Clinical trial NCT06390137: Anti-Inflammatory Effects Of Frequency Specific Microcurrent (FSM) In Osteoarthritic Adults
Official title: The Immunomodulatory Effects of Frequency Specific Microcurrent In Obese Osteoarthritic Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

Eligibility criteria: Inclusion Criteria:

* BMI \> 29.9
* 18 years of age or older
* active osteoarthritis diagnosis

Exclusion Criteria:

* smoker
* BMI \< 30
* have taken immune-enhancing dietary supplements or medications for inflammation in the past 10 days
* have or are currently being treated for any physician-diagnosed immune-modulating disease or disorder other than inflammatory arthritis
* received chemotherapy within the past year
* have ever received an FSM treatment with the frequency pair 40 Hz/97 Hz

Primary outcomes:
measure: Interleukin-6
timeFrame: Baseline, during the intervention (15 minutes, 30 minutes, 45 minutes), and immediately after the intervention
Secondary outcomes:
measure: Tumor Necrosis Factor Alpha
timeFrame: Baseline, during the intervention (15 minutes, 30 minutes, 45 minutes), and immediately after the intervention
measure: General Pain
timeFrame: Baseline, and immediately after the intervention
Other outcomes:
Locations:
city: Lakeland
country: United States
facility: Robinson Family Clinic
state: Florida
Study officials:
affiliation: Nova Southeastern University College of Osteopathic Medicine
name: Samuel Spaiser, MS
role: PRINCIPAL_INVESTIGATOR
References: