Evaluating spine pain intervention options

Currently available treatment options for spine pain are mostly focused on symptom control and include physical therapy, pain medications, spine manipulation, interventional spine procedures, cognitive behavioral therapy, spinal cord stimulation and surgery. Newer regenerative therapies using patient-derived stem cells have been recently proposed to treat — and potentially cure — the underlying causes of back pain.

In the clinical setting, attempts to evaluate and compare the effectiveness of various treatments for spine pain can be challenging. Due to an insufficient evidence base, there is no consensus among providers on optimal spine care pathways, including spine interventions. Although experts recognize that a spine pain registry would help providers make evidence-based decisions for patients with these conditions, the development of such a registry has been challenging, and no high-quality registry exists today.

To address this issue, a research team led by Wenchun Qu, M.D., Ph.D., M.S., and William D. Mauck, M.D., has launched an integrated, multidisciplinary effort called the Gerstner Spine Pain Initiative. Dr. Qu is a specialist in physical medicine and rehabilitation and pain at Mayo Clinic's campus in Rochester, Minnesota. His research focuses on spine regenerative therapies. Dr. Mauck is an anesthesiologist and chair of Pain Medicine at Mayo Clinic's campus in Rochester, Minnesota.

The Gerstner Spine Pain Initiative, made possible by a grant from The Louis V. Gerstner, Jr. Fund at Vanguard Charitable, is designed to have a direct impact on how clinicians care for their patients with spine pain. The initiative comprises two interrelated components:

  • The development and implementation of a patient outcomes database and data collection platform to support critical evaluation of best practices and clinical trial planning, implementation and critical appraisal: This outcomes database will be scaled to include all phases of spine care: primary care, spine specialty care, image-guided procedures, regenerative therapy and surgical interventions. It will also include standardized data and information drawn from Mayo Clinic's extensive electronic medical records environment.
  • The completion of a randomized, controlled, clinical trial of a novel and promising therapeutic strategy based on emerging regenerative technologies developed at Mayo, which will complement and contribute to the database and serve as a demonstration pilot for the initiative: This trial will evaluate the curative potential of stem cell therapy for treatment of degenerative arthritis of lumbar facet joints and establish a model of clinical study for regenerative therapy for spine pain.

According to Dr. Qu and colleagues, a comprehensive registry will address several patient-centered questions related to spine care and serve as the foundation for making individualized treatment plans and guiding future directions for innovation, allowing clinicians to:

  • Define the right treatment plan for each patient
  • Understand treatment gaps
  • Provide future directions for new interventions for spine pain

"Our goal is to create a spine pain registry with large-scale data collection that will allow rigorous analysis of established and novel pain interventions," explains Dr. Qu. "Learning from the reliability and success of industry-sponsored clinical trials, we recognize that the quality and rigor of the registry dwell in a system that is built at the level of a clinical trial," explains Dr. Qu.

The Gerstner Spine Pain Initiative will establish and demonstrate an integrated model that will elevate Mayo Clinic's capacity to research and treat spine pain conditions. Dr. Qu envisions multiple ways in which this project will benefit clinicians and researchers alike.

"This resource will guarantee high-quality data for the broad range of spine conditions treated by clinicians and provide resources for ongoing and future clinical trials," says Dr. Qu.