Comparing pain management methods after spine surgery

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

This study is testing two different ways to manage pain after spine surgery to see if adding mindfulness and physical therapy helps patients feel better and use fewer opioids.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 272 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Brooke Army Medical Center (fed)
• Locations: 3 sites (Honolulu, Hawaii and 2 other locations)
• Trial ID: NCT04770480 on ClinicalTrials.gov

What this trial studies

This study compares two pain management pathways for patients undergoing lumbar spine surgery within the Military Health System. It evaluates the effectiveness of standard care versus an enriched pain management pathway that integrates mindfulness techniques and physical therapy. The trial involves randomizing patients to one of the two treatment groups and following them for six months post-surgery to assess patient-centered outcomes and opioid use. The approach is based on the understanding that psychological factors like pain catastrophizing and self-efficacy significantly influence recovery and pain management.

Who should consider this trial

Good fit: Ideal candidates are Tricare beneficiaries aged 18 to 75 who are scheduled for lumbar spine surgery within the next 60 days.

Not a fit: Patients requiring emergency surgery for conditions like infection or trauma may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved pain management strategies that reduce opioid use and enhance recovery for patients after spine surgery.

How similar studies have performed: Previous studies have shown promise in using mindfulness and physical therapy for chronic pain management, suggesting potential success for this integrated approach.

Eligibility criteria

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

Where this trial is running

Honolulu, Hawaii and 2 other locations

• Tripler Army Medical Center — Honolulu, Hawaii, United States (NOT_YET_RECRUITING)
• Brooke Army Medical Center — San Antonio, Texas, United States (RECRUITING)
• Madigan Army Medical Center — Tacoma, Washington, United States (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Julie M Fritz, PhD — University of Utah
• Study coordinator: Mary Laugesen, DPT

Conditions: Low Back Pain, Chronic Pain, Surgery, Back Pain, Low, Back Pain Lower Back Chronic, chronic pain, low back pain, spine surgery