Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06390137
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-04-22
Brief Title:
Anti-Inflammatory Effects Of Frequency Specific Microcurrent FSM In Osteoarthritic Adults
Sponsor:
Nova Southeastern University
Organization:
Nova Southeastern University
Study Overview
Official Title:
The Immunomodulatory Effects of Frequency Specific Microcurrent In Obese Osteoarthritic Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It is hypothesized that application of frequency specific microcurrent can decrease inflammation in osteoarthritis patients resulting in decreased pain and potentially decrease disease progression Participants will received the microcurrent treatment for one hour and a total of five blood draws to measure inflammatory markers Participants will also complete a pre and post treatment pain questionnaire
Detailed Description:
After consent the participants height and weight will be measured and body mass index calculated using the Athena Health Patient Portal Next the participant will complete a pain questionnaire to capture their baseline level of pain as well as a sign a declaration stating that they have drank a quart of water in the past four hours Then the patient will have an intravenous port established in an antecubital vein
The procedure that are being done for research purposed include five intravenous port blood draws and treatment with frequency specific microcurrent
The patient will have an intravenous port established in an antecubital vein A baseline 10 mL blood sample will be taken
Randomization scheme is as follows - after the block size was determined all possible balanced combinations of assignment within the block were calculated Blocks were then randomly chosen to determine the patients assignment into the groups
An unblinded research coordinator with no other participation in the study will apply the randomization scheme example included as attachment to patients to receive either the active microcurrent treatment or a sham treatment The active treatment includes turning on a Precision Distributing CustomCARE preprogrammed to produce 40 Hz on channel A and 97 Hz on channel B with 200 µamp alternating current polarity with a sharp square wave slope and placing it in an opaque bag so neither the participant or the study investigators know whether the device is on or off The sham treatment involves not turning the device on and placing it in the same bag
The electrical pulses will be sent from the CustomCARE through four six-foot leads red green yellow and black with alligator clips attached to two wet towels dampened with tap water The participant will be seated in a comfortable chair and the leads with the wet towels will be placed against bare skin as follows the red right side and green left side leads will be attached to a single towel wrapped posteriorly around the back at the level of T10 and the yellow right side and black left side leads will be attached to a second towel and wrapped anteriorly just below the abdomen and iliac crest
The participant will be instructed to relax for the next 60 minutes 10mL of blood will be drawn from the IV port and collected in vacutainer plasma tubes before treatment and at the following timepoints during treatment 15 minutes 30 minutes 45 minutes 60 minutes After completion of the treatment the participant will complete a post-treatment pain scale questionnaire duration 1 minute Total study time per participant is two hours
The procedure that are being done for research purposed include five intravenous port blood draws and treatment with frequency specific microcurrent
The patient will have an intravenous port established in an antecubital vein A baseline 10 mL blood sample will be taken
Randomization scheme is as follows - after the block size was determined all possible balanced combinations of assignment within the block were calculated Blocks were then randomly chosen to determine the patients assignment into the groups
An unblinded research coordinator with no other participation in the study will apply the randomization scheme example included as attachment to patients to receive either the active microcurrent treatment or a sham treatment The active treatment includes turning on a Precision Distributing CustomCARE preprogrammed to produce 40 Hz on channel A and 97 Hz on channel B with 200 µamp alternating current polarity with a sharp square wave slope and placing it in an opaque bag so neither the participant or the study investigators know whether the device is on or off The sham treatment involves not turning the device on and placing it in the same bag
The electrical pulses will be sent from the CustomCARE through four six-foot leads red green yellow and black with alligator clips attached to two wet towels dampened with tap water The participant will be seated in a comfortable chair and the leads with the wet towels will be placed against bare skin as follows the red right side and green left side leads will be attached to a single towel wrapped posteriorly around the back at the level of T10 and the yellow right side and black left side leads will be attached to a second towel and wrapped anteriorly just below the abdomen and iliac crest
The participant will be instructed to relax for the next 60 minutes 10mL of blood will be drawn from the IV port and collected in vacutainer plasma tubes before treatment and at the following timepoints during treatment 15 minutes 30 minutes 45 minutes 60 minutes After completion of the treatment the participant will complete a post-treatment pain scale questionnaire duration 1 minute Total study time per participant is two hours
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None