A Study to Confirm the Safety of High Frequency DRG Stimulator in Patients With Chronic Lower Limb Pain
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|ClinicalTrials.gov Identifier: NCT03285113|
Recruitment Status : Completed
First Posted : September 15, 2017
Results First Posted : January 22, 2021
Last Update Posted : January 22, 2021
|Condition or disease||Intervention/treatment||Phase|
|Failed Back Surgery Syndrome Complex Regional Pain Syndrome (CRPS)||Device: GiMer Medical MN 1000 External Stimulator||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-arm, Open Label, Single Center Pilot Study to Confirm the Safety of Dorsal Root Ganglia (DRG) and Ultrahigh Frequency Spinal Cord Stimulator in Patients With Chronic Lower Limb Pain|
|Actual Study Start Date :||March 3, 2017|
|Actual Primary Completion Date :||February 5, 2018|
|Actual Study Completion Date :||February 5, 2018|
Experimental: Ultrahigh Frequency Stimulation
Patients with chronic lower limb pain will be treated with ultrahigh frequency stimulation via lead around DRG.
Device: GiMer Medical MN 1000 External Stimulator
Trial stimulator to generate pulsed ultrahigh frequency (>200KHz) electrical stimulation, delivered via lead around DRG, in treating pain. Similar with current market available Spinal Cord Stimulators but with a higher stimulation frequency (hundred KHz) range.
- Safety of Ultrahigh Frequency Treatment: Adverse Event (AE) and Serious AE (SAE) [ Time Frame: 5 days ]Number of Participants with Adverse Events and Serious Adverse Events
- Change in Pain Measured by Visual Analog Scale (VAS) [ Time Frame: 4 days ]VAS: 0 (no pain) to 10 (max pain). Change in pain as a result of ultrahigh frequency DRG stimulation, as measured by VAS score compare to baseline VAS.
- Incidence of Paresthesia [ Time Frame: 2 days ]If patients feel tingling during stimulation?
- Change in Pain Medication Consumption [ Time Frame: 5 days ]Decrease in pain medication consumption, including Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and weak opioids, compared to baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03285113
|China Medical University Hospital|