Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06626854
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
Treating Chronic Knee Pain with Noninvasive Peripheral Nerve Stimulation Using Novel Interferential RadioFrequencies
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Randomized Study to Assess the Safety and Efficacy of the Novel Noninvasive Hypersound Neuromodulation System in the Treatment of Patients with Chronic Pain of Peripheral Nerve Origin
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
First the subject will undergo screening and provide informed consent Baseline measurements are then taken The subject remains seated with back support throughout the session The technician verifies and marks the knee for treatment and wraps an antenna applicator strap around the lower leg near the knee The device is turned on in test mode to confirm the therapy location with the subject identifying when they feel a sensation over their pain area The power threshold for this sensation is recorded The therapy which lasts 15 minutes is delivered at 90 of this threshold to ensure the subject does not feel it After therapy post-treatment measurements are taken
Detailed Description:
1 Subject will perform screening and informed consent
2 Baseline measurements will be taken
3 Subject will sit in chair with back support throughout duration of the session
4 Knee for treatment will be verified and marked
5 Technician will wrap antenna applicator strap around the lower leg at the knee
6 Device is turned on and set to test mode to verify therapy location Subject will verify when they feel a sensation covering their existing chronic knee pain The power threshold for sensation is recorded
7 Therapy begins and lasts for 15 minutes power threshold is set to 90 so that the subject does not feel the therapy
8 At the end of 15 minutes post-therapy measurements are recorded
2 Baseline measurements will be taken
3 Subject will sit in chair with back support throughout duration of the session
4 Knee for treatment will be verified and marked
5 Technician will wrap antenna applicator strap around the lower leg at the knee
6 Device is turned on and set to test mode to verify therapy location Subject will verify when they feel a sensation covering their existing chronic knee pain The power threshold for sensation is recorded
7 Therapy begins and lasts for 15 minutes power threshold is set to 90 so that the subject does not feel the therapy
8 At the end of 15 minutes post-therapy measurements are recorded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None