What side effects are associated with this type of intervention?

Common treatments for chronic lower back pain, such as EMG-Biofeedback, physical therapy, and manual therapy, generally have minimal side effects. EMG-Biofeedback, which involves neuromuscular retraining and muscle relaxation through audio and visual stimuli, is typically well-tolerated, though some patients may experience temporary discomfort or muscle soreness. Physical therapy and manual therapy can also cause temporary increases in pain or soreness, particularly after initial sessions. More invasive treatments like prolotherapy may lead to temporary increases in back pain and stiffness, and botulinum toxin injections can cause pain relief that diminishes after a few months, with potential for repeated injections to be necessary.

What prior FDA approvals exist?

The FDA has approved various treatments for Chronic Lower Back Pain, including pharmacologic options like nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, and certain antidepressants. While specific FDA approvals for EMG-Biofeedback devices for CLBP are not detailed, biofeedback as a broader category has shown moderate evidence of benefit in pain management. Other non-pharmacologic treatments, such as physical therapy and exercise programs, are also commonly recommended for CLBP management.

What other types of research exist?

Promising, novel alternatives to EMG-Biofeedback for Chronic Lower Back Pain patients include: 1) Cognitive Behavioral Therapy (CBT) for pain management and reduction, 2) Mind-Body Stress Reduction (MBSR) techniques, 3) Alternative movement therapies such as Tai Chi and Yoga, 4) Multidisciplinary pain management programs, and 5) Machine-learning models to predict pharmacologic response and tailor treatments.

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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

No Placebo-Only Group

Summary

This trial is testing a device that helps people relax their muscles. It targets patients with chronic low back pain, those undergoing mastectomy or lumpectomy, and those with episodic migraines. The goal is to see if this device can help reduce their pain and improve their overall well-being.

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.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Pain intensity after treatment period

Secondary study objectives

Negative affect (anxiety, depression)

Pain catastrophizing

Pain sensitivity in kPa (pain threshold)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Chronic Lower Back Pain (CLBP) include EMG-Biofeedback, cognitive-behavioral therapy (CBT), mindfulness-based stress reduction (MBSR), and various exercise therapies. EMG-Biofeedback works by facilitating neuromuscular retraining and muscle relaxation through audio and visual stimuli, helping patients gain control over muscle tension and reduce pain. CBT helps patients manage pain by changing negative thought patterns and behaviors, leading to reduced distress and improved coping strategies. MBSR focuses on mindfulness and meditation techniques to reduce stress and enhance pain management. Exercise therapies, including core stabilization and directional preference exercises, improve physical function and reduce pain by strengthening muscles and promoting proper movement patterns. These treatments are important for CLBP patients as they offer non-pharmacological options that address both the physical and psychological components of chronic pain, leading to better overall pain management and quality of life.

The use of EMG feedback and progressive relaxation in the treatment of a woman with chronic back pain.Effectiveness of CAM therapy: understanding the evidence.Effects of electromyography biofeedback-assisted relaxation on pain in patients with advanced cancer in a palliative care unit.

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Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,666 Previous Clinical Trials

11,839,905 Total Patients Enrolled

Asimina Lazaridou, PhD5.01 ReviewsPrincipal Investigator - Brigham and Women's Hospital

Brigham and Women's Hospital

1 Previous Clinical Trials

135 Total Patients Enrolled

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.