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Chronic pain has been linked to anxiety and depression, reduced quality of life and dependence on opioids


Pain that lasts more than a few months is chronic pain. Some types can’t be cured. But treatment can help you find relief. The right choice for you depends on:

▪ How long the pain has lasted.
▪ How bad it is.
▪ What’s causing it.
▪ Where you hurt.

Chronic lower back pain, which is defined as moderate to severe pain in the lower back lasting longer than three months, is one of the most common chronic pain conditions in the U.S.

Chronic pain may inhibit mobility or daily activities and has been linked to anxiety and depression, poor perceived health or reduced quality of life and dependence on opioids.

Millions of adults in the United States are living with chronic lower back pain that can affect multiple aspects of their daily life.


Treatments have changed a lot over the years, and there are more options than ever:

▪ Radiofrequency Ablation (RFA).

▪ Pain Shots.

▪ Opioids.

▪ Antidepressants.

▪ Anti-seizure medications.

▪ Muscle relaxants.

▪ Acupuncture.

▪ Massage, spinal adjustment, and yoga.

▪ Cognitive behavioral therapy (CBT) may be used to reduce the burden of chronic pain and increase function through an emotional, cognitive approach to shift negative beliefs held by patients.


Opioids are powerful and very effective for severe pain. They include Fentanyl, Hydrocodone (Vicodin), Methadone, Oxycodone (OxyContin). Opioid drugs can cause addiction, also known as opioid use disorder (OUD). About 8 percent to 12 percent of patients who take prescription opioids for chronic pain (a longer course of treatment than that for acute pain) develop OUD.

Symptoms of opioid use include drowsiness, constipation, euphoria, nausea, vomiting and slowed breathing. A person using opioids over time can develop tolerance, physical dependence and opioid use disorder, requiring higher and more frequent doses, with the risk of overdose and death.

The risk of respiratory depression (slowing) or respiratory arrest (when breathing stops completely) is higher in people who:

  • Are taking an opioid drug for the first time.
  • Are taking other medications that interact with the opioid.
  • Have a disease or condition that affects their ability to breathe.

Although federal funding to address the opioid crisis has increased in recent years, opioid overdose mortality has increased as well. Deaths from opioid-involved overdoses were among the leading causes of death. Opioid prescribing increased as a result of aggressive promotion efforts by pharmaceutical companies and reimbursement incentives in the health care system. Some promotional materials also understated the addictive potential of prescription opioids.

Medications for OUD that have been approved by the Food and Drug Administration include methadone, buprenorphine, and naltrexone. Another drug, naloxone, can reverse opioid overdoses but does not treat the underlying OUD. However, treatment for OUD is underused because of affordability, lack of access, and stigma associated with OUD.

More recently, demand for heroin and fentanyl and related substances increased because of lower prices for those drugs and reduced availability of prescription opioids.

So, what is new? At the end of the eight weeks of treatment, greater than 30% – 50% reduction in pain (pain interference on activity, pain interference on mood, pain interference on sleep and pain interference on stress).

This prescription device, which is intended for at-home self-use, consists of a VR headset and a controller, along with a “Breathing Amplifier” attached to the headset that directs a patient’s breath toward the headset’s microphone for use in deep breathing exercises.

The U.S. Food and Drug Administration authorized the marketing of EaseVRx, a prescription-use immersive virtual reality (VR) system that uses cognitive behavioral therapy and other behavioral methods to help with pain reduction in patients 18 years of age and older with diagnosed chronic lower back pain.

FDA evaluated the safety and effectiveness of EaseVRx in a randomized, double-blinded clinical study. No serious adverse events were observed or reported, but only discomfort with the headset and motion sickness and nausea.


Devices that are classified into class I or class II through a De Novo classification request (De Novo request) may be marketed and used as predicates for future premarket notification 510(k) submissions, when applicable.

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