Stereotactic and Functional Neurosurgery

Kilchukov M.a· Kiselev R.a· Gorbatykh A.a· Klinkova A.b· Murtazin V.a· Kamenskaya O.b· Orlov K.a,c

Author affiliations

aDepartment of Neurosurgery, E. Meshalkin National Medical Research Centre of the Ministry of Health of the Russian Federation, Novosibirsk, Russian Federation
bDepartment of Physiology, E. Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation, Novosibirsk, Russian Federation
cEndovascular Neurosurgery Research Center, Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency of Russia, Moscow, Russian Federation

Stereotact Funct Neurosurg

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Article / Publication Details

First-Page Preview

Received: June 08, 2022
Accepted: August 15, 2022
Published online: January 06, 2023

Number of Print Pages: 11
Number of Figures: 4
Number of Tables: 4

ISSN: 1011-6125 (Print)
eISSN: 1423-0372 (Online)

For additional information: https://www.karger.com/SFN

Abstract

Introduction: The objective of the study is to determine if high-frequency (1 kHz) spinal cord stimulation (SCS) is better than low-frequency SCS for pain relief in chronic limb-threatening ischemia (CLTI). Methods: HEAL-SCS trial was designed as an open-label, parallel-group, single-center randomized study with a 1:1 allocation ratio. The trial was conducted in Meshalkin National Medical Research Center between August 2018 and February 2020. Total 56 patients underwent screening, 50 were enrolled, 6 were rejected. The participants were randomized into 2 cohorts of 25 patients each by an external coordinator using an online tool. A neurosurgeon and a vascular surgeon both examined all patients and estimated the pain intensity using visual analog scale (VAS), quality of life with short-form-36 health survey (SF-36), and functional status by walking impairment questionnaire (WIQ) at 3 and 12 months. Tissue perfusion was evaluated for 34 patients using transcutaneous oxygen tension measurement (TcPO2) at baseline and in 12 months. Results: All 50 patients (84% men, median age 66.5 y.o) were available for primary outcome assessment 3 and 12 months after implantation. Intention-to-treat analysis demonstrated comparative advantage of HF-SCS over LF-SCS at 3 months with mean VAS score 2.8 (95% CI, 2.4; 3.2) and 3.3 (95% CI, 3.0; 3.6), respectively (p = 0.031). Clinical superiority of HF-SCS persisted at 12-month follow-up (p < 0.001). HF-SCS produced significantly greater pain relief by WIQ at 3 (p < 0.001) and 12 months (p = 0.009). Despite stair-climbing ability was better in HF-SCS group (p = 0.02), no significant difference between groups was found at 1-year post-op in terms of speed (p = 0.92) and distance scores (p = 0.68). Accordingly, the general and mental health domains of SF-36 were significantly better in HF-SCS at 12 months. Despite a tendency toward better resting oxygen pressure in HF-SCS group, there was no intergroup difference by TcPO2 (p = 0.076). Only 1 patient (2%) required above-the-knee amputation at 10 months after LF-SCS implantation. Conclusion: High-frequency SCS provides better pain relief, life quality, and functional performance in patients with CLTI during short-term follow-up. The lack of perfusion difference between high-frequency and conventional SCS requires further examination to the possible long-term advantages of the method.

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First-Page Preview

Received: June 08, 2022
Accepted: August 15, 2022
Published online: January 06, 2023

Number of Print Pages: 11
Number of Figures: 4
Number of Tables: 4

ISSN: 1011-6125 (Print)
eISSN: 1423-0372 (Online)

For additional information: https://www.karger.com/SFN

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