Trial record 1 of 1 for:    NCT00290238
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Percutaneous Neuromodulation Therapy (PNT) With Chronic Low Back Pain Patients

This study has been terminated.
(Slow recruitment and high dropout rates)
Sponsor:
Information provided by:
RS Medical
ClinicalTrials.gov Identifier:
NCT00290238
First received: February 8, 2006
Last updated: May 8, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Low Back Pain
Device: Vertis Percutaneous Neuromodulation Therapy (PNT)
Device: Transcutaneous Electrical Nerve Stimulation (TENS)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Percutaneous Neuromodulation Therapy With Chronic Low Back Pain Patients With or Without Lower Extremity Pain - A Randomized, Controlled, Parallel Groups Study

Resource links provided by NLM:


Further study details as provided by RS Medical:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 122
Study Start Date: December 2005
Study Completion Date: September 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • TENS
  • Transcutaneous electrical nerve stimulation
  • surface stimulation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290238

Locations
United States, California
UCSD Pain Research Center
La Jolla, California, United States, 92037
United States, Georgia
Center for Prospective Outcome Studies
Atlanta, Georgia, United States, 03027
United States, Oregon
Mossberg Research Group
Eugene, Oregon, United States, 97401
Pain Specialists of Southern Oregon
Medford, Oregon, United States, 97504
United States, Tennessee
Neuropsychiatric Pain Medicine Association of Tennessee
Knoxville, Tennessee, United States, 37922
Physical Medicine & Rehabilitation Center
Seymour, Tennessee, United States, 37865
United States, Texas
Texas Back Institute - Denton
Denton, Texas, United States, 76208
Texas Back Institute CRO
Plano, Texas, United States, 75093
Sponsors and Collaborators
RS Medical
Investigators
Study Director: William Carroll RS Medical
  More Information

Publications:
Responsible Party: Vice President of Research and Development, RS Medical
ClinicalTrials.gov Identifier: NCT00290238     History of Changes
Other Study ID Numbers: RSMED-K011702-PNT02
Study First Received: February 8, 2006
Results First Received: November 25, 2008
Last Updated: May 8, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by RS Medical:
Chronic Low Back Pain
Lower Extremity Pain
Central Sensitization
Percutaneous Neuromodulation Therapy

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 29, 2014