Home V.R. Therapy Shown to Reduce Back Pain

(NIH.gov)

7 Nov. 2023. A virtual reality program conducted at home is shown in a clinical trial to relieve chronic lower back pain intensity and improve daily living more than a sham V.R. program. Findings from the nationwide clinical trial assessing the therapy designed by the company AppliedVR appear in the 24 Oct. 2023 issue of Mayo Clinic Proceedings: Digital Health.

AppliedVR in Los Angeles applies virtual reality to therapeutics for conditions such as chronic pain, as well as behavioral and mental health disorders. The lead product from the eight year-old company is RelieVRx, a V.R. treatment for chronic lower back pain, performed by the patient at home, once a day for eight weeks. The company says its cognitive behavioral therapy combines diaphragmatic breathing, mindfulness, cognition and emotion regulation with pain education into daily immersive exercises. In addition, the V.R. headset uses a built-in microphone to capture audio of the user’s exhaling patterns as part of biofeedback in the program.

RelieVRx is available by prescription, and cleared by the Food and Drug Administration. The treatments are coded for reimbursement by Centers for Medicare and Medicaid Services and part of the Department of Veterans Affairs’ federal supply schedule.

The authors note that chronic lower back pain is the most prevalent pain condition worldwide, but opioid pain relievers are now too dangerous, resulting in fewer options for patients with the condition. And conventional behavioral therapies require a therapist, which reduces the availability of pain treatments without drugs.

Measures of pain intensity and interference

The clinical trial sampled 1,067 adults, age 18 to 85, with chronic lower back pain in the U.S., recruited by clinics, chronic pain organizations, and online advertisements. The sample was mainly women (72%) with an average age of 51. Participants were all given the same V.R. headsets, but randomly assigned to receive the RelieVRx program or a sham V.R. experience, consisting of non-immersive content such as two-dimensional nature videos and relaxing music. Data were collected directly from participants through online surveys through the Curebase clinical trial platform.

Both the RelieVRx and sham V.R. programs lasted eight weeks, with participants tracked for another 24 months. The study team looked primarily at scores on a standard Brief Pain Inventory questionnaire that measures participants’ evaluations of pain intensity, and pain interference or practical effects of pain on their daily lifestyles, such as mood, walking ability, work, sleep, and relations with others. Researchers also captured other survey data on disability, sleep, anxiety, and depression.

Results show after eight weeks RelieVRx participants record less pain intensity with average scores of two points lower on a 10-point scale than sham V.R. program participants. Likewise, RelieVRx participants report less pain interference after eight weeks than sham V.R. users by an average of 2.3 points on a 10-point scale. In both cases, the differences are large enough for statistical reliability. On the secondary measures, RelieVRx participants say they experience less sleep disturbance, depression, and disability than sham V.R. users. Adverse effects were reported by no more than five percent of RelieVRx or sham V.R. participants, mainly dizziness, vertigo, or nausea.

Beth Darnall, a pain specialist at Stanford University medical school and co-author of the paper who advises AppliedVR, says in a company statement released through Cision that “traditional clinical guidelines have over-relied on medications or surgical procedures, which can be costly and ineffective over the long term.” Darnall adds that the new study, “builds on our previous research at a much larger scale and demonstrates that RelieVRx can be a powerful tool in providers’ tool belts for treating people experiencing chronic low back pain.”

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