Phase 2 Randomized Clinical Trial Evaluating the Use of the Vascular Electrical Stimulation Therapy by Device Diavein in Severe Painful Vaso-occlusive Crisis of Sickle Cell Disease: Reduction of Crisis Exit Time and Hospital Stay Duration

Background

Painful Vaso-Occlusive Crisis (VOCs) remains the main reason for medical consultation and hospitalization of sickle cell patients. These crises can be life-threatening when management is delayed and significantly contribute to the heavy socio-economic burden of sickle cell disease. Various adjuvants are added to the analgesic treatment, these include Vascular Electrical Stimulation Therapy (VEST).

Objective

To assess the efficacy and safety of VEST in severe sickle cell VOCs in Lubumbashi.

Methods

Single-blind, multicenter randomized clinical trial involving 60 sickle cell patients aged 4 years and above in severe VOC (VAS ≥ 6), divided into three arms of witch 2 intervention arms using the Diavein® VEST Device (one arm with analgesics and the other with analgesics coupled with a non-steroidal anti-inflammatory drug) and one control arm. The primary outcome was crisis exit time (at least 6 hours spent at VAS ≤ 2 without recurrence within 5 days). The data was coded on Excel 2010 and analyzed on Epi Info 7 and R version 3.4.4. Appropriate descriptive statistical tests were conducted. A variance test (ANOVA) was used to compare means with P value threshold at 5%.

Results

Sixty-seven patients with similar baseline characteristics were enrolled and randomised between 12/19/2017 and 22/02/2019. With mean seizure exit times of 65.8 ± 23.9 h for the control group and 33.9 ± 21.5 h for the analgesic intervention group, 30.4 ± 21.5 h for the intervention group with analgesics and non-steroidal anti-inflammatory drugs. The VOCs were relieved rapidly in the intervention group with a statistically significant difference (p<0.001). The VEST was well tolerated.

Conclusion

VEST by Diavein®, as an adjuvant to the analgesic treatment of sickle cell VOCs, is effective and well tolerated.

Keywords

Painful vaso-occlusive crises; Vascular electrical stimulation therapy; Diavein®; Efficacy; Tolerance

Author(s): Paul Boma Muteb, Charles Matungulu, Stephanie Ngimbi Luntadila, Daniel Mwamba, Simon Kakuru Kambale, Jean-Jean Israel Wela , Abel Ntambue Mukengeshayi3 and Jules Panda Mulefu

Abstract | Full-Text | PDF

Share This Article