Mind over muscle: new biofeedback gadget targets chronic pain
NCT ID NCT04607460
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a device that uses muscle sensors and a phone app to teach people how to relax tense muscles. It included 330 adults with chronic low back pain, recent breast surgery pain, or migraines. Half used the device plus usual care; the other half had only usual care. The goal was to see if the device lowers pain and improves sleep and mood.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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330 people
The number who actually took part.
- Started
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Dec 2020
- Finished
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Dec 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Low Back Pain Inclusion Criteria: * Age 18-65 years old; * Chronic Low Back Pain as seen on medical history for at least 6 months but no longer than 10 years; * A minimum score of \>3 on pain visual analog scale (VAS) at the start of experimental sessions; * are able to speak and understand English, and (6) have access to a computer or tablet at home and have an email address. Exclusion Criteria: * Lower back surgery within previous twelve (12) months; * Comorbid chronic pain condition that is rated by the subject as more painful than CLBP * Pain condition requiring urgent surgery; * Females who are pregnant; * Subjects with a severe visual or hearing impairment; * Evidence of non-mechanical contributing cause for lower back pain e.g. neoplasm, infection, fracture, inflammatory disorder incl. acute osteomyelitis or acute bone disease; * Subjects currently under active cancer treatment (chemo, infusion, ongoing radiation); * Implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator); * Medical condition known to influence QST or participation in the EMG intervention * (e.g. HIV, peripheral neuropathy, Raynaud's syndrome); * Present or past serious psychiatric condition (e.g. Schizophrenia, delusional disorder, * psychotic disorder, or dissociative disorder) or any psychiatric condition that required hospitalization the past year and that would be judged to interfere with study participation. * Active addiction disorder, such as cocaine or IV heroin use, that would interfere with * study participation, * Diagnosis of mild cognitive impairment or dementia * Significant medical abnormalities or conditions that in the opinion of the Practitioner * would interfere either with the ability to complete the study or the evaluation of the investigational device's safety and efficacy. * Recent history of a significant medical-surgical intervention that in the judgment of the * Practitioner would interfere either with the ability to complete the study or the evaluation of the investigative device's safety and efficacy. * Known allergic skin reaction to tapes and plasters. * Subject who is currently enrolled in an investigational drug or device study. Chronic Cancer Pain Inclusion criteria: * Female * Aged 18-65 years old * Recent bodily pain complaints with a minimum score of \>1 on pain visual analog scale (VAS) at the start of experimental sessions; * Scheduled for breast biopsy * Willingness to undergo psychophysical and psychosocial testing * Willingness to participate in long-term follow-up are able to speak and understand English, and (8) have access to a computer or tablet at home and have an email address. Exclusion criteria: * Pregnant * Present or past serious psychiatric condition (e.g. Schizophrenia, delusional disorder, psychotic disorder, or dissociative disorder) or any psychiatric condition that required hospitalization the past year and that would be judged to interfere with study participation. * Pain condition requiring urgent surgery; * Subjects with a severe visual or hearing impairment; * Implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator); * Medical condition known to influence QST or participation in the EMG intervention (e.g. HIV, peripheral neuropathy, Raynaud's syndrome); * Active addiction disorder, such as cocaine or IV heroin use, that would interfere with study participation, * Diagnosis of mild cognitive impairment or dementia * Significant medical abnormalities or conditions that in the opinion of the Practitioner would interfere either with the ability to complete the study or the evaluation of the investigational device's safety and efficacy. * Recent history of a significant medical-surgical intervention that in the judgment of the Practitioner would interfere either with the ability to complete the study or the evaluation of the investigative device's safety and efficacy. * Known allergic skin reaction to tapes and plasters. * Subject who is currently enrolled in an investigational drug or device study. Migraine Pain Inclusion Criteria: * Women ages 18-65 * Diagnosis of episodic migraine (with or without aura) (International Classification of Headache Disorders-II)(15) * 4-14 days with migraine in the last month * No change in the type of prophylactic and psychiatric medication used within the last 3 months * Greater than one year of migraines (self-reported) * Agreeable to participate, commit to all study procedures, and to be randomized to either group * Fluent in English (required to complete self-report instruments) Exclusion Criteria: * Any unstable medical (e.g. neurodegenerative conditions) or psychiatric conditions (e.g. psychosis) requiring immediate treatment or that could lead to difficulty complying with the protocol * Active suicidal ideation (assessed by the clinician during initial screening) * Moderate or severe level of depression (exclude if score on PHQ-2 is greater than or equal to 3) * Psychiatric hospitalization within the past year (self-reported) * Comorbid acute or chronic pain condition that is rated by the subject as more painful than migraine * Begins new migraine treatment during the study period * Inability to complete study visits * Medical condition known to influence QST or participation in the EMG intervention (e.g. HIV, peripheral neuropathy, Raynaud's syndrome); * Active addiction disorder, such as cocaine or IV heroin use, that would interfere with study participation, * Significant medical abnormalities or conditions that in the opinion of the Practitioner would interfere either with the ability to complete the study or the evaluation of the investigational device's safety and efficacy. * Recent history of a significant medical-surgical intervention that in the judgment of the Practitioner would interfere either with the ability to complete the study or the evaluation of the investigative device's safety and efficacy. * Known allergic skin reaction to tapes and plasters. * Subject who is currently enrolled in an investigational drug or device study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Brigham and Women's Hospital
Chestnut Hill, Massachusetts, 02467, United States
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