Efficacy of virtual reality treatment of phantom leg pain: Results of a randomized clinical trial

Approximately 90% of individuals with limb amputation experience persistent sensation of the missing extremity and up to 85% experience pain in the missing limb, (phantom limb pain; PLP). In this registered clinical trial (NCT05296265), we tested the efficacy of two Virtual Reality (VR) treatments of phantom leg pain. Adaptive randomization was used to assign 36 participants (19 transfemoral, 17 transtibial) to eight sessions of an active or distractor VR treatment. The active VR treatment required leg movements and provided virtual visual feedback. The distractor treatment was a commercial VR treatment for pain. The primary outcome measures were the comparison of pain at baseline versus immediately post-treatment and at 1-week and 8-week follow-up; pain was assessed on two measures from the McGill Pain Questionnaire. The secondary outcome measure, obtained in each session, was average pain intensity since the last treatment. Pain on both primary outcome measures was significantly reduced with moderate effect sizes for the active treatment only; effects on intensity persisted at 1-week follow-up, and effects on pain quality persisted at 8-weeks follow-up. Ratings of pain intensity since the last treatment showed a large effect size for the active treatment and was significant for both treatments. Statistical superiority of the active treatment on the primary and secondary outcomes was not established, but the active treatment showed significant effects on a numerically wider range of measures overall. This is the first clinical trial to show significant efficacy of VR treatment of PLP in a randomized sample of transfemoral and transtibial amputees.