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This study will examine the effects of a portable of pulsed electromagnetic field (PEMF) device (MD Cure, Aerotel, USA) compared with a sham device on patient-reported outcomes of pain and function in patients with either acute/subacute or chronic low back pain (LBP).
This study is a double-blind, placebo-controlled, randomized pilot study comparing usual care + PEMF with usual care + sham.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute/subacute; active device | Experimental | MDCure active device |
|
| Acute/subacute; sham | Placebo Comparator | MDCure sham device |
|
| Chronic; active device | Experimental | MDCure active device |
|
| Chronic; sham | Placebo Comparator | MDCure sham device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MDCure | Device | Battery powered portable pulsed electromagnetic therapy device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain intensity | Numerical Rating Scale | Baseline, weeks 6 and 12 |
| Change in low back pain related disability | Oswestry Disability Index | Baseline, weeks 6 and 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anthony J Lisi | Contact | 203-576-4437 | alisi@bridgeport.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Bridgeport | Recruiting | Bridgeport | Connecticut | 06604 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30868475 | Derived | 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. |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |