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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HF-SCS | Experimental | SCS system implantation with high-frequency stimulation availability |
|
| LF-SCS | Active Comparator | Conventional SCS system implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-frequency SCS | Procedure | Continous high-frequency stimulation (frequency - 1kHz, pulse width - 30 µs). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual analog scale (VAS) score | score by visual analog scale (0-10) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analog scale (VAS) score | score by visual analog scale (0-10) | 3 months |
| Walking Impairment Questionnaire (WIQ) - calf pain severity | walking impairment questionnaire score for calf pain severity (0-100) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kiril Orlov, MD, PhD | Meshalkin National Medical Research Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meshalkin National Medical Research Center | Novosibirsk | 630055 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36617410 | Derived | Kilchukov M, Kiselev R, Gorbatykh A, Klinkova A, Murtazin V, Kamenskaya O, Orlov K. High-Frequency versus Low-Frequency Spinal Cord Stimulation in Treatment of Chronic Limb-Threatening Ischemia: Short-Term Results of a Randomized Trial. Stereotact Funct Neurosurg. 2023;101(1):1-11. doi: 10.1159/000527309. Epub 2023 Jan 6. |
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| ID | Term |
|---|---|
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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| Low-frequency SCS | Procedure | Continuous conventional stimulation (frequency - 30-60 Hz, pulse width - 250-500 µs). |
|
| 3 months |
| Walking Impairment Questionnaire (WIQ) - calf pain severity | walking impairment questionnaire score for calf pain severity (0-100) | 12 months |
| Walking Impairment Questionnaire (WIQ) - walking distance | walking impairment questionnaire score for walking distance (0-100) | 3 months |
| Walking Impairment Questionnaire (WIQ) - walking distance | walking impairment questionnaire score for walking distance (0-100) | 12 months |
| Walking Impairment Questionnaire (WIQ) - walking speed | walking impairment questionnaire score for walking speed (0-100) | 3 months |
| Walking Impairment Questionnaire (WIQ) - walking speed | walking impairment questionnaire score for walking speed (0-100) | 12 months |
| Walking Impairment Questionnaire (WIQ) - stair climbing | walking impairment questionnaire score for stair climbing (0-100) | 3 months |
| Walking Impairment Questionnaire (WIQ) - stair climbing | walking impairment questionnaire score for stair climbing (0-100) | 12 months |
| Short form 36 health survey (SF-36) - physical component summary | quality of life by physical component summary of short form 36 health survey (0-100) | 3 months |
| Short form 36 health survey (SF-36) - physical component summary | quality of life by physical component summary of short form 36 health survey (0-100) | 12 months |
| SF-36 - mental component summary | quality of life by mental component summary of short form 36 health survey (0-100) | 3 months |
| SF-36 - mental component summary | quality of life by mental component summary of short form 36 health survey (0-100) | 12 months |
| TcPO2 (rest) | transcutaneous oxygen tension at rest | 12 months |
| TcPO2 (orthostatic probe) | transcutaneous oxygen tension during active orthostatic probe | 12 months |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |