The Effect of Pulsed Electromagnetic Field Therapy on Patients With Low Back Pain
NCT ID: NCT03053375
Last Updated: 2017-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2017-02-08
2018-06-30
Brief Summary
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Detailed Description
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The investigators will recruit patients with LBP from the University of Bridgeport chiropractic clinic, and will enroll 80 total subjects: 40 with acute or subacute LBP, and 40 with chronic LBP. Within each of those populations the investigators will assign 20 subjects to receive usual care + PEMF, and 20 to receive usual care + sham. The investigators will track any other treatments initiated or discontinued during the trial.
Patients who agree to participate with be randomly given a functional PEMF device or a sham unit. Patients and clinicians will be blinded to the assignment. All subjects will be given the same instructions for daily use of the devices, and will continue to receive usual follow-up at the UBCC clinic as indicated. The investigators will collect patient-reported measures of pain and function pain at baseline, 6 weeks, and 12 weeks, and will collect data on adverse effects at each visit and at 6 and 12 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Acute/subacute; active device
MDCure active device
MDCure
Battery powered portable pulsed electromagnetic therapy device
Acute/subacute; sham
MDCure sham device
MDCure
Battery powered portable pulsed electromagnetic therapy device
Chronic; active device
MDCure active device
MDCure
Battery powered portable pulsed electromagnetic therapy device
Chronic; sham
MDCure sham device
MDCure
Battery powered portable pulsed electromagnetic therapy device
Interventions
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MDCure
Battery powered portable pulsed electromagnetic therapy device
Eligibility Criteria
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Inclusion Criteria
* complaint of LBP intensity 4/10 or greater on the Numerical Rating Scale
* diagnosis of a mechanical LBP condition
* age 18-70 years
* fluency in written and spoken English
* for female subjects, be postmenopausal, surgically sterile, abstinent, or agree to practice an effective method of birth control for the duration of the study if sexually active
* a willingness to participate in the study as evidenced by a signed informed consent form
Exclusion Criteria
* diagnosis or suspicion of LBP caused by cancer, infection, referred visceral pain, inflammatory arthropathy, or other non-mechanical process
* current or planned pregnancy
* any electrically-based implanted devices such as pacemakers defibrillators, spinal cord stimulators, insulin pumps; metallic implants (e.g. surgical fusion constructs, disc replacements) in the low back
* status post any lumbosacral spine surgery; significant mental health co-morbidities such as severe depression, schizoaffective disorders, suicidal ideation
* inability to understand and/or complete all components of the informed consent process without the assistance of another person (e.g. without proxy)
* inability to adhere to and comply with the treatment protocol.
18 Years
70 Years
ALL
No
Sponsors
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University of Bridgeport
OTHER
Responsible Party
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Locations
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University of Bridgeport
Bridgeport, Connecticut, United States
Countries
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Central Contacts
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Facility Contacts
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Role: backup
References
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Lisi AJ, Scheinowitz M, Saporito R, Onorato A. A Pulsed Electromagnetic Field Therapy Device for Non-Specific Low Back Pain: A Pilot Randomized Controlled Trial. Pain Ther. 2019 Jun;8(1):133-140. doi: 10.1007/s40122-019-0119-z. Epub 2019 Mar 12.
Other Identifiers
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2015-05-03
Identifier Type: -
Identifier Source: org_study_id
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