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Behavioural Intervention
EMG Biofeedback for Chronic Pain (BEAT-Pain Trial)
N/A
Recruiting
Led By Asimina Lazaridou, PhD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 6 months
Awards & highlights
BEAT-Pain Trial Summary
This trial will test whether EMG-biofeedback can help manage pain for people with chronic low back pain, recent mastectomy or lumpectomy patients, and people with episodic migraines.
Who is the study for?
This trial is for English-speaking adults aged 18-65 with chronic low back pain, recent mastectomy or lumpectomy patients, and those with episodic migraines. Participants must have access to a computer or tablet, not be pregnant, and should not have had any changes in certain medications recently. They cannot have serious psychiatric conditions, active addiction disorders, implanted medical devices affecting the spine or nerves, severe sensory impairments, unstable medical conditions that could affect participation or require urgent surgery.Check my eligibility
What is being tested?
The study tests EMG biofeedback (EMG-BF) using JOGO Digital Therapeutics devices on pain outcomes for people with chronic low back pain, post-mastectomy/lumpectomy pain and migraines. It involves weekly sessions where participants learn to use the device aimed at muscle relaxation and neuromuscular retraining. The control group receives no active treatment but undergoes baseline testing.See study design
What are the potential side effects?
Since this trial uses non-invasive biofeedback therapy through a device connected to a smartphone or tablet rather than medication or invasive procedures, side effects are minimal but may include skin irritation from electrode placement and potential frustration if difficulties arise while learning to use the technology.
BEAT-Pain Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Pain intensity after treatment period
Secondary outcome measures
Negative affect (anxiety, depression)
Pain catastrophizing
Pain sensitivity in kPa (pain threshold)
+3 moreBEAT-Pain Trial Design
6Treatment groups
Experimental Treatment
Active Control
Group I: EMG-Biofeedback for Persistent Post-Mastectomy PainExperimental Treatment1 Intervention
Participants will receive a JOGO Digital Therapeutics EMG Biofeedback device and a software installed on a tablet or smart phone. During the 4 weekly sessions participants will be instructed on how to use the device by a trained biofeedback instructor ahead of their mastectomy.
Group II: EMG-Biofeedback for MigraineExperimental Treatment1 Intervention
Participants will receive a JOGO Digital Therapeutics EMG Biofeedback device and a software installed on a tablet or smart phone. During the 6 weekly sessions participants will be instructed on how to use the device by a trained biofeedback instructor.
Group III: EMG-Biofeedback for Lower Back PainExperimental Treatment1 Intervention
Participants will receive a JOGO Digital Therapeutics EMG Biofeedback device and a software installed on a tablet or smart phone. During the 8 weekly sessions participants will be instructed on how to use the device by a trained biofeedback instructor.
Group IV: Treatment as usual (Lower Back Pain)Active Control1 Intervention
Participants in this group will receive no active treatment.
Group V: Treatment as usual (Migraine)Active Control1 Intervention
Participants in this group will receive no active treatment.
Group VI: Treatment as usual (Persistent Post-Mastectomy Pain)Active Control1 Intervention
Participants in this group will receive no active treatment.
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Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,608 Previous Clinical Trials
11,469,547 Total Patients Enrolled
Asimina Lazaridou, PhD5.01 ReviewsPrincipal Investigator - Brigham and Women's Hospital
Brigham and Women's Hospital
5Patient Review
Dr. Mina was very kind and easy to talk to. She was also clearly very experienced in the field of pain psychology, and was able to provide me with helpful strategies and tools that I could use to manage my chronic pain. Overall, she helped me to feel more confident and hopeful, and I am very grateful to her for that.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a severe mental health condition like schizophrenia, delusional disorder, or psychotic disorder that has required hospitalization in the past year and could affect your ability to take part in the study.You have had an allergic skin reaction to tapes and plasters in the past.You are between 18 and 65 years old.You have another ongoing pain condition that you find more painful than chronic lower back pain.Your lower back pain is caused by something other than a physical injury, like a tumor, infection, or inflammation.You are currently receiving treatment for cancer such as chemotherapy or radiation.You have a serious problem with your vision or hearing.You have a medical device implanted in your body, such as a spinal cord stimulator or nerve stimulator.You have been diagnosed with mild memory problems or dementia.You have thoughts about hurting yourself and the doctor knows about it.You have moderate or severe depression, or you scored 3 or higher on the PHQ-2 questionnaire.You have been hospitalized for a mental health condition in the past year, as reported by yourself.You have a painful condition that you feel is worse than migraine.You start a new treatment for migraines during the study.You have a medical condition that affects your ability to feel pain or take part in the EMG treatment. For example, HIV, peripheral neuropathy, or Raynaud's syndrome.You have had ongoing low back pain for at least 6 months but not longer than 10 years.Your pain level is higher than 3 on a pain scale at the beginning of the sessions.You have had significant pain in your body recently, rated as more than 1 on a pain scale.Women between 18 and 65 years old.You have been diagnosed with episodic migraine, with or without aura, according to specific medical guidelines.You have had migraines for 4 to 14 days in the last month.You have experienced migraines for more than a year, based on your own reports.You had surgery on your lower back in the last year.You have a painful condition that needs immediate surgery.You are currently addicted to drugs like cocaine or heroin that could make it hard for you to take part in the study.
Research Study Groups:
This trial has the following groups:- Group 1: EMG-Biofeedback for Lower Back Pain
- Group 2: Treatment as usual (Lower Back Pain)
- Group 3: EMG-Biofeedback for Persistent Post-Mastectomy Pain
- Group 4: EMG-Biofeedback for Migraine
- Group 5: Treatment as usual (Migraine)
- Group 6: Treatment as usual (Persistent Post-Mastectomy Pain)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the paramount goals of this medical trial?
"The primary evaluation criterion employed in this clinical trial is the Change in Pain intensity after a treatment period, which will be observed at Baseline and 8 weeks post-treatment. Secondary evaluations include Physical function (assessed via Oswestry Disability Index; 0-100 scale), Pain catastrophizing (Pain Catastrophizing Scale; 0-52 scale) and Pressure pain threshold (Hokanson rapid cuff inflator; mmHg)."
Answered by AI
How many individuals are partaking in this particular research endeavor?
"Affirmative. Clinicaltrials.gov has confirmed that this experiment, which was first published on December 3rd 2020 and modified most recently on April 11th 2022, is still recruiting participants from a single site with the goal of enrolling 330 individuals."
Answered by AI
Are there any open enrollment opportunities for this trial?
"Affirmative. According to clinicaltrials.gov, this research is currently recruiting volunteers; it was initially published on December 3rd 2020 and was last updated on April 11th 2022. 330 patients need to be enrolled from a single site for the trial to commence."
Answered by AI
Do I qualify for participation in this medical research endeavor?
"This trial is actively recruiting 330 individuals aged 18-65 with a history of migraine. The following requirements must be met for eligibility: Low Back pain, Age between 18 and 65; chronic pain documented in medical records no more than 10 years ago; minimum VAS score higher than 3 prior to the experiment's commencement; fluency in English language, access to personal computing device and active email account."
Answered by AI
Does this medical research accept participants aged 65 and above?
"To be eligible for this research project, individuals must fall between the age of majority and 65 years."
Answered by AI
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