Clinical trial · Interventional
EMG Biofeedback Treatment for Chronic Low Back Pain, Cancer Pain and Migraines
Biofeedback EMG Alternative Therapy for Chronic Low Back Pain and Chronic Cancer Pain (BEAT-Pain): A Pilot Efficacy Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Low-back Pain | — | UNRESOLVED | — |
| Lumpectomy | — | UNRESOLVED | — |
| Mastectomy | — | UNRESOLVED | — |
| Migraine | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JOGO Digital Therapeutics EMG Biofeedback for Lower Back Pain | Device | — | UNRESOLVED |
| JOGO Digital Therapeutics EMG Biofeedback for Migraine | Device | — | UNRESOLVED |
| JOGO Digital Therapeutics EMG Biofeedback for Persistent Post Mastectomy Pain | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- EMG-Biofeedback for Lower Back Pain
- description
- 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.
- interventionNames
- Device: JOGO Digital Therapeutics EMG Biofeedback for Lower Back Pain
- type
- NO_INTERVENTION
- label
- Treatment as usual (Lower Back Pain)
- description
- Participants in this group will receive no active treatment.
- type
- EXPERIMENTAL
- label
- EMG-Biofeedback for Persistent Post-Mastectomy Pain
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Low Back Pain Inclusion Criteria: * 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. Exclusion Criteria: * 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 * Significant medical abnormalities or conditions that in the opinion of the Practitioner * would interfere either with the ability to complete the study or the evaluation of the investigational device's safety and efficacy. * Recent history of a significant medical-surgical intervention that in the judgment of the * Practitioner would interfere either with the ability to complete the study or the evaluation of the investigative device's safety and efficacy. * Known allergic skin reaction to tapes and plasters. * Subject who is currently enrolled in an investigational drug or device study. Chronic Cancer Pain Inclusion criteria: * Female * Aged 18-65 years old * Recent bodily pain complaints with a minimum score of \>1 on pain visual analog scale (VAS) at the start of experimental sessions; * Scheduled for breast biopsy * Willingness to undergo psychophysical and psychosocial testing * Willingness to participate in long-term follow-up are able to speak and understand English, and (8) have access to a computer or tablet at home and have an email address. Exclusion criteria: * Pregnant * 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. * Pain condition requiring urgent surgery; * Subjects with a severe visual or hearing impairment; * 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); * Active addiction disorder, such as cocaine or IV heroin use, that would interfere with study participation, * Diagnosis of mild cognitive impairment or dementia * Significant medical abnormalities or conditions that in the opinion of the Practitioner would interfere either with the ability to complete the study or the evaluation of the investigational device's safety and efficacy. * Recent history of a significant medical-surgical intervention that in the judgment of the Practitioner would interfere either with the ability to complete the study or the evaluation of the investigative device's safety and efficacy. * Known allergic skin reaction to tapes and plasters. * Subject who is currently enrolled in an investigational drug or device study. Migraine Pain Inclusion Criteria: * Women ages 18-65 * Diagnosis of episodic migraine (with or without aura) (International Classification of Headache Disorders-II)(15) * 4-14 days with migraine in the last month * No change in the type of prophylactic and psychiatric medication used within the last 3 months * Greater than one year of migraines (self-reported) * Agreeable to participate, commit to all study procedures, and to be randomized to either group * Fluent in English (required to complete self-report instruments) Exclusion Criteria: * Any unstable medical (e.g. neurodegenerative conditions) or psychiatric conditions (e.g. psychosis) requiring immediate treatment or that could lead to difficulty complying with the protocol * Active suicidal ideation (assessed by the clinician during initial screening) * Moderate or severe level of depression (exclude if score on PHQ-2 is greater than or equal to 3) * Psychiatric hospitalization within the past year (self-reported) * Comorbid acute or chronic pain condition that is rated by the subject as more painful than migraine * Begins new migraine treatment during the study period * Inability to complete study visits * Medical condition known to influence QST or participation in the EMG intervention (e.g. HIV, peripheral neuropathy, Raynaud's syndrome); * Active addiction disorder, such as cocaine or IV heroin use, that would interfere with study participation, * Significant medical abnormalities or conditions that in the opinion of the Practitioner would interfere either with the ability to complete the study or the evaluation of the investigational device's safety and efficacy. * Recent history of a significant medical-surgical intervention that in the judgment of the Practitioner would interfere either with the ability to complete the study or the evaluation of the investigative device's safety and efficacy. * Known allergic skin reaction to tapes and plasters. * Subject who is currently enrolled in an investigational drug or device study.
References
Publications (14)
- BACKGROUNDSchwartz MS, Andrasik F. Biofeedback : a practitioner's guide. Fourth edition. ed. New York: The Guilford Press; 2016.
- BACKGROUNDSielski 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
- BACKGROUNDJacobs 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
- BACKGROUNDCleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38. PMID 8080219
- BACKGROUNDSnaith RP. The hospital anxiety and depression scale. Br J Gen Pract. 1990 Jul;40(336):305. No abstract available. PMID 2081070
- BACKGROUNDSullivan 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
- BACKGROUNDSmyth C. The Pittsburgh Sleep Quality Index (PSQI). Director. 2000 Winter;8(1):28-9. No abstract available. PMID 11081020
- BACKGROUNDKatz 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