Non-pharmacological Treatment for Pain After Spine Surgery

Last updated: January 13, 2025
Sponsor: Dan Rhon
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Surgery

Pain

Treatment

Standard Care (SC)

Enriched Pain Management Pathway (EPM)

Clinical Study ID

NCT04770480
eIRB
3UH3AT009763-04S1
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 belaminectomy with or without fusions including lateral, transforaminal, posterior oranterior approach for 1-4 lumbar levels. Surgery may be performed in military orcivilian 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 thesurgical procedure with no planned absence of 2 weeks or more for training, vacationor any purpose

Exclusion

Exclusion Criteria:

  1. Indication for surgery is infection, fracture, tumor, trauma or other indicationrequiring emergency surgery.

  2. A microsurgical technique as the primary procedure, such as an isolated laminotomyor microdiscectomy

  3. Surgical procedure is a revision or participant has undergone a lumbar surgicalprocedure in the past year.

  4. Contra-indication to participation in post-operative exercise program includingsevere orthopedic injury limiting mobility, wheelchair dependency, neurologicaldisorder 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

Study Design

Total Participants: 272
Treatment Group(s): 2
Primary Treatment: Standard Care (SC)
Phase:
Study Start date:
December 10, 2021
Estimated Completion Date:
March 30, 2026

Study Description

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.

Connect with a study center

  • Tripler Army Medical Center

    Honolulu, Hawaii 96859
    United States

    Site Not Available

  • Brooke Army Medical Center

    San Antonio, Texas 78234
    United States

    Active - Recruiting

  • Madigan Army Medical Center

    Tacoma, Washington 98391
    United States

    Site Not Available

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