Microcurrent for Fibromyalgia

Overseen By Amanda J Crawford, MSHS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Paul Crawford

Disqualifiers: Peripheral neuropathy, Pregnancy, Severe psychological disorders, others

Stay on Your Current Meds You can continue your current medications while participating

Compensation: Varies

Number of Visits: 4

Duration: 15 days

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether microcurrent therapy can reduce pain and improve the quality of life for individuals with fibromyalgia. Participants will use a device called a Microcurrent Transcutaneous Electrical Nerve Stimulator (TENS), which sends mild electrical currents through the skin, to determine its potential as an addition to regular pain management. The trial compares the effects of a real TENS device with a placebo version to assess its effectiveness. Individuals who experience widespread pain from fibromyalgia, have had symptoms for over three months, and have access to care at Nellis Air Force Base may be suitable for this study. As an unphased trial, this study offers a unique opportunity to explore innovative pain management options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that microcurrent therapy is used as an adjunct (in addition) to medical pain management, suggesting you may continue your current treatments.

What prior data suggests that microcurrent therapy is safe for fibromyalgia patients?

Studies have shown that microcurrent therapy using a Transcutaneous Electrical Nerve Stimulator (TENS) is generally safe. Research indicates it can reduce pain without causing serious side effects. In everyday use, people find microcurrent therapy effective and easy to use for various conditions.

Moderate-certainty evidence suggests that TENS can lower pain levels, especially immediately after use, and most people tolerate it well. Importantly, no reports of serious side effects have been linked to its use. TENS is also affordable and suitable for home use, making it a practical choice for many.

These findings suggest that microcurrent therapy could be a safe option for managing fibromyalgia pain. However, discussing any new treatment with a healthcare provider is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Microcurrent TENS is unique because it offers a non-drug approach to managing fibromyalgia, a condition often treated with medications like antidepressants, anticonvulsants, and pain relievers. Unlike these standard treatments, which primarily focus on managing symptoms through altering brain chemistry or blocking pain signals, microcurrent TENS uses gentle electrical impulses to stimulate the nerves, potentially reducing pain and improving function directly at the source. This method might provide relief without the side effects commonly associated with medications, making it an exciting option for those seeking alternative therapies. Researchers are particularly interested in its ability to offer effective pain management with fewer side effects and improved quality of life for patients.

What evidence suggests that microcurrent therapy could be an effective treatment for fibromyalgia?

Research has shown that microcurrent therapy can help manage fibromyalgia symptoms. In this trial, participants will receive either the Microcurrent Transcutaneous Electrical Nerve Stimulator (TENS) or a placebo version. Studies have found that TENS, a therapy using electrical currents, can reduce pain and tiredness in people with fibromyalgia, especially during activity. A detailed analysis of various studies found microcurrent therapy very effective in easing pain for fibromyalgia patients. Additionally, daily use of TENS therapy has shown promise in reducing pain in other conditions, like long-COVID. These findings suggest that microcurrent therapy could be a useful tool for managing fibromyalgia pain. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for Active Duty or DoD beneficiaries aged 18-74 with fibromyalgia, experiencing widespread pain for at least 3 months and having more than 10 tender points. Participants must have had a neck injury in the past and be able to receive care at Nellis Air Force Base.

Inclusion Criteria

You have been diagnosed with fibromyalgia according to specific guidelines from the American College of Rheumatology.

You must be able to receive medical care at Nellis Air Force Base to take part in this study.

My symptoms have lasted for at least 3 months.

Exclusion Criteria

I have nerve damage in my hands or feet.

I do not abuse alcohol or drugs, but I may use medical marijuana.

You have serious mental health problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive microcurrent or placebo treatment and self-administer at home

15 days

3 visits (in-person), daily self-administration at home

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Microcurrent Transcutaneous Electrical Nerve Stimulator (TENS)
• PLACEBO Microcurrent Transcutaneous Electrical Nerve Stimulator (TENS)

Trial Overview The study tests if microcurrent therapy using a Transcutaneous Electrical Nerve Stimulator (TENS) can reduce generalized pain and improve life quality in fibromyalgia patients compared to a placebo device.

How Is the Trial Designed?

Group I: Microcurrent Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Paul Crawford

Lead Sponsor

Trials

6

Recruited

970+

Published Research Related to This Trial

A study involving 50 patients per condition showed that microcurrent therapy significantly improved health-related quality of life for chronic back pain, skeletal system pain, fibromyalgia, migraine, and depression over a 6-month period.

The therapy was found to be safe, with only four adverse events reported, indicating that microcurrent devices can be effectively used in real-world settings for these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Observational Study to Assesses the Efficacy and Safety of Microcurrent Therapy with a Portable Device in Patients Suffering from Chronic Back Pain, Skeletal System Pain, Fibromyalgia, Migraine or Depression. Marmann, P., Wiatrek, W.[2023]

Transcutaneous electrical nerve stimulation (TENS) has been shown to significantly reduce pain in patients with fibromyalgia, with 6 out of 8 studies demonstrating this effect.

Combining TENS with therapeutic exercise appears to enhance pain relief compared to exercise alone, although the effectiveness of TENS on other factors like fatigue and quality of life remains inconclusive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Analgesic effects of transcutaneous electrical nerve stimulation (TENS) in patients with fibromyalgia: A systematic review]. Megía García, Á., Serrano-Muñoz, D., Bravo-Esteban, E., et al.[2020]

In a randomized controlled trial involving three groups (active CES device, sham device, and usual care), microcurrent cranial electrical stimulation (CES) therapy significantly reduced average pain, fatigue, and sleep disturbances in individuals with fibromyalgia, with notable p-values indicating effectiveness.

Participants using the active CES device also showed improved functional status compared to those using the sham device or receiving usual care, suggesting that CES therapy may be a beneficial treatment option for managing fibromyalgia symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cranial electrical stimulation improves symptoms and functional status in individuals with fibromyalgia. Taylor, AG., Anderson, JG., Riedel, SL., et al.[2018]

In a study of 119 participants with fibromyalgia, the use of a transcutaneous electrical nerve stimulation (TENS) device did not show significant differences in symptom relief compared to a sham treatment after three months, indicating limited overall efficacy.

However, individuals with higher hypersensitivity experienced more improvement with the active TENS treatment, suggesting that TENS may be more beneficial for certain subgroups of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Higher Pain Sensitivity Predicts Efficacy of a Wearable Transcutaneous Electrical Nerve Stimulation Device for Persons With Fibromyalgia: A Randomized Double-Blind Sham-Controlled Trial. Jamison, RN., Curran, S., Wan, L., et al.[2022]

Transcutaneous electrical nerve stimulation (TENS) was effective in reducing pain for 53% of patients with peripheral nerve damage, 75% with anginal pain from ischemic heart disease, and 69% with musculoskeletal pain, indicating its efficacy varies based on the type of pain.

While TENS had side effects in 35% of patients initially, these were generally manageable with proper guidance, highlighting the importance of support during treatment for achieving long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of pain treatment with electrostimulation: a study on TENS in patients with different pain syndromes. Meyler, WJ., de Jongste, MJ., Rolf, CA.[2019]

A study involving 713 chronic pain patients showed that fixed-site high-frequency transcutaneous electrical nerve stimulation (FS-TENS) significantly reduced pain intensity and interference with daily activities and mood after 60 days of use.

The effectiveness of FS-TENS improved with increased usage, with 57.1% of high-utilization users experiencing clinically meaningful reductions in pain interference, highlighting the importance of consistent application for optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of fixed-site high-frequency transcutaneous electrical nerve stimulation in chronic pain: a large-scale, observational study. Kong, X., Gozani, SN.[2022]

In a study involving 301 women with fibromyalgia, using active transcutaneous electrical nerve stimulation (TENS) for 2 hours daily over 4 weeks significantly reduced movement-evoked pain compared to both placebo TENS and no TENS, indicating its efficacy as a pain management tool.

Participants using active TENS also reported a notable decrease in fatigue and a higher percentage of them felt overall improvement, with no serious adverse events related to TENS, suggesting it is a safe intervention for managing fibromyalgia symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Nerve Stimulation Reduces Movement-Evoked Pain and Fatigue: A Randomized, Controlled Trial. Dailey, DL., Vance, CGT., Rakel, BA., et al.[2022]

Transcutaneous electrical nerve stimulation (TENS) significantly reduces pain intensity during or immediately after treatment compared to placebo, based on a systematic review of 381 randomized controlled trials involving over 24,500 participants.

TENS also shows lower pain intensity compared to standard pharmacological and non-pharmacological treatments, with moderate-certainty evidence indicating it is effective and generally safe, as adverse events were mild and similar to those of comparators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of transcutaneous electrical nerve stimulation (TENS) for acute and chronic pain in adults: a systematic review and meta-analysis of 381 studies (the meta-TENS study). Johnson, MI., Paley, CA., Jones, G., et al.[2022]

This study will evaluate the effectiveness of transcutaneous electrical nerve stimulation (TENS) in reducing movement-evoked pain in 600 individuals with fibromyalgia, using a randomized cluster design across multiple physical therapy clinics.

The primary outcome will measure pain reduction over 60 days, providing valuable data on TENS as a nonpharmacological treatment option for fibromyalgia, which could influence healthcare policies and future research on chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Fibromyalgia Transcutaneous Electrical Nerve Stimulation in Physical Therapy Study Protocol: A Multisite Embedded Pragmatic Trial. Post, AA., Dailey, DL., Bayman, EO., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6485914/

Transcutaneous electrical nerve stimulation (TENS) for ... One study found 10/28 participants reported pain relief of 25% or greater with TENS compared with 10/24 participants using superficial warmth (42 °C). We judged ...

2. nature.com nature.com/articles/s41598-024-78651-5

a pilot randomized clinical trial | Scientific Reports Daily TENS therapy showed potential in reducing functional interference from pain, fatigue, and gait alterations in long-COVID individuals. The ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04949100

Study Details | NCT04949100 | Microcurrent for Fibromyalgia This study is not intended to be definitive and should be considered an exploratory randomized trial to determine conditions for which microcurrent is more ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12357078/

Investigating the therapeutic efficacy of microcurrent therapy A network meta-analysis and double-blind placebo control trial on fibromyalgia patients reported MIC as highly effective at improving pain ...

5. withpower.com withpower.com/trial/phase-fibromyalgia-6-2021-9731d

Microcurrent for Fibromyalgia Research shows that using TENS can help reduce pain and fatigue in people with fibromyalgia, especially during physical activity. Another study found that a ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10712256/

Observational Study to Assesses the Efficacy and Safety of ... Microcurrent therapy has been demonstrated to be efficient and safe under real-world conditions for the treatment of each of the conditions for which the ...

7. bmjopen.bmj.com bmjopen.bmj.com/content/12/2/e051073

Efficacy and safety of transcutaneous electrical nerve ... There was moderate-certainty evidence that pain intensity is lower during or immediately after TENS compared with placebo and without serious adverse events.