Recruiting

Pulsed Electromagnetic Field Therapy

Sponsor:

University of Bridgeport

Code:

NCT03053375

Conditions

Low Back Pain

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

MDCure

Study Details

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).

Conditions

Low Back Pain

Study ID

NCT03053375

Start date

Feb 8, 2017

Status verified date

Feb, 2017

Completion date

Jun 30, 2018

Anticipated

Primary completion date

Aug 30, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Acute/subacute; active device

MDCure active device

placebo comparator: Acute/subacute; sham

MDCure sham device

experimental: Chronic; active device

MDCure active device

placebo comparator: Chronic; sham

MDCure sham device

Interventions

MDCure

Battery powered portable pulsed electromagnetic therapy device

Primary outcome measure

  • Change in pain intensity [ Time Frame: Baseline, weeks 6 and 12 ]
  • Change in low back pain related disability [ Time Frame: Baseline, weeks 6 and 12 ]

Central Contacts and Locations

Central contacts

Anthony J Lisi

203-576-4437alisi@bridgeport.edu

Locations

University of Bridgeport

Recruiting

Bridgeport, Connecticut, United States, 06604

Contacts

Anthony J Lisi, DC

alisi@bridgeport.edu

203-576-4437

More Information

Sponsor

University of Bridgeport

Last update posted

Feb 15, 2017

Last verified

Feb, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Bridgeport on 2017-02-15.