EMG Biofeedback Treatment for Chronic Low Back Pain, Cancer Pain and Migraines (NCT04607460) | Clinical Trial Compass
CompletedNot Applicable
EMG Biofeedback Treatment for Chronic Low Back Pain, Cancer Pain and Migraines
United States330 participantsStarted 2020-12-03
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 cocai…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Pain intensity after treatment period
Timeframe: Through study completion, an average of 6 months