NCT03053375

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

February 8, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 15, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

February 15, 2017

Status Verified

February 1, 2017

Enrollment Period

7 months

First QC Date

February 6, 2017

Last Update Submit

February 11, 2017

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (4)

Acute/subacute; active device

EXPERIMENTAL

MDCure active device

Device: MDCure

Acute/subacute; sham

PLACEBO COMPARATOR

MDCure sham device

Device: MDCure

Chronic; active device

EXPERIMENTAL

MDCure active device

Device: MDCure

Chronic; sham

PLACEBO COMPARATOR

MDCure sham device

Device: MDCure

Interventions

MDCureDEVICE

Battery powered portable pulsed electromagnetic therapy device

Acute/subacute; active deviceAcute/subacute; shamChronic; active deviceChronic; sham

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bridgeport

Bridgeport, Connecticut, 06604, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 30868475DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Anthony J Lisi

CONTACT

203-576-4437alisi@bridgeport.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2017

First Posted

February 15, 2017

Study Start

February 8, 2017

Primary Completion

August 30, 2017

Study Completion

June 30, 2018

Last Updated

February 15, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will share

Locations

US(1)