Non-pharmacological Treatment for Pain After Spine Surgery

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.

Conditions

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

Interventions

BEHAVIORAL

Standard Care (SC)

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

BEHAVIORAL

Enriched Pain Management Pathway (EPM)

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).

Sponsors & Collaborators

• University of Utah

  collaborator OTHER

• Madigan Army Medical Center

  collaborator FED

• Tripler Army Medical Center

  collaborator FED

• 59th Medical Wing

  collaborator FED

• National Center for Complementary and Integrative Health (NCCIH)

  collaborator NIH

• Brooke Army Medical Center

  collaborator FED

• Dan Rhon

  lead FED

Principal Investigators

• Julie M Fritz, PhD · University of Utah

• Daniel I Rhon, DSc · Brooke Army Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-10

Primary Completion

2025-11-30

Completion

2026-03-30

Countries

• United States

Study Locations