Heavy lifting: New NIH consortium takes on back pain and opioid use

Back pain is often cited as one of the most frequent reasons patients visit HCPs for pain relief options. The NIH created the Back Pain Consortium (BACPAC) to conduct trials to help determine which back pain treatments are most effective for specific individuals. The goal is to help HCPs reduce the need to prescribe opioids for chronic low back pain.

Back pain: The data

The National Center for Health Statistics (NCHS), part of the CDC, published a data brief showing the extent of back pain in the US.^[]

Based on findings from the National Health Interview Survey, they reported that, in 2019, nearly 3 in 5 adults (58.9%) had experienced pain of any kind in the prior 3 months. Back pain affected 39.0% of adults. Other common types of pain were lower limb pain, in 36.5%, and upper limb pain, in 30.7%. The prevalence of pain increased with age, and was highest among adults older than age 65.

BACPAC explained

BACPAC is a translational, patient-centered effort to identify such treatments using interdisciplinary methods.^[] The BACPAC Research Program will accomplish three goals:

1. Develop a state-of-the-art model for chronic low back pain, incorporating biological, biomechanical, psychosocial, and other factors

2. Identify and test treatments that target specific pathways

3. Conduct a large-scale clinical study to develop a management algorithm based on back pain phenotype

BACPAC stakeholders include patients, providers, medical associations, payors, pharmaceutical companies, and government organizations. The BACPAC Research Program is federally funded through the NIH and the Helping to End Addiction Long-term® (HEAL) Initiative. 

BEST trial 

The Biomarkers for Evaluating Spine Treatments (BEST) clinical trial is underway as part of the BACPAC Research Program.^[] For the BEST trial, chronic low back pain is defined as back pain lasting at least 3 months, and occurring “at least half the days in the past 6 months.” The trial will last 38 weeks.

The goal of this precision medicine study is to find links between individual biomarkers and the effectiveness of four existing back pain treatments:

• Acceptance and commitment therapy (an established approach that focuses on the whole person, their pain, health, and quality of life, while helping them learn new skills for dealing with pain)

• Duloxetine, a generic serotonin-norepinephrine reuptake inhibitor 

• Enhanced self-care (an online program that uses personalized messaging to teach evidence-based strategies and lifestyle skills to help patients manage their pain)

• Evidence-based exercise and manual therapy (a combination of simple exercises, such as basic stretches and strength training, and hands-on treatment by a physical therapist or chiropractor)

Trial participants will receive one or two of the above treatments. 

HEAL Initiative

According to an Informational Briefing for the HEAL Initiative, in 2021, more than 100,000 Americans died from drug overdoses, and more than 80,000 of those deaths were from opioids.^[] 

The NIH has invested more than $2.5 billion in this program to fund more than 1,000 projects in all 50 states. 

Preventing opioid use disorder 

The NIH also has another, separate initiative for preventing opioid use disorder.^[] The rationale for this program is based on sobering statistics: Responses to the 2020 National Survey on Drug Use and Health indicated that 9.5 million people aged 12 or older had misused opioids in the previous year, and 2.7 million people had an opioid use disorder. 

Many strategies for preventing substance use disorders—especially involving opioids—have been implemented, but their efficacy has not been well-demonstrated. 

An important objective for the research is to build an evidence base for prevention interventions and to identify social determinants. Associations between tobacco, cannabis, and opioid use will also be examined.