Cognitive Training + Electroacupuncture for Fibromyalgia

Recruiting at 2 trial locations

Overseen By Arvina Grahl, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Spaulding Rehabilitation Hospital

Must not be taking: Opioid analgesics

Disqualifiers: Psychiatric disorders, Anxiety, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore a new non-drug approach to managing fibromyalgia pain. Participants will receive either cognitive training, which involves learning pain management techniques from a pain specialist, or education training about fibromyalgia. The study will also examine how these treatments affect the brain's response to pain. It suits individuals who have experienced moderate to severe fibromyalgia pain for at least six months and are on stable medication. As an unphased trial, this study offers a unique opportunity to contribute to innovative research and potentially enhance personal pain management strategies.

Will I have to stop taking my current medications?

No, you will not have to stop taking your current medications. Participants must be on stable doses of medication for 30 days before the study and agree not to change medications or dosages during the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that cognitive training is generally safe for people with fibromyalgia. One type, cognitive behavioral therapy, is effective and well-received by patients. Studies have found that it can reduce pain and improve quality of life without causing major side effects.

Electroacupuncture, similar to traditional acupuncture but with a small electrical current, has been compared with other fibromyalgia treatments. Research suggests it is safe and may help relieve pain. No major safety issues have been reported, though further research could provide clearer insights into its benefits.

Both treatments have a history of being well-tolerated, which is encouraging for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel combination of cognitive training and electroacupuncture for managing fibromyalgia. Unlike typical treatments, which often include medications like antidepressants or pain relievers, electroacupuncture uses targeted electrical stimulation to potentially reduce pain more effectively and naturally. Cognitive training adds another layer by helping patients develop skills to better manage their pain perception and response. This dual approach could offer a more holistic way to tackle fibromyalgia, possibly leading to improved quality of life for sufferers.

What evidence suggests that this trial's treatments could be effective for fibromyalgia?

This trial will compare Cognitive Training with Education Training for fibromyalgia. Research has shown that brain exercises, such as those used in Cognitive Training, can reduce pain and improve mood in people with fibromyalgia. Studies have found that combining these exercises with other treatments can significantly ease pain and symptoms like anxiety and depression. Cognitive behavioral therapy (CBT), a type of brain exercise, is often recommended as a primary treatment for fibromyalgia due to its effectiveness and general tolerability. Electroacupuncture, which combines acupuncture with mild electrical stimulation, may help by affecting pain pathways in the body. Early research suggests that electroacupuncture can lower pain levels and enhance overall well-being for those with fibromyalgia. ^{1 4 6 7 8}

Who Is on the Research Team?

Vitaly Napadow, PhD

Principal Investigator

Spaulding Rehabilitation Hospital

Are You a Good Fit for This Trial?

This trial is for individuals with Myofascial Pain Syndrome or Fibromyalgia who meet specific criteria, have a pain intensity of at least 4/10, and have been in pain for over six months. Participants must be on stable medication doses and agree not to change them during the study. They can't join if they work in pain treatment, have certain mental health conditions, contraindications to fMRI scans like metal implants or pacemakers, use opioids, or are pregnant.

Inclusion Criteria

Meet traditional American College of Rheumatology (ACR) criteria for FM as well as the more recent Wolfe et al 2011 criteria

My pain level is at least a 4 out of 10.

I have been experiencing pain for at least 6 months.

Exclusion Criteria

Inability to respond accurately to the pain-relieving intervention in the behavioral part of the experiment, indicating a lack of response to the expectancy manipulation. If the healthy volunteer or clinician is not a responder to the behavioral expectancy induction he or she will be excluded

Documented peripheral neuropathy

Pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cognitive Training

Participants will meet with a pain specialist who will conduct a specific form of cognitive training targeting fibromyalgia.

Up to 6 months

Education Training

Participants will meet with a pain specialist to receive education training related to fibromyalgia.

Up to 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Electroacupuncture
• Training

Trial Overview

The trial tests cognitive training combined with electroacupuncture to see if it improves brain coordination and reduces chronic pain. It's non-drug-based and follows recommendations for managing chronic pain. The study will also explore how therapeutic relationships affect pain outcomes using neural models.

How Is the Trial Designed?

Group I: Cognitive Training Experimental Treatment 2 Interventions

Participants will meet with a pain specialist who will conduct a specific form of cognitive training targeting fibromyalgia.

Group II: Education Training Active Control 2 Interventions

Participants will meet with a pain specialist to receive education training related to fibromyalgia.

Electroacupuncture is already approved in China, United States, European Union for the following indications:

Approved in China as Electroacupuncture for:

• Pain relief
• Chronic pain
• Muscle spasms
• Paralysis
• Neurological diseases

Approved in United States as Electroacupuncture for:

• Pain management
• Chronic pain disorders
• Nausea and vomiting

Approved in European Union as Electroacupuncture for:

• Pain relief
• Chronic pain
• Rheumatoid arthritis

Who Is Running the Clinical Trial?

Spaulding Rehabilitation Hospital

Lead Sponsor

Trials

143

Recruited

11,200+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

Cognitive-behavioral therapy (CBT) is effective in teaching patients skills to manage pain and disability, showing promise for individuals with primary fibromyalgia, similar to its success in back pain and rheumatoid arthritis.

The article outlines experimental designs for randomized controlled trials of CBT in fibromyalgia patients, emphasizing the need for specific methodological features to ensure robust results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for primary fibromyalgia. Bradley, LA.[2019]

Fibromyalgia is linked to central nervous system hypersensitivity and involves various genetic and environmental factors, leading to significant morbidity and high treatment costs despite existing therapies.

Emerging noninvasive brain stimulation techniques, like transcranial direct current stimulation and transcranial magnetic stimulation, show promise as potential treatments for fibromyalgia pain, but further research is necessary to establish their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive brain stimulation approaches to fibromyalgia pain. Short, B., Borckardt, JJ., George, M., et al.[2021]

Transcranial alternating current stimulation (tACS) combined with physiotherapy significantly reduced pain and improved cognitive symptoms in patients with fibromyalgia syndrome (FMS), as evidenced by clinical assessments conducted on 15 participants over a 2-week period.

EEG results showed that tACS increased alpha1 brain wave activity, which correlated with improvements in self-reported cognitive skills and neuropsychological scores, indicating that tACS may effectively modulate abnormal brain activity associated with FMS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond physiotherapy and pharmacological treatment for fibromyalgia syndrome: tailored tACS as a new therapeutic tool. Bernardi, L., Bertuccelli, M., Formaggio, E., et al.[2022]

This study investigates the effects of percutaneous electrical neural field stimulation (PENFS) on fibromyalgia symptoms in 20 adults, aiming to reduce brain connectivity between the default mode network and the insula, which may correlate with pain relief and reduced medication use.

The trial is designed as a feasibility study to assess the practicality of using functional connectivity MRI to explore the neural mechanisms of PENFS, with the goal of informing a larger clinical trial on its efficacy for improving pain and function in fibromyalgia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional Magnetic Resonance Imaging Evaluation of Auricular Percutaneous Electrical Neural Field Stimulation for Fibromyalgia: Protocol for a Feasibility Study. Gebre, M., Woodbury, A., Napadow, V., et al.[2021]

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]

In a study of 119 adults with fibromyalgia, transcutaneous electrical nerve stimulation (TENS) showed modest benefits in reducing pain and improving function, particularly in individuals with higher pain sensitivity.

While there was no overall difference in patient-reported outcomes between active and sham TENS treatments, those with higher pain sensitivity experienced significant improvements, suggesting TENS may be a safe and effective option for managing fibromyalgia symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Wearable Transcutaneous Electrical Nerve Stimulation on Fibromyalgia: A Randomized Controlled Trial. Jamison, RN., Edwards, RR., Curran, S., et al.[2022]

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]

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) 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]

This study investigates the effectiveness of eye movement desensitization and reprocessing (EMDR) therapy in reducing pain symptoms in fibromyalgia patients, particularly those with a history of psychological trauma, involving 45 participants in a double-blind randomized controlled trial.

The trial will also assess whether combining EMDR with multifocal transcranial current stimulation (MtCS) enhances pain relief, with evaluations conducted at baseline, post-treatment, and at a 6-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Augmentation of EMDR with multifocal transcranial current stimulation (MtCS) in the treatment of fibromyalgia: study protocol of a double-blind randomized controlled exploratory and pragmatic trial. Gardoki-Souto, I., Martín de la Torre, O., Hogg, B., et al.[2023]

In a study involving 20 volunteers, electroacupuncture (EA) significantly increased the amplitude of median nerve-somatosensory evoked potentials (MN-SEPs) compared to sham TENS and 2 Hz TENS, indicating a stronger cortical response.

No differences in latency were observed between the different stimulation methods, suggesting that while EA enhances signal amplitude, it does not affect the speed of nerve signal transmission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Different effects of transcutaneous electric nerve stimulation and electroacupuncture at ST36-ST37 on the cerebral cortex. Kang, YT., Liao, YS., Hsieh, CL.[2018]

In a study involving 42 fibromyalgia patients and 21 healthy volunteers, both TENS and acupuncture treatments led to significant increases in alpha brain wave activity and reductions in pain scores, indicating their therapeutic efficacy.

The findings suggest that both interventions can enhance brain activity related to pain inhibition, making them beneficial options for managing fibromyalgia syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative Data for Transcutaneous Electrical Nerve Stimulation and Acupuncture Effectiveness in Treatment of Fibromyalgia Syndrome. Yüksel, M., Ayaş, Ş., Cabıoğlu, MT., et al.[2020]

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