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

Summary

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.

Conditions

• Chronic Low-back Pain
• Mastectomy
• Lumpectomy
• Migraine

Interventions

DEVICE

JOGO Digital Therapeutics EMG Biofeedback for Lower Back Pain

Use of the JOGO Digital Therapeutics EMG Biofeedback device for 8 weeks with specific exercises to target low back pain.

DEVICE

JOGO Digital Therapeutics EMG Biofeedback for Persistent Post Mastectomy Pain

Use of the JOGO Digital Therapeutics EMG Biofeedback device for 4 weeks with specific exercises to mitigate persistent post mastectomy pain ahead of the surgery.

DEVICE

JOGO Digital Therapeutics EMG Biofeedback for Migraine

Use of the JOGO Digital Therapeutics EMG Biofeedback device for 6 weeks with specific exercises to target migraine pain.

Sponsors & Collaborators

• Brigham and Women's Hospital

  lead OTHER

Principal Investigators

• Asimina Lazaridou, PhD · Brigham and Women's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-03

Primary Completion

2023-12-30

Completion

2023-12-30

FDA Device

Yes

Countries

• United States

Study Locations