Percutaneous Neuromodulation Therapy (PNT) With Chronic Low Back Pain Patients

May 8, 2009 updated by: RS Medical

Percutaneous Neuromodulation Therapy With Chronic Low Back Pain Patients With or Without Lower Extremity Pain - A Randomized, Controlled, Parallel Groups Study

The purpose of this study is to assess the benefits of Percutaneous Neuromodulation Therapy when compared to a reference sham treatment in the treatment of patients who have undergone surgical intervention for chronic low back pain with or without a radiating lower extremity pain component.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • UCSD Pain Research Center
    • Georgia
      • Atlanta, Georgia, United States, 03027
        • Center for Prospective Outcome Studies
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Mossberg Research Group
      • Medford, Oregon, United States, 97504
        • Pain Specialists of Southern Oregon
    • Tennessee
      • Knoxville, Tennessee, United States, 37922
        • Neuropsychiatric Pain Medicine Association of Tennessee
      • Seymour, Tennessee, United States, 37865
        • Physical Medicine & Rehabilitation Center
    • Texas
      • Denton, Texas, United States, 76208
        • Texas Back Institute - Denton
      • Plano, Texas, United States, 75093
        • Texas Back Institute CRO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Low back pain for at least 6 months
  • If lower extremity pain present, must be present for at least 3 months
  • Visual analog scale (VAS) score for low back pain at least 50 out of 100
  • Lumbar or lumbosacral surgical intervention without pain relief
  • Central sensitization symptoms
  • Agrees to follow randomized treatment plan
  • 18 years of age or older
  • Signed informed consent form

Exclusion Criteria:

  • Significant change to low back or lower extremity pain within 4 weeks prior to enrollment
  • Nociceptive and/or neuropathic pain symptoms in the spine due to structural and/or mechanical instabilities
  • Three or more lumbar or lumbosacral surgical interventions; one or more surgical interventions in areas other than lumbar or lumbosacral spine
  • Three or more lumbar vertebral segments fused
  • Lumbar or lumbosacral surgical intervention in last 9 months; areas other than lumbar or lumbosacral in last 12 months
  • Any additional surgical intervention required 3 months post-enrollment
  • Symptoms consistent with sympathetically-maintained pain
  • Evidence of serious neurological deficits or impairments
  • Significant changes in pain medications within 4 weeks prior to enrollment
  • Psychosocial issues that conflict with valid reporting by patient
  • Prior treatment with percutaneous electrical stimulation or sensitivity to electrical stimulation
  • Current use of another electrical stimulation device for low back or lower extremity pain
  • Current enrollment in another clinical trial within the last 30 days
  • Current or prior malignancy or cancer
  • Serious or uncontrolled systemic illness
  • Body mass index (BMI) greater than 40
  • Pregnant or intends to become pregnant during the study
  • Implanted medical device
  • Relationship with study staff
  • Unable to attend study office visits or complete study measures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PNT
Device: Vertis Percutaneous Neuromodulation Therapy (PNT)
  • Ten PNT sessions in eleven weeks
  • On average, one PNT session per week
  • Ten lumbar Safeguide electrodes (three centimeters in length) deployed per lumbar montage
  • Forty-five minutes of electrical stimulation for each session

  • Electrical stimulation parameters:

    • Continuous 50 Hz current
    • Charge-balanced, biphasic (each phase is 200 microsec), rectangular waveform
    • Intensity to subject's tolerance for ten minutes then increased to a mildly uncomfortable level
Other Names:
  • PNT
  • Vertis
Sham Comparator: TENS
Device: Transcutaneous Electrical Nerve Stimulation (TENS)
  • Ten TENS sessions in eleven weeks
  • On average, one TENS session per week
  • Four 2-inch (5.1 centimeters) diameter pads applied per TENS lumbar montage
  • Forty-five minutes of electrical stimulation for each session

  • Electrical stimulation parameters:

    • Current at 2 Hz-low frequency
    • Pulse trains delivered as asymmetric, biphasic, square waveform current, with pulse width lasting 20 microsec
    • Intensity titrated according to subject's sensory threshold
    • To maintain blinding, the treating physician or clinician will check on the subject after 10 minutes and dial the channels down just prior to the point of turning off the device.
Other Names:
  • Transcutaneous electrical nerve stimulation
  • TENS
  • surface stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Time-averaged Pain Intensity Visual Analog Scale (VAS) Score
Time Frame: Time-averaged from the first available observation to the last available observation (12 months for completed subjects)
Visual analog scale (VAS) for pain (100mm line with "0/No pain" on the left and "100/Worst pain imaginable" on the right). Subjects drew vertical line to indicate pain. Time-averaged method accounts for time between visits by dividing area beneath the score curve by time between first and last available visits.
Time-averaged from the first available observation to the last available observation (12 months for completed subjects)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Expenditure Per Day on All Lower Back Pain Related Interventions
Time Frame: Baseline, Month 01, Month 02, Month 04, Month 06, Month 08, Month 10, Month 12
Expenditures were assessed by patient report at each visit. Interventions were coded to Current Procedural Terminology (CPT) 2008; costs were derived from Medicare, Managed Care, and Workers' Comp fees. Costs for providers assume 30 minutes at returning patient rate. Drug costs were coded to a dictionary extrapolated from 2008 market prices.
Baseline, Month 01, Month 02, Month 04, Month 06, Month 08, Month 10, Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RS Medical

Investigators

  • Study Director: William Carroll, RS Medical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

February 8, 2006

First Submitted That Met QC Criteria

February 8, 2006

First Posted (Estimate)

February 10, 2006

Study Record Updates

Last Update Posted (Estimate)

June 1, 2009

Last Update Submitted That Met QC Criteria

May 8, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSMED-K011702-PNT02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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