NCT00325377

Brief Summary

The purpose of this study is to test whether or not the Magnetic Molecular Energizer (MME) device provides a well tolerated and effective intervention to reduce pain, pain-related symptoms and improve ability to function in those diagnosed with the condition "Chronic Low Back Pain" (chronic 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
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2006

Geographic Reach
1 country

5 active sites

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

Study Start

First participant enrolled

April 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2006

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

July 10, 2007

Status Verified

July 1, 2007

First QC Date

May 10, 2006

Last Update Submit

July 8, 2007

Conditions

Chronic Low Back Pain

Keywords

low back painpainmagnetismelectromagnetic fieldsvisual analogue pain scale

Outcome Measures

Primary Outcomes (2)

  • reduction in pain

  • improved ability to function

Secondary Outcomes (3)

  • tolerability to procedure

  • neurologic stability

  • reduction in pain medication

Interventions

MME ProcedurePROCEDURE

Eligibility Criteria

Age30 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • daily low back pain of at least 3 months duration
  • stable neurologic status
  • prior medical work up and trial of standard medical therapy

You may not qualify if:

  • progressive neurologic deficits
  • neurologic deficits in the legs due to a medical condition other than the back
  • severe obesity (BMI \> 34.9)
  • long acting narcotics
  • severe spinal stenosis (fixed obstruction of the spinal canal)
  • pacemakers, defibrillators, implanted medication pump, spinal cord stimulator or shrapnel
  • low back screws, rods, artificial discs or cages
  • fibromyalgia
  • pregnancy
  • an open insurance claim or pending legal claim or settlement related to the back pain, or retired on back-related disability, or receiving disability pension related to the back problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

AMRI Arizona

Tucson, Arizona, 85711, United States

Location

AMRI Michegan

Sterling Heights, Michigan, 48313, United States

Location

AMRI North Carolina

Mocksville, North Carolina, 27208, United States

Location

AMRI NW Ohio

Toledo, Ohio, 43606, United States

Location

AMRI WA

Renton, Washington, 98055, United States

Location

MeSH Terms

Conditions

Low Back PainPain

Condition Hierarchy (Ancestors)

Back PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Wayne R Bonlie, M.D.

    AMRI International

    STUDY DIRECTOR

  • Dean R Bonlie, DDS

    AMRI International

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 10, 2006

First Posted

May 12, 2006

Study Start

April 1, 2006

Study Completion

January 1, 2008

Last Updated

July 10, 2007

Record last verified: 2007-07

Locations

US(5)