Cognitive Training + Electroacupuncture for Fibromyalgia
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Spaulding Rehabilitation Hospital
Must not be taking: Opioid analgesics
Disqualifiers: Psychiatric disorders, Anxiety, Pregnancy, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
678910How 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.
1231112Eligibility 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.
+2 more
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
+18 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive TrainingExperimental Treatment2 Interventions
Participants will meet with a pain specialist who will conduct a specific form of cognitive training targeting fibromyalgia.
Group II: Education TrainingActive Control2 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Spaulding Rehabilitation HospitalCharlestown, MA
Brigham and Women's HospitalChestnut Hill, MA
Massachusetts General HospitalCharlestown, MA
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Who Is Running the Clinical Trial?
Spaulding Rehabilitation HospitalLead Sponsor
National Institutes of Health (NIH)Collaborator
References
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]Fibromyalgia (FM) is a generalized, widespread chronic pain disorder affecting 2.7% of the general population. In recent years, different studies have observed a strong association between FM and psychological trauma. Therefore, a trauma-focused psychotherapy, such as eye movement desensitization and reprocessing (EMDR), combined with a non-invasive brain stimulation technique, such as multifocal transcranial current stimulation (MtCS), could be an innovative adjunctive treatment option. This double-blind randomized controlled trial (RCT) analyzes if EMDR therapy is effective in the reduction of pain symptoms in FM patients and if its potential is boosted with the addition of MtCS.
Non-invasive brain stimulation approaches to fibromyalgia pain. [2021]Fibromyalgia is a poorly understood disorder that likely involves central nervous system sensory hypersensitivity. There are a host of genetic, neuroendocrine and environmental abnormalities associated with the disease, and recent research findings suggest enhanced sensory processing, and abnormalities in central monoamines and cytokines expression in patients with fibromyalgia. The morbidity and financial costs associated with fibromyalgia are quite high despite conventional treatments with antidepressants, anticonvulsants, low-impact aerobic exercise and psychotherapy. Noninvasive brain stimulation techniques, such as transcranial direct current stimulation, transcranial magnetic stimulation, and electroconvulsive therapy are beginning to be studied as possible treatments for fibromyalgia pain. Early studies appear promising but more work is needed. Future directions in clinical care may include innovative combinations of noninvasive brain stimulation, pharmacological augmentation, and behavior therapies.
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).
Effects of Wearable Transcutaneous Electrical Nerve Stimulation on Fibromyalgia: A Randomized Controlled Trial. [2022]Fibromyalgia is a chronic condition characterized by widespread pain and interference with daily activities. The aim of this study is to assess the benefit of transcutaneous electrical nerve stimulation (TENS) for persons diagnosed with fibromyalgia.
Quantitative Data for Transcutaneous Electrical Nerve Stimulation and Acupuncture Effectiveness in Treatment of Fibromyalgia Syndrome. [2020]Aim. To evaluate the effects of acupuncture and transcutaneous electric nerve stimulation (TENS) applications on the quantitative electroencephalography (qEEG) changes and to evaluate their therapeutic effects in patients with fibromyalgia syndrome (FMS). The study included 42 patients with FMS and 21 healthy volunteers. The patients were randomly assigned to two groups (n=21 in each) to undergo either TENS or acupuncture application. In both acupuncture and TENS groups, baseline electroencephalography (EEG) recording was performed for 10 min and, then, TENS or acupuncture was performed for 20 min, followed by another 10 min EEG recording. Baseline qEEG findings of FMS patients in the TENS and acupuncture groups were similar. Delta and theta powers over the frontal region of FMS patients were lower than controls. Theta powers of right posterior region were also lower than controls. In the TENS group, after the treatment, an increase was observed in the alpha power of the left anterior region as well as a decrease in pain scores. In the acupuncture group, an increase was determined in the alpha power of the right and left posterior regions as well as a decrease in pain score after the treatment. The power of low- and moderate-frequency waves on resting EEG was decreased in the patients with FMS. Decreased pain and increased inhibitor activity were found on qEEG after TENS and acupuncture applications. In conclusion, both TENS and acupuncture applications seem to be beneficial in FMS patients.
Functional Magnetic Resonance Imaging Evaluation of Auricular Percutaneous Electrical Neural Field Stimulation for Fibromyalgia: Protocol for a Feasibility Study. [2021]Fibromyalgia is a chronic pain state that includes widespread musculoskeletal pain, fatigue, psychiatric symptoms, cognitive and sleep disturbances, and multiple somatic symptoms. Current therapies are often insufficient or come with significant risks, and while there is an increasing demand for non-pharmacologic and especially non-opioid pain management such as that offered through complementary and alternative medicine therapies, there is currently insufficient evidence to recommend these therapies. Percutaneous electrical neural stimulation (PENS) is an evidence-based treatment option for pain conditions that involves electrical current stimulation through needles inserted into the skin. Percutaneous electrical neural field stimulation (PENFS) of the auricle is similar to PENS, but instead of targeting a single neurovascular bundle, PENFS stimulates the entire ear, covering all auricular branches of the cranial nerves, including the vagus nerve. The neural mechanisms of PENFS for fibromyalgia symptom relief are unknown.
[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.
Different effects of transcutaneous electric nerve stimulation and electroacupuncture at ST36-ST37 on the cerebral cortex. [2018]The effects of transcutaneous electric nerve stimulation (TENS) and electroacupuncture (EA) on the cerebral cortex are largely unclear. The purpose of the present study was to investigate the effect of TENS and EA on the cerebral cortex by examining their effect on the median nerve-somatosensory evoked potentials (MN-SEPs).
Beyond physiotherapy and pharmacological treatment for fibromyalgia syndrome: tailored tACS as a new therapeutic tool. [2022]Fibromyalgia syndrome (FMS) is a complex pain disorder, characterized by diffuse pain and cognitive disturbances. Abnormal cortical oscillatory activity may be a promising biomarker, encouraging non-invasive neurostimulation techniques as a treatment. We aimed to modulate abnormal slow cortical oscillations by delivering transcranial alternating current stimulation (tACS) and physiotherapy to reduce pain and cognitive symptoms. This was a double-blinded, randomized, crossover trial conducted between February and September 2018 at the Rehabilitation Unit of a teaching Hospital (NCT03221413). Participants were randomly assigned to tACS or random noise stimulation (RNS), 5 days/week for 2 weeks followed by ad hoc physiotherapy. Clinical and cognitive assessments were performed at T0 (baseline), T1 (after stimulation), T2 (1 month after stimulation). Electroencephalogram (EEG) spectral topographies recorded from 15 participants confirmed slow-rhythm prevalence and provided tACS tailored stimulation parameters and electrode sites. Following tACS, EEG alpha1 ([8-10] Hz) activity increased at T1 (p = 0.024) compared to RNS, pain symptoms assessed by Visual Analog Scale decreased at T1 (T1 vs T0 p = 0.010), self-reported cognitive skills and neuropsychological scores improved both at T1 and T2 (Patient-Reported Outcomes in Cognitive Impairment, T0-T2, p = 0.024; Everyday memory questionnaire, T1 compared to RNS, p = 0.012; Montréal Cognitive Assessment, T0 vs T1, p = 0.048 and T0 vs T2, p = 0.009; Trail Making Test B T0-T2, p = 0.034). Psychopathological scales and other neuropsychological scores (Trail Making Test-A; Total Phonemic Fluency; Hopkins Verbal Learning Test-Revised; Rey-Osterrieth Complex Figure) improved both after tACS and RNS but earlier improvements (T1) were registered only after tACS. These results support tACS coupled with physiotherapy in treating FMS cognitive symptoms, pain and subclinical psychopathology.
Cognitive-behavioral therapy for primary fibromyalgia. [2019]The purpose of cognitive-behavioral therapy is to teach individuals the skills necessary to control pain and disability as well as to believe that they can successfully employ these skills. Cognitive-behavioral therapy has been used successfully in patients with back pain and rheumatoid arthritis and represents a potentially effective intervention for patients with primary fibromyalgia. This article describes cognitive-behavioral treatment procedures, presents 2 experimental designs that may be used in randomized, controlled clinical trials of cognitive-behavioral therapy in patients with primary fibromyalgia and identifies the methodological features that should be included in the trials.