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NCT04607460 · ClinicalTrials.gov registry record · NA
EMG Biofeedback Treatment for Chronic Low Back Pain, Cancer Pain and Migraines
A NA study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 330
- Enrollment target
NCT04607460 is a NA study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 330 participants.
The verdict
NCT04607460, a NA study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 330 participants
- Enrollment target
Study 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.
Interventions
- DEVICE JOGO Digital Therapeutics EMG Biofeedback for Lower Back Pain
- DEVICE JOGO Digital Therapeutics EMG Biofeedback for Persistent Post Mastectomy Pain
- DEVICE JOGO Digital Therapeutics EMG Biofeedback for Migraine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 330 participants |
| Start Date | 2020-12-03 |
| Est. Completion | 2023-12-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04607460
The ClinicalTrials.gov registry entry for NCT04607460 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 330 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which JOGO Digital Therapeutics EMG Biofeedback for Lower Back Pain is the first listed.
NCT04607460 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04607460 about?
NCT04607460 is a clinical study titled "EMG Biofeedback Treatment for Chronic Low Back Pain, Cancer Pain and Migraines". 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 re...
What is the current status of trial NCT04607460?
This trial is currently completed. It is a NA study. The enrollment target is 330 participants. The study started on 2020-12-03. Estimated completion is 2023-12-30.
What interventions are being tested in trial NCT04607460?
The interventions under investigation include: JOGO Digital Therapeutics EMG Biofeedback for Lower Back Pain (DEVICE), JOGO Digital Therapeutics EMG Biofeedback for Persistent Post Mastectomy Pain (DEVICE), JOGO Digital Therapeutics EMG Biofeedback for Migraine (DEVICE).
Who is sponsoring clinical trial NCT04607460?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
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