Low Back PainNCT03053375
The Effect of Pulsed Electromagnetic Field Therapy on Patients With Low Back Pain
A study testing MDCure in people with Low Back Pain, run by University of Bridgeport at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- MDCure
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2017to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Bridgeport
Bridgeport, Connecticut, 06604
Anthony J Lisi, DC, alisi@bridgeport.edu
203-576-4437
About this study
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).
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- MDCure
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDCureDevice
Battery powered portable pulsed electromagnetic therapy device
| Study group | Role | What they receive |
|---|---|---|
| Acute/subacute; active device | Experimental | MDCure active device Receives: Device: MDCure |
| Acute/subacute; sham | Placebo comparator | MDCure sham device Receives: Device: MDCure |
| Chronic; active device | Experimental | MDCure active device Receives: Device: MDCure |
| Chronic; sham | Placebo comparator | MDCure sham device Receives: Device: MDCure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity
Numerical Rating Scale
Measured: Baseline, weeks 6 and 12
Change in low back pain related disability
Oswestry Disability Index
Measured: Baseline, weeks 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start8 Feb 2017
- Primary completion30 Aug 2017 (estimated)
- Study completion30 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bridgeport
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03053375
- Sponsor's protocol ID
- 2015-05-03
- Status last verified
- Feb 2017
- First submitted
- 6 Feb 2017
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 30868475
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pulsed Electromagnetic Field Therapy on Patients With Low Back Pain
- ClinicalTrials.gov ID
- NCT03053375
- Acronym / sponsor ID
- 2015-05-03
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of BridgeportUniversity, hospital or other
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- 30 Aug 2017 (estimated)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 15 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Acute/subacute; active device | Experimental | Device: MDCureMDCure active device |
| Acute/subacute; sham | Placebo comparator | Device: MDCureMDCure sham device |
| Chronic; active device | Experimental | Device: MDCureMDCure active device |
| Chronic; sham | Placebo comparator | Device: MDCureMDCure sham device |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MDCureBattery powered portable pulsed electromagnetic therapy device | Device | Acute/subacute; active device, Acute/subacute; sham, Chronic; active device, Chronic; sham |
Primary outcome
Change in pain intensity
Time frame: Baseline, weeks 6 and 12
Numerical Rating Scale
Change in low back pain related disability
Time frame: Baseline, weeks 6 and 12
Oswestry Disability Index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
- Derived from this study: PubMed 30868475Lisi 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MDCure in people with Low Back Pain, run by University of Bridgeport at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anthony J Lisi (203-576-4437, alisi@bridgeport.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity (time frame: Baseline, weeks 6 and 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03053375, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2017.