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

NCT04607460 | Completed FDA Device

• 1 other identifier: 2020P003158
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

EMG-Biofeedback; Chronic low-back pain; Mastectomy; Lumpectomy; Migraine

Outcome Measures

Primary Outcomes (1)

• Change in Pain intensity after treatment period

  will be assessed using the 0-10-point Numerical Rating Scale (NRS) from the Brief Pain Inventory (BPI) assessing pain intensity and pain interference.

  Through study completion, an average of 6 months

Secondary Outcomes (6)

• Negative affect (anxiety, depression)

  Through study completion, an average of 6 months

• Physical function

  Through study completion, an average of 6 months

• Pain catastrophizing

  Through study completion, an average of 6 months

• Sleep Quality

  Through study completion, an average of 6 months

• Pain sensitivity in kPa (pain threshold)

  Through study completion, an average of 6 months

Study Arms (6)

EMG-Biofeedback for Lower Back Pain

EXPERIMENTAL

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.

Device: JOGO Digital Therapeutics EMG Biofeedback for Lower Back Pain

Treatment as usual (Lower Back Pain)

NO INTERVENTION

Participants in this group will receive no active treatment.

EMG-Biofeedback for Persistent Post-Mastectomy Pain

EXPERIMENTAL

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.

Device: JOGO Digital Therapeutics EMG Biofeedback for Persistent Post Mastectomy Pain

Treatment as usual (Persistent Post-Mastectomy Pain)

NO INTERVENTION

Participants in this group will receive no active treatment.

EMG-Biofeedback for Migraine

EXPERIMENTAL

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.

Device: JOGO Digital Therapeutics EMG Biofeedback for Migraine

Treatment as usual (Migraine)

NO INTERVENTION

Participants in this group will receive no active treatment.

Interventions

JOGO Digital Therapeutics EMG Biofeedback for Lower Back Pain DEVICE

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

EMG-Biofeedback for Lower Back Pain

JOGO Digital Therapeutics EMG Biofeedback for Persistent Post Mastectomy Pain DEVICE

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.

EMG-Biofeedback for Persistent Post-Mastectomy Pain

JOGO Digital Therapeutics EMG Biofeedback for Migraine DEVICE

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

EMG-Biofeedback for Migraine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, 02467, United States

Location

Related Publications (14)

• Schwartz MS, Andrasik F. Biofeedback : a practitioner's guide. Fourth edition. ed. New York: The Guilford Press; 2016.

  BACKGROUND

• Sielski R, Glombiewski JA. Biofeedback as a psychological treatment option for chronic back pain. Pain Manag. 2017 Mar;7(2):75-79. doi: 10.2217/pmt-2016-0040. Epub 2016 Nov 4. No abstract available.

  PMID: 27809657 BACKGROUND

• Jacobs JV, Henry SM, Jones SL, Hitt JR, Bunn JY. A history of low back pain associates with altered electromyographic activation patterns in response to perturbations of standing balance. J Neurophysiol. 2011 Nov;106(5):2506-14. doi: 10.1152/jn.00296.2011. Epub 2011 Jul 27.

  PMID: 21795622 BACKGROUND

• Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.

  PMID: 8080219 BACKGROUND

• Snaith RP. The hospital anxiety and depression scale. Br J Gen Pract. 1990 Jul;40(336):305. No abstract available.

  PMID: 2081070 BACKGROUND

• Sullivan MJ, Thorn B, Haythornthwaite JA, Keefe F, Martin M, Bradley LA, Lefebvre JC. Theoretical perspectives on the relation between catastrophizing and pain. Clin J Pain. 2001 Mar;17(1):52-64. doi: 10.1097/00002508-200103000-00008.

  PMID: 11289089 BACKGROUND

• Smyth C. The Pittsburgh Sleep Quality Index (PSQI). Director. 2000 Winter;8(1):28-9. No abstract available.

  PMID: 11081020 BACKGROUND

• Katz NP, Paillard FC, Edwards RR. Review of the performance of quantitative sensory testing methods to detect hyperalgesia in chronic pain patients on long-term opioids. Anesthesiology. 2015 Mar;122(3):677-85. doi: 10.1097/ALN.0000000000000530.

  PMID: 25437498 BACKGROUND

• Wasan AD, Alter BJ, Edwards RR, Argoff CE, Sehgal N, Walk D, Moeller-Bertram T, Wallace MS, Backonja M. Test-Retest and Inter-Examiner Reliability of a Novel Bedside Quantitative Sensory Testing Battery in Postherpetic Neuralgia Patients. J Pain. 2020 Jul-Aug;21(7-8):858-868. doi: 10.1016/j.jpain.2019.11.013. Epub 2019 Dec 11.

  PMID: 31837446 BACKGROUND

• Jamison RN, Jurcik DC, Edwards RR, Huang CC, Ross EL. A Pilot Comparison of a Smartphone App With or Without 2-Way Messaging Among Chronic Pain Patients: Who Benefits From a Pain App? Clin J Pain. 2017 Aug;33(8):676-686. doi: 10.1097/AJP.0000000000000455.

  PMID: 27898460 BACKGROUND

• Jamison RN, Xu X, Wan L, Edwards RR, Ross EL. Determining Pain Catastrophizing From Daily Pain App Assessment Data: Role of Computer-Based Classification. J Pain. 2019 Mar;20(3):278-287. doi: 10.1016/j.jpain.2018.09.005. Epub 2018 Sep 29.

  PMID: 30273687 BACKGROUND

• Lazaridou A, Paschali M, Vilsmark ES, Edwards RR. Biofeedback EMG alternative therapy for chronic low back pain: Study protocol of a pilot randomized controlled trial. Contemp Clin Trials. 2022 Oct;121:106888. doi: 10.1016/j.cct.2022.106888. Epub 2022 Aug 18.

  PMID: 35988661 BACKGROUND

• Lazaridou A, Paschali M, Vilsmark ES, Sadora J, Burton D, Bashara A, Edwards RR. Biofeedback EMG alternative therapy for chronic low back pain (the BEAT-pain study). Digit Health. 2023 Feb 7;9:20552076231154386. doi: 10.1177/20552076231154386. eCollection 2023 Jan-Dec.

  PMID: 36776410 RESULT

• Sadora J, Vilsmark E, Bashara A, Burton D, Paschali M, Pester B, Curiel M, Edwards R, Lazaridou A. Electromyography-biofeedback for chronic low back pain: A qualitative cohort study. Complement Ther Med. 2023 May;73:102922. doi: 10.1016/j.ctim.2023.102922. Epub 2023 Jan 28.

  PMID: 36716896 RESULT

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Asimina Lazaridou, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 29, 2020
• Study Start: December 3, 2020
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)