Non-pharmacological Treatment for Pain After Spine Surgery

Not Applicable

Recruiting

• Conditions: Surgery; Low Back Pain; Back Pain Lower Back Chronic; Chronic Pain; Back Pain, Low
• Interventions: Behavioral: Standard Care (SC); Behavioral: Enriched Pain Management Pathway (EPM)

• Registration Number: NCT04770480
• Lead Sponsor: Dan Rhon

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-02-22
• Study First Submitted QC: 2021-02-22
• Study First Posted: 2021-02-25
• Study Start: 2021-12-10
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-14
• Primary Completion: 2025-10-30
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 272

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Care (SC)	Standard Care (SC)	Standard Post-Surgical Care utilizing opioids.
Enriched Surgical Management Pathway (EMP)	Enriched Pain Management Pathway (EPM)	Enriched Surgical Management Pathway utilizing Physical Therapy and Mindfulness in addition to Standard Protocol.

Primary Outcome Measures

Name	Time	Method
Pain, Enjoyment, and General Activity Scale (PEG-3)	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 Outcome Measures

Name	Time	Method
Time to Discontinuation of Opioids After Surgery	6 Months	The length of time (recorded in days) until a patient discontinues pain medications after surgery.

Trial Locations

Locations (3)

Tripler Army Medical Center; 🇺🇸 Honolulu, Hawaii, United States

Madigan Army Medical Center; 🇺🇸 Tacoma, Washington, United States

Brooke Army Medical Center; 🇺🇸 San Antonio, Texas, United States