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

Trial Summary

What is the purpose of this trial?

Explore the use of microcurrent therapy for fibromyalgia patients and evaluate its effect on generalized pain and quality of life. Determine if microcurrent therapy be effectively self-administered by the patient as an adjunct to medical pain management.

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 data supports the effectiveness of the treatment Microcurrent Transcutaneous Electrical Nerve Stimulator (TENS) 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 similar device, cranial electrical stimulation, improved pain, fatigue, and sleep in fibromyalgia patients. ^{1 2 3 4 5}

Is microcurrent therapy safe for humans?

Transcutaneous electrical nerve stimulation (TENS), which is similar to microcurrent therapy, has been studied in many trials and is generally considered safe for treating pain in adults, with few unwanted side effects reported. ^{1 2 6 7 8}

How does microcurrent treatment differ from other treatments for fibromyalgia?

Microcurrent treatment for fibromyalgia is unique because it uses a low-level electrical current to reduce pain and improve symptoms like fatigue and sleep disturbances. Unlike traditional medications, this therapy involves a portable device that delivers electrical stimulation, which may enhance functional status and provide relief without the side effects associated with drugs. ^{1 2 3 5 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Cranial electrical stimulation improves symptoms and functional status in individuals with fibromyalgia. [2018]

2. United States 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Nerve Stimulation Reduces Movement-Evoked Pain and Fatigue: A Randomized, Controlled Trial. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

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

5. Spain pubmed.ncbi.nlm.nih.gov

[Analgesic effects of transcutaneous electrical nerve stimulation (TENS) in patients with fibromyalgia: A systematic review]. [2020]

6. England 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). [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The Fibromyalgia Transcutaneous Electrical Nerve Stimulation in Physical Therapy Study Protocol: A Multisite Embedded Pragmatic Trial. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Clinical evaluation of pain treatment with electrostimulation: a study on TENS in patients with different pain syndromes. [2019]

9. New Zealand 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. [2023]