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

The Immunomodulatory Effects of Frequency Specific Microcurrent In Obese Osteoarthritic Adults

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Device: Frequency Specific Microcurrent; Device: Sham microcurrent treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Lakeland, Florida, United States, 33813
      • Robinson Family Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FSM Treatment Group; Participants receiving the 40 hertz/97 hertz alternating sharp square wave 200 uamp microcurrent treatment (machine is turned on and placed in an opaque bag to cover the screen; the machine is silent and therefore will be indistinguishable form placebo)	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.; Other Names: E275 Transcutaneous Electrical Nerve Stimulator
Placebo Comparator: Placebo Group (Sham); Participants receiving sham microcurrent treatment (machine is turned off and placed in an opaque bag to cover the screen)	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.; Other Names: E275 Transcutaneous Electrical Nerve Stimulator (Machine Off)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interleukin-6	Plasma concentration	Baseline, during the intervention (15 minutes, 30 minutes, 45 minutes), and immediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Pain	0 - 10 Pain Scale, 10 being the worst pain imaginable and 0 being no pain at all	Baseline, and immediately after the intervention
Tumor Necrosis Factor Alpha	Plasma concentration	Baseline, during the intervention (15 minutes, 30 minutes, 45 minutes), and immediately after the intervention

Collaborators and Investigators

• Sponsor: Nova Southeastern University
• Investigators: Principal Investigator: Samuel Spaiser, MS, Nova Southeastern University College of Osteopathic Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2025
• Primary Completion (Actual): March 19, 2025
• Study Completion (Actual): March 19, 2025

Study Registration Dates

• First Submitted: April 22, 2024
• First Submitted That Met QC Criteria: April 28, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: 2024-213-NSU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes