Home-based virtual reality for chronic pain: protocol for an NIH-supported randomised-controlled trial.

Area of Science:

• Digital therapeutics and pain management.
• Investigating virtual reality (VR) as a non-pharmacological intervention for chronic pain.
• Exploring novel treatments for chronic lower back pain (cLBP).

Background:

• Chronic pain, particularly cLBP, presents a significant health burden.
• There is a need for safe, home-based, non-pharmacological pain management strategies.
• Virtual reality (VR) shows promise for acute pain, but its efficacy in chronic pain requires further study.

Purpose of the Study:

• To evaluate the effectiveness of three distinct VR interventions for patients with cLBP.
• To assess VR's potential as a safe and accessible home-based treatment for chronic pain.
• To identify predictors of VR efficacy in managing cLBP.

Main Methods:

• A randomized trial involving 360 patients with cLBP.
• Comparison of skills-based VR, distraction-based VR, and sham VR interventions over 12 weeks.
• Outcomes measured via patient-reported data (REDCap), wearable sensors (Fitbit), and electronic health records.

Main Results:

• Primary outcome: NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scale.
• Secondary outcomes include PROMIS Anxiety, PROMIS Sleep Disturbance, and opioid prescription data.
• Subgroup analyses will examine patient-level predictors of VR effectiveness.

Conclusions:

• The NIH BACPAC VR trial protocol is established to rigorously evaluate VR for cLBP.
• Findings will contribute to understanding VR's role in non-pharmacological chronic pain management.
• Results will be disseminated via peer-reviewed publication.