EMG Biofeedback Treatment for Chronic Low Back Pain, Cancer Pain and Migraines

Prior treatment

• Lower back surgery within previous twelve (12) months;
• would interfere either with the ability to complete the study or the evaluation of the investigational device's safety and efficacy.
• Subject who is currently enrolled in an investigational drug or device study.
  • Chronic Cancer Pain
• 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.
• Subject who is currently enrolled in an investigational drug or device study.
  • Migraine Pain
• 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.
• Subject who is currently enrolled in an investigational drug or device study.

Other illness

• Comorbid chronic pain condition that is rated by the subject as more painful than CLBP
• Pain condition requiring urgent surgery;
• 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);
• 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
• Diagnosis of mild cognitive impairment or dementia
• Significant medical abnormalities or conditions that in the opinion of the Practitioner
• Recent history of a significant medical-surgical intervention that in the judgment of the
• Known allergic skin reaction to tapes and plasters.
• 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;
• 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
• 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.
• 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
• 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
• 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,
• 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.

Other

• Females who are pregnant;
• Implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator);
• study participation,
• Practitioner would interfere either with the ability to complete the study or the evaluation of the investigative device's safety and efficacy.
• Pregnant
• Implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator);
• 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)
• Begins new migraine treatment during the study period
• Inability to complete study visits

• 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.
• 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.
• 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)

Criteria the registry did not label

• Low Back Pain