High-frequency SCS in Treatment of Chronic Limb-Threatening Ischemia

Meshalkin Research Institute of Pathology of Circulation25 enrolled

Overview

The study of high-frequency spinal cord stimulation (SCS) efficacy in the treatment of chronic limb-threatening ischemia (CLTI)

Open-label, parallel-group, randomized study with a 1:1 allocation ratio to check the hypothesis of whether high-frequency-SCS (HF-SCS) is better than conventional low-frequency (LF-SCS) for pain relief in patients with chronic limb-threatening ischemia (CLTI).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Limb-Threatening Ischemia

Interventions

High-frequency SCSPROCEDURE

Continous high-frequency stimulation (frequency - 1kHz, pulse width - 30 µs).

Low-frequency SCSPROCEDURE

Continuous conventional stimulation (frequency - 30-60 Hz, pulse width - 250-500 µs).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * non-reconstructable critical limb-threatening ischemia (CLTI) * Fontaine stage IIB-IV * VAS score 5/10 or more * succesful SCS trial Exclusion Criteria: * intractable acute infection * allergy to SCS component * ulcerations larger than 3 cm2 * inadequate patient compliance * life expectancy less than 12 months * patient refuse to participate in any stage of the study

Locations (1)

Meshalkin National Medical Research Center

Novosibirsk, Russia

Outcomes

Primary Outcomes

Visual analog scale (VAS) score

score by visual analog scale (0-10)

Time frame: 12 months

Secondary Outcomes

Visual analog scale (VAS) score

score by visual analog scale (0-10)

Time frame: 3 months

Walking Impairment Questionnaire (WIQ) - calf pain severity

walking impairment questionnaire score for calf pain severity (0-100)

Time frame: 3 months

Walking Impairment Questionnaire (WIQ) - calf pain severity

walking impairment questionnaire score for calf pain severity (0-100)

Time frame: 12 months

Walking Impairment Questionnaire (WIQ) - walking distance

walking impairment questionnaire score for walking distance (0-100)

Time frame: 3 months

Walking Impairment Questionnaire (WIQ) - walking distance

walking impairment questionnaire score for walking distance (0-100)

Time frame: 12 months

Walking Impairment Questionnaire (WIQ) - walking speed

walking impairment questionnaire score for walking speed (0-100)

Time frame: 3 months

Walking Impairment Questionnaire (WIQ) - walking speed

walking impairment questionnaire score for walking speed (0-100)

Time frame: 12 months

Data from ClinicalTrials.gov

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