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EMG Biofeedback Treatment for Chronic Low Back Pain (BEAT-Pain)

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ClinicalTrials.gov Identifier: NCT04607460
Recruitment Status : Recruiting
First Posted : October 29, 2020
Last Update Posted : January 28, 2021
Sponsor:
Information provided by (Responsible Party):
Asimina Lazaridou, PhD, Brigham and Women's Hospital

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.

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 study, we will recruit 80 patients with CLBP (for at least 6 months but no longer than 10 years), aged 18-65 years old and with minimum score of >3 on pain visual analog scale. Patients with recent low back surgery, a comorbid chronic pain condition more painful that CLBP, a non-mechanical contributing cause for lower back pain, implanted medical devices, medical conditions known to influence quantitative sensory testing (QST) or the EMG intervention, severe psychiatric disorders will be excluded from this study. 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 8 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 8 weeks 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 8-week EMG-BF will demonstrate reductions in pain, physical functioning, sleep, pain catastrophizing, anxiety and depression.


Condition or disease Intervention/treatment Phase
Chronic Low-back Pain Device: JOGO Digital Therapeutics EMG Biofeedback Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biofeedback EMG Alternative Therapy for Chronic Low Back Pain (BEAT-Pain): A Pilot Efficacy Study
Actual Study Start Date : December 3, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
Drug Information available for: Coal Tar

Arm Intervention/treatment
Experimental: EMG-Biofeedback
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
Use of the JOGO Digital Therapeutics EMG Biofeedback device for 8 weeks

No Intervention: Treatment as usual
Participants in this group will receive no active treatment.



Primary Outcome Measures :
  1. Change in Pain intensity at 8 weeks [ Time Frame: Baseline and post-treatment assessment (8 weeks after the first treatment session) ]
    will be assessed using the 0-10-point Numerical Rating Scale (NRS) from the Brief Pain Inventory (BPI) assessing pain intensity and pain interference.


Secondary Outcome Measures :
  1. Negative affect (anxiety, depression) [ Time Frame: Baseline and post-treatment assessment (8 weeks after the first treatment session) ]
    will be assessed by the Hospital Anxiety and Depression Scale. Score range 0 and 21 for either anxiety or depression, where higher scores indicate higher anxiety or depression respectively

  2. Physical function [ Time Frame: Baseline and post-treatment assessment (8 weeks after the first treatment session) ]
    will be measured using the validated Oswestry Disability Index (ODI). Score range 0-100, where higher scores indicate greater disability/functional impairment

  3. Pain catastrophizing [ Time Frame: Baseline and post-treatment assessment (8 weeks after the first treatment session) ]
    will be assessed with the Pain Catastrophizing Scale (PCS). Score range 0-52, where higher scores indicate greater pain catastrophizing.

  4. Sleep Quality [ Time Frame: Baseline and post-treatment assessment (8 weeks after the first treatment session) ]
    will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The score can range between 0-21, the higher the score, the worse the sleep quality.

  5. Pain sensitivity in kPa (pain threshold) [ Time Frame: Baseline and post-treatment assessment (8 weeks after the first treatment session) ]
    Pressure pain threshold will be assessed using a digital pressure algometer. Unit of Measure: lbf

  6. Pain sensitivity in mmHg (pain threshold) [ Time Frame: Baseline and post-treatment assessment (8 weeks after the first treatment session) ]
    Pressure pain threshold will be assessed using a Hokanson rapid cuff inflator. Unit of Measure: mmHg



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04607460


Contacts
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Contact: Asimina Lazaridou, PhD 617-732-9578 alazaridou@bwh.harvard.edu
Contact: Myrella Paschali, MD 617-732-9718 mpaschali@bwh.harvard.edu

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Chestnut Hill, Massachusetts, United States, 02467
Contact: Asimina Lazaridou, PhD    617-732-9578    alazaridou@bwh.harvard.edu   
Contact: Myrella Paschali, MD    617-732-9718    mpaschali@bwh.harvard.edu   
Principal Investigator: Asimina Lazaridou, PhD         
Sub-Investigator: Robert R. Edwards, PhD         
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Asimina Lazaridou, PhD Brigham and Women's Hospital
Publications:
Schwartz MS, Andrasik F. Biofeedback : a practitioner's guide. Fourth edition. ed. New York: The Guilford Press; 2016.

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Responsible Party: Asimina Lazaridou, PhD, Instructor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT04607460    
Other Study ID Numbers: 2020P003158
First Posted: October 29, 2020    Key Record Dates
Last Update Posted: January 28, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plan to share IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Asimina Lazaridou, PhD, Brigham and Women's Hospital:
EMG-Biofeedback
Chronic low-back pain
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Coal Tar
Keratolytic Agents
Dermatologic Agents