Non-pharmacological Treatment for Pain After Spine Surgery

N/AActive Not RecruitingNCT04770480

Dan Rhon267 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

267

Conditions

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

Interventions

Standard Care (SC)BEHAVIORAL

No attempt will be made to change usual care practice after surgery

Enriched Pain Management Pathway (EPM)BEHAVIORAL

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Tricare beneficiary receiving care in a participating MHS facility. 2. Age 18 - 75 years at the time of enrollment 3. 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 4. Indication for surgery may include disc herniation, degenerative disc disease, lumbar stenosis, degenerative spondylolisthesis or scoliosis. 5. 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: 1. Indication for surgery is infection, fracture, tumor, trauma or other indication requiring emergency surgery. 2. A microsurgical technique as the primary procedure, such as an isolated laminotomy or microdiscectomy 3. Surgical procedure is a revision or participant has undergone a lumbar surgical procedure in the past year. 4. 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. 5. Pending a medical evaluation board, discharge from the military for medical reasons, or pending or undergoing any litigation for an injury

Locations (3)

Tripler Army Medical Center

Honolulu, Hawaii, United States

Brooke Army Medical Center

San Antonio, Texas, United States

Madigan Army Medical Center

Tacoma, Washington, United States

Outcomes

Primary Outcomes

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.

Time frame: 6 Months

Secondary Outcomes

Time to Discontinuation of Opioids After Surgery

The length of time (recorded in days) until a patient discontinues pain medications after surgery.

Time frame: 6 Months

Data from ClinicalTrials.gov

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