NCT06390137

Anti-Inflammatory Effects Of Frequency Specific Microcurrent (FSM) In Osteoarthritic Adults

The Immunomodulatory Effects of Frequency Specific Microcurrent In Obese Osteoarthritic Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Nova Southeastern University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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 participant's 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.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Frequency Specific Microcurrent	The participant will receive an FSM treatment of 40 Hz on channel A and 97 Hz on channel B at 200 uamp with alternating current with a sharp square wave slope for 60 minutes with body contact points using 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 TENS unit will be wrapped in an opaque bag so that the device is indistinguishable from that of the sham treatment.
DEVICE	Sham microcurrent treatment	The participant will receive a sham FSM treatment with the machine off wrapped in an opaque bag for 60 minutes with body contact points using 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.

Timeline

• Start date: 2025-03-05
• Primary completion: 2025-03-19
• Completion: 2025-03-19
• First posted: 2024-04-30
• Last updated: 2025-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study