NCT04607460: BEAT-Pain

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

Completed NA Last updated 30 January 2026

What this trial tests

NA trial testing JOGO Digital Therapeutics EMG Biofeedback for Lower Back Pain in Chronic Low-back Pain in 330 participants. Completed in 30 December 2023.

Timeline

3 December 2020

Primary endpoint
30 December 2023

30 December 2023

Quick facts

Lead sponsor	Brigham and Women's Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	330
Start date	3 December 2020
Primary completion	30 December 2023
Estimated completion	30 December 2023
Sites	1 location across United States

Drugs / interventions tested

• JOGO Digital Therapeutics EMG Biofeedback for Lower Back Pain
• JOGO Digital Therapeutics EMG Biofeedback for Persistent Post Mastectomy Pain
• JOGO Digital Therapeutics EMG Biofeedback for Migraine

Conditions studied

• Chronic Low-back Pain — all drugs for Chronic Low-back Pain →
• Mastectomy — all drugs for Mastectomy →
• Lumpectomy — all drugs for Lumpectomy →
• Migraine — all drugs for Migraine →

Sponsor

Brigham and Women's Hospital

Who can join

Adults 18 to 65, any sex, with Chronic Low-back Pain or Mastectomy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Biofeedback EMG alternative therapy for chronic low back pain (the BEAT-pain study).
   Lazaridou A, Paschali M, Vilsmark ES, Sadora J, et al · · 2023 · cited 9× · PMID 36776410 · DOI 10.1177/20552076231154386
2. Biofeedback EMG alternative therapy for chronic low back pain: Study protocol of a pilot randomized controlled trial.
   Lazaridou A, Paschali M, Vilsmark ES, Edwards RR. · · 2022 · cited 2× · PMID 35988661 · DOI 10.1016/j.cct.2022.106888