Closed-Loop epidurale Rückenmarkstimulation zur Behandlung chronischen Schmerzes bei Raynaud Phänomen. Eine prospektive, monozentrische Pilotstudie.

Raynaud's phenomenon (RP) is an episodic vasospasm of the peripheral arteries that causes cyanosis, erythema, pain, paraesthesia"s, and sometimes ulceration of the fingers and/or toes. There are few reports, mostly case series, 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 (e.g., vasodilation) in this condition.

This is a prospective, single-centre pilot study to evaluate the efficacy of ECAP-controlled closed-loop SCS (Evoke® SmartSCS, Saluda Medical, Australia) in the treatment of RP. Patient outcomes such as Raynaud Severity/Condition Score, Cochin Hand Function Scale, SHAQ RP VAS, EQ-5D-5L, PGIC, stimulation parameters, and objective peripheral blood flow assessments and neurophysiological measurements were collected at baseline, trial end, 1-month, 3-months, and 6-months.

The mean age ± standard deviation (±SD) patients is 45.5±15.5 years (n=10), and 80% are female.

The mean baseline (±SEM; n=9) weekly attack frequency was 21.8±5.9 and decreased to 12.6±4.6 6-months after implantation (n=8; Figure 2A). The mean baseline (±SEM; n=9) severity of attacks was 6.7±0.4 which decreased to 3.3±0.6 6-months after implantation (n=8; Figure 2A). The mean baseline (±SEM; n=9) Raynaud's condition score was 6.6±0.7 and decreased to 2.6±0.7 6-months after implantation (n=8; Figure 2A).

The mean baseline (±SEM; n=9) cochin hand function scale score was 31.6±8.2 and decreased to 17.4±7.7 6-months after implantation (n=8; Figure 2B). The mean patient global impression of change score at 6-months after implantation was 2.3±0.4 (±SEM; n=8; Figure 2C).

In conclusion, ECAP-controlled closed-loop-SCS alleviates RP symptoms and improves peripheral blood flow.