A Prospective Single-center Pilot Study on the Use of Closed-loop Spinal Cord Stimulation to Treat Chronic Pain Associated With Raynaud's Phenomenon.

OBJECTIVES

Raynaud's phenomenon (RP) is a vascular disorder characterized by episodic peripheral artery vasospasms, resulting in paleness, cyanosis, and/or erythema. There are few reports, mostly case reports, on the benefits of spinal cord stimulation (SCS) for the treatment of RP. However, there is a lack of objective evidence on SCS-induced modulation of the sympathetic system (eg, vasodilation) in this condition. We hypothesize that evoked compound action potential-controlled closed-loop SCS may relieve pain, reduce the severity and frequency of Raynaud attacks, and improve peripheral blood flow.

MATERIALS AND METHODS

This prospective, observational, single-center pilot study aimed to evaluate the effectiveness of SCS in treating primary and secondary RP. Patient outcomes such as pain, Raynaud severity/condition score, Cochin Hand Function Scale, Scleroderma Health Assessment Questionnaire RP visual analog scale, EQ-5D-5L, Patient Global Impression of Change, blood flow assessments, and neurophysiological measurements were collected at baseline, trial end, one month, three months, and six months.

RESULTS

Ten patients were successfully enrolled in the study and underwent epidural electrode placement for SCS. SCS resulted in a significant improvement in the severity of RP attacks (severity difference from baseline at trial end: -1.8, 95% CI, -3.1 to -0.5; p = 0.01; at one month: -2.1; 95% CI, -3.4 to -0.8; p = 0.004; at three months: -2.9; 95% CI, -4.2 to -1.6; p = 0.0002) and Raynaud condition score (difference from baseline at trial end: -2.1; 95% CI, -3.3 to -0.9; p = 0.002; at one month: -2.2; 95% CI, -3.4 to -1.0; p = 0.002; at three months: -3.3; 95% CI, -4.6 to -2.1; p = 0.00002; at six months: -4.1; 95% CI, -5.4 to -2.8; p = 0.0000008), and an objective reduction in peripheral occlusion and ulceration. While one of the combined primary end points was successfully achieved in terms of severity at the three-month follow-up, it is worth noting that the primary end point related to frequency improvement was not met during the same time frame.

CONCLUSIONS

This pilot study offers evidence linking SCS with the activation of large, myelinated fibers within the dorsal column in patients with RP. This activation is associated with improvement in the number of patient-related outcomes and enhanced peripheral circulation.

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