Trials / Completed
CompletedNCT05322798
High-frequency SCS in Treatment of Chronic Limb-Threatening Ischemia
High-frequency Spinal Cord Stimulation in Treatment of Chronic Limb-Threatening Ischemia (HEAL-SCS): a Randomized Clinical Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation · Network
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study of high-frequency spinal cord stimulation (SCS) efficacy in the treatment of chronic limb-threatening ischemia (CLTI)
Detailed description
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | High-frequency SCS | Continous high-frequency stimulation (frequency - 1kHz, pulse width - 30 µs). |
| PROCEDURE | Low-frequency SCS | Continuous conventional stimulation (frequency - 30-60 Hz, pulse width - 250-500 µs). |
Timeline
- Start date
- 2018-08-12
- Primary completion
- 2020-05-30
- Completion
- 2021-05-30
- First posted
- 2022-04-12
- Last updated
- 2022-04-12
Locations
1 site across 1 country: Russia
Source: ClinicalTrials.gov record NCT05322798. Inclusion in this directory is not an endorsement.