Title: Improving Surgical Outcomes with Early Physical Therapy after Anterior Cervical Discectomy and Fusion (ACDF)

Funded by the Department of Defense (HT94252310300), PI: Archer, Vanderbilt University Medical Center

Over the last three decades, there has been an increase in the rate of ACDF surgery. Despite the increased utilization, up to 40% of civilian patients report persistent pain and disability as well as dissatisfaction following ACDF and up to 20% of patients in the military have difficulty returning to duty and meeting criteria for a successful outcome. Biomechanical and preliminary clinical evidence highlight the safety and potential effectiveness of early exercise after ACDF; however, data are needed to support the use of neck specific exercises early after surgery. Our clinical trial will be the first to assess the benefit of adding early postoperative physical therapy (PT) to the ACDF recovery pathway. This proposed study will conduct a phase II two-group randomized controlled trial comparing early and delayed PT in patients following ACDF. The central hypothesis is that an early structured PT intervention performed within the first three months of ACDF will have a measurable impact on the primary outcome of disability and secondary pain and functional outcomes.

Title: Postoperative Telehealth Mindfulness Intervention to Improve Pain-related Outcomes and Reduce Opioid Use after Lumbar Spine Surgery 

Funded by the National Center for Complementary and Integrative Health (K23AT011569), PI: Brintz, Vanderbilt University Medical Center

The proposed study will address the significant and complex public health problems of postsurgical chronic pain and the opioid epidemic utilizing a biopsychosocial paradigm that is recommended but not yet well-integrated in orthopaedic surgical practice.  Effective nonpharmacological treatment options that address pain and common psychosocial risk factors after spine surgery are needed but have not been tested and widely disseminated.  The proposed study will adapt and refine a telehealth mindfulness-based intervention that addresses the unique pain concerns facing the large number of patients who undergo lumbar spine surgery and will provide important data on feasibility to inform the development of future trials investigating efficacy, mechanisms, and predictors of treatment response.

Title: Spine Pain Intervention to Enhance Care Quality and Reduce Expenditure (SPINE CARE)

Funded by Stanford Clinical Excellence Research Center,PIs: Milstein, Stanford and Choudhry, Harvard; Site PI: Archer, Vanderbilt University Medical Center 

Low back and neck pain are among the leading causes of medical visits, lost productivity and disability. There is an urgent need to identify effective and efficient ways of helping patients with acute spine pain while guiding practitioners towards high-value care. This multi-center pragmatic trial will randomize patients with acute spine pain to one of three treatment strategies, Identify, Coordinate and Enhanced decision making (ICE) care model, Individualized Postural Therapy, and usual care. SPINE-CARE trial is a collaboration between Stanford, Harvard, and Vanderbilt University Medical Center. (https://clinicaltrials.gov/ct2/show/NCT03083886)

Title: Comparative Effectiveness of Postoperative Management for Degenerative Spinal Conditions

Funded by the Patient-Centered Outcomes Research Institute (PCORI), PI: Archer, Vanderbilt University Medical Center    

The United States has the highest rate of lumbar spine surgery in the world, with rates increasing over 200% in the last decade. These surgeries account for over $1 billion spent annually by Medicare. Despite surgical advances, up to 40% of older adults have persistent pain, disability and functional limitations. We have found that psychosocial factors, such as fear of movement, are risk factors for increased pain and disability following lumbar spine surgery. Brief cognitive-behavioral therapy and self-management treatments have proven effective for reducing psychosocial risk factors. However, these treatments are unavailable or insufficiently adapted for postoperative care.

This multi-center randomized controlled trial will randomize patients undergoing spine surgery to cognitive behavioral-based physical therapy (CBPT) program or an education program. Patients will be followed for 1 year following surgery to assess pain, disability, physical activity, physical function, and general health. (https://clinicaltrials.gov/ct2/show/NCT02184143)




Title: The Effect of an Early Home Exercise Program on Outcomes after Cervical Spine Surgery

Funded by Cervical Spine Research Society, PI: Coronado, Vanderbilt University Medical Center

Degenerative cervical spine conditions such as spinal stenosis and cervical disk disease are the most common reasons for fusion surgery.  Anterior cervical discectomy and fusion (ACDF) surgery is the most commonly performed cervical spine surgery. An estimated 771,932 individuals underwent ACDF surgery between 1994 and 2004 in the U.S. Total hospital costs associated with ACDF surgery exceed $17,000 per admission. Despite an increase in surgery, up to 65% of patients show poor outcomes in long-term disability, quality of life, and functioning. 

This randomized controlled trial examines the efficacy and safety of an early home exercise program (HEP) for improving disability, pain, general health, and physical activity compared to usual care after ACDF surgery for degenerative cervical spine disease. (https://clinicaltrials.gov/ct2/show/NCT02720172)


Title: Physical Activity Telehealth Intervention: Improving Outcomes after Spine Surgery (PASS Trial)

Funded by Academy of Orthopaedic Physical Therapy and Vanderbilt Center for Musculoskeletal Research, PIs: Archer/Master, Vanderbilt University Medical Center

Over the past decade, spine surgery rates for degenerative lumbar conditions have nearly doubled in the United States, resulting in over $10 billion in aggregate hospital costs. Conventional postoperative physical therapy is known to improve lower body strength and physical function after spine surgery. However, over 80% of patients do not engage in physical activity after spine surgery. Thus, there is a critical need to target physical activity during postoperative management to optimize long-term recovery after spine surgery. We have developed a postoperative physical activity telehealth intervention, which will be delivered by a physical therapist. The intervention includes wearable technology and physical therapist support to counsel patients on a realistic progression of physical activity (steps per day).

This randomized controlled trial examines the efficacy of a physical activity telehealth intervention delivered by a physical therapist for improving physical activity, disability and pain compared to usual care after spine surgery for a degenerative lumbar condition. (Clinicaltrials.gov/NCT04968821)