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This trial was conducted in a prospective, multicenter, randomized withdrawal design at a designated clinical trial facility. The total sample size for this trial is expected to be 59-62 patients.
One to two subjects were conducted in each study center as a preliminary test. A total of about 3-6 subjects were selected for the pre-test. The pre-test subjects used the test equipment (on state) and were not randomized.
The study was divided into screening/baseline period, treatment period (including test period, random withdrawal period and observation period) and follow-up period.
All subjects underwent a 7-day baseline assessment (VAS score for at least 4 days) during the screening/baseline period. Eligible subjects underwent Peripheral Nerve Stimulation(PNS) surgery and implanted electrode leads and entered the 7-day test period. During the test period, subjects with an average VAS score improvement of ≥30%(VAS score for at least 4 days) will be randomly assigned to the experimental group (on state) or the control group (off state) in a 1:1 ratio for 7 days observation. All subjects were enrolled in the observation period until 28 days after implantation. Safety assessment was performed at a 14-day follow-up after removal of the device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Turn on the machine for continuous nerve stimulation |
|
| control group | No Intervention | Turn off the machine |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous peripheral nerve stimulation system | Device | All subjects underwent a 7-day baseline assessment (VAS score for at least 4 days) during the screening/baseline period. Eligible subjects underwent PNS surgery and implanted electrode leads and entered the 7-day test period. During the test period, subjects with an average VAS score improvement of ≥30%(VAS score for at least 4 days) will be randomly assigned to the experimental group (on state) or the control group (off state) in a 1:1 ratio for 7 days observation. All subjects were enrolled in the observation period until 28 days after implantation. Safety assessment was performed at a 14-day follow-up after removal of the device. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference of the mean VAS scores of the experimental group and the control group during the random withdrawal period | (VASEGbase -- VASEGwd) Average - (VASCGbase -- VASCGwd) Average Explanation: VASEGbase was the mean VAS score of subjects in the experimental group at 4 days before the random withdrawal period. VASEGwd was the maximum VAS score of subjects in the experimental group during the random withdrawal period. VASCGbase was the mean VAS score of subjects in the control group at 4 days before the random withdrawal period. The maximum VAS score of subjects in the VASCGwd control group during the random withdrawal period. | 7 days after the wire implantation test period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ke Ma, PhD | Contact | 86-21-25078707 | marke72@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ke Ma, PhD | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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