Microcurrent for Fibromyalgia
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Paul Crawford
Disqualifiers: Peripheral neuropathy, Pregnancy, Severe psychological disorders, others
Stay on Your Current Meds
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.
12345Is 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.
12678How 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.
12359Eligibility 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.
+6 more
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.
+12 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MicrocurrentExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mike O'Callaghan Military Medical CenterNellis Air Force Base, NV
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Who Is Running the Clinical Trial?
Paul CrawfordLead Sponsor
References
Cranial electrical stimulation improves symptoms and functional status in individuals with fibromyalgia. [2018]To investigate the effects of microcurrent cranial electrical stimulation (CES) therapy on reducing pain and its associated symptoms in fibromyalgia (FM), we conducted a randomized, controlled, three-group (active CES device, sham device, and usual care alone [UC]), double-blind study to determine the potential benefit of CES therapy for symptom management in FM. Those individuals using the active CES device had a greater decrease in average pain (p = .023), fatigue (p = .071), and sleep disturbance (p = .001) than individuals using the sham device or those receiving usual care alone over time. Additionally, individuals using the active CES device had improved functional status versus the sham device and UC groups over time (p = .028).
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]This study investigated the efficacy of a transcutaneous electrical nerve stimulation (TENS) device (Quell®) for persons with symptoms due to fibromyalgia (FM).
Transcutaneous Electrical Nerve Stimulation Reduces Movement-Evoked Pain and Fatigue: A Randomized, Controlled Trial. [2022]Fibromyalgia (FM) is characterized by pain and fatigue, particularly during physical activity. Transcutaneous electrical nerve stimulation (TENS) activates endogenous pain inhibitory mechanisms. This study was undertaken to investigate if using TENS during activity would improve movement-evoked pain and other patient-reported outcomes in women with FM.
Effectiveness of fixed-site high-frequency transcutaneous electrical nerve stimulation in chronic pain: a large-scale, observational study. [2022]The objective of this study was to assess the effectiveness of fixed-site high-frequency transcutaneous electrical nerve stimulation (FS-TENS) in a real-world chronic pain sample.
[Analgesic effects of transcutaneous electrical nerve stimulation (TENS) in patients with fibromyalgia: A systematic review]. [2020]To determine whether transcutaneous electrical nerve stimulation (TENS) has an analgesic effect greater than placebo or other treatments in patients with fibromyalgia. Furthermore, it was intended to analyze the optimal application parameters to achieve a greater reduction of pain.
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]To investigate the efficacy and safety of transcutaneous electrical nerve stimulation (TENS) for relief of pain in adults.
The Fibromyalgia Transcutaneous Electrical Nerve Stimulation in Physical Therapy Study Protocol: A Multisite Embedded Pragmatic Trial. [2023]Transcutaneous electrical nerve stimulation (TENS) is a nonpharmacological intervention that provides an electrical current through the skin to produce analgesia. The primary purpose of this study is to examine if the addition of TENS to routine physical therapy improves movement-evoked pain in individuals with fibromyalgia in a physical therapy clinical setting.
Clinical evaluation of pain treatment with electrostimulation: a study on TENS in patients with different pain syndromes. [2019]We evaluated the clinical efficacy and the unwanted side effects of transcutaneous electrical nerve stimulation (TENS) in a consecutive group of patients with intractable pain due to different pain syndromes.
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]In Germany, there are several microcurrent medical devices that are certified for the treatment of patients suffering from one of the indications chronic back pain, skeletal system pain, fibromyalgia, migraine or depression. While certification is based on controlled, randomized clinical trials, evidence of efficacy and safety under real-world conditions is limited to very few observational studies. To fill this gap, this study was conducted.