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

Conditions

Chronic Low-back Pain Mastectomy Lumpectomy Migraine EMG-Biofeedback

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this pilot efficacy study is to examine the effects of EMG-biofeedback (EMG-BF) on pain-related outcomes in Chronic Low Back Pain (CLBP) patients, Recent mastectomy and lumpectomy patients, and patients with episodic migraine. EMG-BF facilitates neuromuscular retraining and muscle relaxation by using audio and visual stimuli using an EMG surface electrode-based biosensor and a software installed on a tablet or smart phone. For this pilot efficacy study, we will recruit 125 patients with chronic low back pain, 125 patients who are expected to undergo mastectomy and 80 patients with episodic migraine. Participants will be randomly assigned to either the JOGO Digital Therapeutics EMG Biofeedback device or treatment as usual control group. Patients assigned to the intervention group will be asked to complete self-report questionnaires assessing demographics, pain intensity, negative affect, physical function, pain catastrophizing and sleep, will undergo QST and will be asked to wear Actiwatches to keep track of health behaviors, prior to and after completing the intervention. The intervention consists of weekly sessions during which participants will be instructed on how to use the device by a trained biofeedback instructor. Patients in the control group will undergo sensory testing procedures at baseline and after treatment period but will receive no active treatment. The aims of this study are to examine the impact of EMG-BF on pain and QST and the impact of EMG-BF on psychosocial function. We hypothesize that patients that will undergo the EMG-BF will demonstrate reductions in pain, physical functioning, sleep, pain catastrophizing, anxiety and depression.

Official Title

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

Quick Facts

Study Start:2020-12-03

Study Completion:2023-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04607460

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

Asimina Lazaridou, PhD

PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, 02467

United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

Asimina Lazaridou, PhD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-03

Study Completion Date2023-12-30

Study Record Updates

Study Start Date2020-12-03

Study Completion Date2023-12-30

Terms related to this study

Keywords Provided by Researchers

EMG-Biofeedback
Chronic low-back pain
Mastectomy
Lumpectomy
Migraine

Additional Relevant MeSH Terms

Chronic Low-back Pain
Mastectomy
Lumpectomy
Migraine