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The Effect of Pulsed Electromagnetic Field Therapy on Patients With Low Back Pain

Primary Purpose

Low Back Pain

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

MDCure

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

UBCC patient
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:

current LBP complaint of 3/10 or less on the Numerical Rating Scale
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.

Sites / Locations

University of BridgeportRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Acute/subacute; active device

Acute/subacute; sham

Chronic; active device

Chronic; sham

Arm Description

MDCure active device

MDCure sham device

MDCure active device

MDCure sham device

Outcomes

Primary Outcome Measures

Change in pain intensity

Numerical Rating Scale

Change in low back pain related disability

Oswestry Disability Index

Secondary Outcome Measures

Full Information

NCT ID

NCT03053375

First Posted

February 6, 2017

Last Updated

February 11, 2017

Sponsor

University of Bridgeport

1. Study Identification

Unique Protocol Identification Number

NCT03053375

Brief Title

The Effect of Pulsed Electromagnetic Field Therapy on Patients With Low Back Pain

Official Title

The Effect of Pulsed Electromagnetic Field Therapy on Patients With Low Back Pain

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Unknown status

Study Start Date

February 8, 2017 (Actual)

Primary Completion Date

August 30, 2017 (Anticipated)

Study Completion Date

June 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Bridgeport

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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).

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Acute/subacute; active device

Arm Type

Experimental

Arm Description

MDCure active device

Arm Title

Acute/subacute; sham

Arm Type

Placebo Comparator

Arm Description

MDCure sham device

Arm Title

Chronic; active device

Arm Type

Experimental

Arm Description

MDCure active device

Arm Title

Chronic; sham

Arm Type

Placebo Comparator

Arm Description

MDCure sham device

Intervention Type

Device

Intervention Name(s)

MDCure

Intervention Description

Battery powered portable pulsed electromagnetic therapy device

Primary Outcome Measure Information:

Title

Change in pain intensity

Description

Numerical Rating Scale

Time Frame

Baseline, weeks 6 and 12

Title

Change in low back pain related disability

Description

Oswestry Disability Index

Time Frame

Baseline, weeks 6 and 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: UBCC patient 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: current LBP complaint of 3/10 or less on the Numerical Rating Scale 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anthony J Lisi

Phone

203-576-4437

alisi@bridgeport.edu

Facility Information:

Facility Name

University of Bridgeport

City

Bridgeport

State/Province

Connecticut

ZIP/Postal Code

06604

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anthony J Lisi, DC

alisi@bridgeport.edu

Phone

203-576-4437

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

30868475

Citation

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.

Results Reference

derived

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The Effect of Pulsed Electromagnetic Field Therapy on Patients With Low Back Pain

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