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

NCT06390137 | Completed FDA Device

• 1 other identifier: 2024-213-NSU
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Interleukin-6

  Plasma concentration

  Baseline, during the intervention (15 minutes, 30 minutes, 45 minutes), and immediately after the intervention

Secondary Outcomes (2)

• Tumor Necrosis Factor Alpha

  Baseline, during the intervention (15 minutes, 30 minutes, 45 minutes), and immediately after the intervention

• General Pain

  Baseline, and immediately after the intervention

Study Arms (2)

FSM Treatment Group

EXPERIMENTAL

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

Placebo Group (Sham)

PLACEBO COMPARATOR

Participants receiving sham microcurrent treatment (machine is turned off and placed in an opaque bag to cover the screen)

Device: Sham microcurrent treatment

Interventions

Frequency Specific Microcurrent DEVICE

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.

Also known as: E275 Transcutaneous Electrical Nerve Stimulator

FSM Treatment Group

Sham microcurrent treatment DEVICE

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.

Also known as: E275 Transcutaneous Electrical Nerve Stimulator (Machine Off)

Placebo Group (Sham)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Southeastern University: lead

Study Sites (1)

Robinson Family Clinic

Lakeland, Florida, 33813, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Samuel Spaiser, MS

  Nova Southeastern University College of Osteopathic Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 30, 2024
• Study Start: March 5, 2025
• Primary Completion: March 19, 2025
• Study Completion: March 19, 2025
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)