OsteoarthritisNCT06390137
Anti-Inflammatory Effects Of Frequency Specific Microcurrent (FSM) In Osteoarthritic Adults
A study testing Frequency Specific Microcurrent in people with Osteoarthritis, run by Nova Southeastern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Frequency Specific Microcurrent
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2025to 19 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI > 29.9
- 18 years of age or older
- active osteoarthritis diagnosis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Frequency Specific Microcurrent, Sham microcurrent treatment
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frequency Specific MicrocurrentDevice
Also called E275 Transcutaneous Electrical Nerve Stimulator
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.
Sham microcurrent treatmentDevice
Also called E275 Transcutaneous Electrical Nerve Stimulator (Machine Off)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Device: Sham microcurrent treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin-6
Plasma concentration
Measured: Baseline, during the intervention (15 minutes, 30 minutes, 45 minutes), and immediately after the intervention
Secondary outcomes (2)
Tumor Necrosis Factor Alpha
Plasma concentration
Measured: Baseline, during the intervention (15 minutes, 30 minutes, 45 minutes), and immediately after the intervention
General Pain
0 - 10 Pain Scale, 10 being the worst pain imaginable and 0 being no pain at all
Measured: Baseline, and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start5 Mar 2025
- Primary completion19 Mar 2025
- Study completion19 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Spaiser, Nova Southeastern University
- Investigators
- Samuel Spaiser, MS, Principal investigator, Nova Southeastern University College of Osteopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06390137
- Sponsor's protocol ID
- 2024-213-NSU
- Status last verified
- Jun 2026
- First submitted
- 22 Apr 2024
- Last updated
- 18 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immunomodulatory Effects of Frequency Specific Microcurrent In Obese Osteoarthritic Adults
- ClinicalTrials.gov ID
- NCT06390137
- Acronym / sponsor ID
- 2024-213-NSU
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- 19 Mar 2025 (actual)
- Study completion
- 19 Mar 2025 (actual)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FSM Treatment Group | Experimental | Device: Frequency Specific MicrocurrentParticipants 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) |
| Placebo Group (Sham) | Placebo comparator | Device: Sham microcurrent treatmentParticipants receiving sham microcurrent treatment (machine is turned off and placed in an opaque bag to cover the screen) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI > 29.9
- 18 years of age or older
- active osteoarthritis diagnosis
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frequency Specific MicrocurrentAlso: E275 Transcutaneous Electrical Nerve StimulatorThe 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 | FSM Treatment Group |
| Sham microcurrent treatmentAlso: E275 Transcutaneous Electrical Nerve Stimulator (Machine Off)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. | Device | Placebo Group (Sham) |
Primary outcome
Interleukin-6
Time frame: Baseline, during the intervention (15 minutes, 30 minutes, 45 minutes), and immediately after the intervention
Plasma concentration
2 secondary outcomes
Tumor Necrosis Factor Alpha
Time frame: Baseline, during the intervention (15 minutes, 30 minutes, 45 minutes), and immediately after the intervention
General Pain
Time frame: Baseline, and immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Spaiser, MS principal investigator
Nova Southeastern University College of Osteopathic Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frequency Specific Microcurrent in people with Osteoarthritis, run by Nova Southeastern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interleukin-6 (time frame: Baseline, during the intervention (15 minutes, 30 minutes, 45 minutes), and immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.