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Active, Not Recruiting

NCT Number: NCT04770480

Non-pharmacological Treatment for Pain After Spine Surgery

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tripler Army Medical Center, Honolulu, Hawaii, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

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

    Time frame: 6 Months

    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.

Secondary outcomes

  1. Time to Discontinuation of Opioids After Surgery

    Time frame: 6 Months

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

Other outcomes

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

    Time frame: 6 months

    The PROMIS-29 measures 7 domains of health-related quality of life (pain interference, physical function, anxiety, depression, sleep disturbance, fatigue, and ability to participate in social roles) using 4 items and includes a single 0-10 numeric pain intensity rating scale. Scores are provided as T-scores for all domains and can be used to compute a mental and physical health summary score

Sponsors and collaborators

Lead sponsor

Dan Rhon

Fed

Collaborators

  • 59th Medical Wing
  • Brooke Army Medical Center
  • Madigan Army Medical Center
  • National Center for Complementary and Integrative Health (NCCIH)
  • Tripler Army Medical Center
  • University of Utah

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Feb 25, 2021
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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