Scrambler Therapy for Chronic Pain after Burns and Its Effect on the Cerebral Pain Network: A Prospective, Double-Blinded, Randomized Controlled Trial

Seung Yeol Lee, Chang-Hyun Park, Yoon Soo Cho, Laurie Kim, Ji Won Yoo, So Young Joo, Cheong Hoon Seo, Seung Yeol Lee, Chang-Hyun Park, Yoon Soo Cho, Laurie Kim, Ji Won Yoo, So Young Joo, Cheong Hoon Seo

Abstract

Chronic pain is common after burn injuries, and post-burn neuropathic pain is the most important complication that is difficult to treat. Scrambler therapy (ST) is a non-invasive modality that uses patient-specific electrocutaneous nerve stimulation and is an effective treatment for many chronic pain disorders. This study used magnetic resonance imaging (MRI) to evaluate the pain network-related mechanisms that underlie the clinical effect of ST in patients with chronic burn-related pain. This prospective, double-blinded, randomized controlled trial (ClinicalTrials.gov: NCT03865693) enrolled 43 patients who were experiencing chronic neuropathic pain after unilateral burn injuries. The patients had moderate or greater chronic pain (a visual analogue scale (VAS) score of ≥5), despite treatment using gabapentin and other physical modalities, and were randomized 1:1 to receive real or sham ST sessions. The ST was performed using the MC5-A Calmare device for ten 45 min sessions (Monday to Friday for 2 weeks). Baseline and post-treatment parameters were evaluated subjectively using the VAS score for pain and the Hamilton Depression Rating Scale; MRI was performed to identify objective central nervous system changes by measuring the cerebral blood volume (CBV). After 10 ST sessions (two weeks), the treatment group exhibited a significant reduction in pain relative to the sham group. Furthermore, relative to the pre-ST findings, the post-ST MRI evaluations revealed significantly decreased CBV in the orbito-frontal gyrus, middle frontal gyrus, superior frontal gyrus, and gyrus rectus. In addition, the CBV was increased in the precentral gyrus and postcentral gyrus of the hemisphere associated with the burned limb in the ST group, as compared with the CBV of the sham group. Thus, a clinical effect from ST on burn pain was observed after 2 weeks, and a potential mechanism for the treatment effect was identified. These findings suggest that ST may be an alternative strategy for managing chronic pain in burn patients.

Keywords: burn; cerebral pain network; chronic pain; scrambler therapy.

Conflict of interest statement

The authors declare that there are no potential conflict of interest.

Figures

Figure 1
Figure 1
Pain scrambler therapy on scar pain site in burn patients.
Figure 2
Figure 2
Mapping of CBV status after ST versus CBV status before ST as adjusted for sex and age. The brain regions marked in blue are regions with decreased activation after ST treatment in the ST group. A, anterior; P, posterior; L, left; R, right; I, Inferior; S, Superior.
Figure 3
Figure 3
Mapping of the CBV states in the experimental group versus the sham group. The brain regions (the precentral gyrus and postcentral gyrus) marked in red are regions with increased activation after treatment in the ST group compared to the Sham group. A, anterior; P, posterior; L, left; R, right.

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