management Pathway (EMP)<br>Enriched Surgical Management Pathway utilizing Physical Therapy and Mindfulness in addition to Standard Protocol. | Behavioral: Enriched Pain Management Pathway (EPM)<br>* Enriched Pain Management Pathway will be delivered by physical therapists trained to integrate physical therapy and mindfulness techniques grounded in a biopsychosocial context. The intervention will be delivered within the context of the post-operative physical therapy routine (the mindfulness approach will be integrated into the post-operative physical therapy care).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain, Enjoyment, and General Activity Scale (PEG-3) | The PEG-3 measure includes 3 items evaluating 1) pain severity, and interference of pain with 2) enjoyment and 3) general activity. Response options for each item range from 0-10 with higher scores indicating higher pain intensity. The PEG-3 score is expressed as the mean of all item scores. | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Discontinuation of Opioids After Surgery | The length of time (recorded in days) until a patient discontinues pain medications after surgery. | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic pain, low back pain, spine surgery, non-pharmacological treatment, mindfulness, physical therapy