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

Trial Summary

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.

What data supports the effectiveness of the treatment Cognitive Training + Electroacupuncture for Fibromyalgia?

Research shows that both transcutaneous electrical nerve stimulation (TENS) and acupuncture can reduce pain in fibromyalgia patients. Additionally, cranial electrical stimulation has been found to improve pain, fatigue, and sleep disturbances in fibromyalgia, suggesting that similar electrical stimulation techniques may be beneficial. ^{1 2 3 4 5}

Is the combination of cognitive training and electroacupuncture safe for humans?

Research on transcutaneous electrical nerve stimulation (TENS) and electroacupuncture (EA) suggests they are generally safe for pain management in adults, with no significant safety concerns reported in the studies reviewed. ^{6 7 8 9 10}

How is the treatment of Cognitive Training + Electroacupuncture for fibromyalgia different from other treatments?

This treatment is unique because it combines cognitive training, which helps patients develop skills to manage pain, with electroacupuncture, a technique that uses electrical currents to stimulate nerves, potentially offering a novel approach to managing fibromyalgia symptoms compared to traditional methods like medication or standard physical therapy. ^{1 2 3 11 12}

What is the purpose of this trial?

This study will evaluate the impact of a novel non-pharmacological multimodal therapy, a type of approach known to improve pain outcomes and recommended by the Institute of Medicine report for chronic pain management. This study design will also allow the investigators to evaluate a neural model supporting therapeutic alliance for pain outcomes for fibromyalgia.

Research Team

Vitaly Napadow, PhD

Principal Investigator

Spaulding Rehabilitation Hospital

Eligibility Criteria

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

I have been experiencing pain for at least 6 months.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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]

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) 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]

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]

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]

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]

References

1. England 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. [2023]

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

Non-invasive brain stimulation approaches to fibromyalgia pain. [2021]

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

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

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

Effects of Wearable Transcutaneous Electrical Nerve Stimulation on Fibromyalgia: A Randomized Controlled Trial. [2022]

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

Quantitative Data for Transcutaneous Electrical Nerve Stimulation and Acupuncture Effectiveness in Treatment of Fibromyalgia Syndrome. [2020]

6. Canada pubmed.ncbi.nlm.nih.gov

Functional Magnetic Resonance Imaging Evaluation of Auricular Percutaneous Electrical Neural Field Stimulation for Fibromyalgia: Protocol for a Feasibility Study. [2021]

7. Spain pubmed.ncbi.nlm.nih.gov

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

8. 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]

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

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

10. England pubmed.ncbi.nlm.nih.gov

Different effects of transcutaneous electric nerve stimulation and electroacupuncture at ST36-ST37 on the cerebral cortex. [2018]

11. Germany pubmed.ncbi.nlm.nih.gov

Beyond physiotherapy and pharmacological treatment for fibromyalgia syndrome: tailored tACS as a new therapeutic tool. [2022]

12. Canada pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for primary fibromyalgia. [2019]