The proposed project addresses the significant healthcare need of providing a new non-narcotic (non-opioid) therapy for patients with chronic back pain and other musculoskeletal disorders, by evaluating a minimally invasive medical device. The device is a percutaneous peripheral nerve stimulation (PNS) system designed to relieve pain, decrease or eliminate opioid use, and reduce disability, enabling improvements in function (i.e., improving an individual’s ability to complete daily activities or occupational tasks) in Service members, Veterans, other military health system beneficiaries, and civilians. The proposed project directly addresses five areas of encouragement in the Fiscal Year 2017 Peer Reviewed Medical Research Program Topic Areas of Musculoskeletal Disorders: (1) Research on lower back pain strategies to prevent surgery and recurrence of symptoms and encourage self-management as a treatment; (2) treatment of overuse musculoskeletal disorders, and non-opioid pain management: (3) research on treatments for chronic pain management, particularly in complex patients; (4) comparative studies evaluating the efficacy of different pain management strategies; and (5) research on pain management strategies for patients with limited access to skilled providers and resources.

Objectives and Rationale: The objective of the proposed study is to evaluate the safety and effectiveness of percutaneous PNS, a non-surgical, minimally invasive intervention to reduce pain, usage of pain medication (including both opioids and non-opioids), and disability, to enable improvements in function among Service members, Veterans, and civilians with chronic back pain from trauma or overuse injury. Musculoskeletal injuries caused by trauma or overuse are a major problem in the US military, resulting in high rates of pain, opioid use, disability, decreased military readiness, and lost work time. Chronic back pain is the most common type of musculoskeletal pain, representing a significant burden because the pain is complex and challenging to treat. Chronic back pain interferes with function and daily activities (such as walking, work, and personal care) and decreases quality of life. As the leading cause of morbidity in the US military, back pain is the most commonly diagnosed injury or reason for seeking medical care and has the highest 5-year risk of permanent disability. A diagnosis of back pain is associated with an increased likelihood of receiving opioids, and opioid abuse is extremely common among this population. When medications and other conservative treatments fail, patients often turn to invasive surgical treatments for their back pain, but surgery for back pain is often expensive, irreversible, and frequently fails. A new pain management strategy is needed to effectively treat back pain without opioids or invasive surgery. The proposed study is a Phase II randomized controlled trial (RCT) that will test the ability of percutaneous PNS to decrease chronic back pain and reduce medication to enable improvements in patient function. The primary goal is to make available to the US military a safe and effective non-opioid treatment for musculoskeletal disorders that will reduce opioid use and disability. The efficacy of percutaneous PNS will be compared to a commonly used surgical intervention to determine if the proposed nonsurgical approach provides superior pain relief and reduces analgesic use, enabling improvements in function.

Applicability: The proposed research is intended to help Service members, Veterans, and civilians suffering from chronic back pain and other musculoskeletal disorders. The proposed study was designed based on promising results from multiple clinical studies, including the previous Phase I feasibility studies, in which the proposed percutaneous PNS system produced sustained clinically significant reductions in pain, reduced opioid use, and reduced disability in a majority of patients with back pain. This research will benefit patients by allowing them to self-manage the treatment of their back pain with a non-opioid therapy and experience pain relief, reduced opioid use, and reduced disability (improved function) without undergoing invasive surgery.

Impact: The proposed project supports the US military’s interest in improving the treatment of back pain and other musculoskeletal disorders following trauma and overuse injuries. The development of a novel non-opioid, non-surgical treatment for chronic back pain (a complex pain syndrome) will help solve a significant problem in military and Veteran populations that causes severe disability and is a leading cause for separation from duty. Management of pain, elimination of opioid use, and functional recovery are critical to preventing premature discharge from duty, enabling Service members to return to duty, and maintaining unit readiness in patients with chronic back pain. If successful, the proposed therapy will reduce a serious burden on the military health system and may reduce costs associated with the management of chronic back pain and other musculoskeletal disorders. The goal is to improve patient care for military Service members, Veterans, their families, and civilians with a non-opioid, non-surgical treatment that can be administered sooner after musculoskeletal trauma or overuse injury (e.g., in resource-limited environments closer to the battlefield by multiple types of physicians with minimal additional training) to reduce pain, opioid use, and disability to enable improvement in function.