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Mind over muscle: new biofeedback gadget targets chronic pain

NCT ID NCT04607460

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

330 people

The number who actually took part.

Started

Dec 2020

Finished

Dec 2023

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

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

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

  • Brigham and Women's Hospital

    Chestnut Hill, Massachusetts, 02467, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.