EMG biofeedback for managing chronic pain and migraines

Biofeedback EMG Alternative Therapy for Chronic Low Back Pain and Chronic Cancer Pain (BEAT-Pain): A Pilot Efficacy Study

This study is testing if using an EMG biofeedback device can help people with chronic low back pain, those recovering from breast surgery, and individuals with migraines feel less pain and improve their physical function compared to standard treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 330 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Brigham and Women's Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Chestnut Hill, Massachusetts)
• Trial ID: NCT04607460 on ClinicalTrials.gov

What this trial studies

This pilot efficacy study investigates the impact of EMG biofeedback on pain outcomes in patients suffering from chronic low back pain, those recovering from mastectomy or lumpectomy, and individuals experiencing episodic migraines. Participants will be randomly assigned to receive either the JOGO Digital Therapeutics EMG Biofeedback device or standard treatment. The study aims to assess various pain-related metrics, including pain intensity and physical function, through self-report questionnaires and quantitative sensory testing. The goal is to determine the effectiveness of this biofeedback approach in alleviating pain symptoms.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-65 with chronic low back pain lasting between 6 months and 10 years, or those recovering from mastectomy or lumpectomy, and individuals with episodic migraines.

Not a fit: Patients with recent lower back surgery, severe comorbid pain conditions, or those currently undergoing active cancer treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide patients with a non-invasive method to manage and reduce their chronic pain.

How similar studies have performed: Previous studies on biofeedback for chronic pain have shown mixed results, indicating that while some approaches have been effective, the overall effectiveness remains uncertain.

Eligibility criteria

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.

Where this trial is running

Chestnut Hill, Massachusetts

• Brigham and Women's Hospital — Chestnut Hill, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Asimina Lazaridou, PhD — Brigham and Women's Hospital
• Study coordinator: Asimina Lazaridou, PhD

Conditions Chronic Low-back Pain; Mastectomy; Lumpectomy; Migraine; EMG-Biofeedback; Chronic low-back pain