Status:
TERMINATED
Percutaneous Neuromodulation Therapy (PNT) With Chronic Low Back Pain Patients
Lead Sponsor:
RS Medical
Conditions:
Low Back Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 interve...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT00290238
Start Date
December 1 2005
End Date
September 1 2008
Last Update
June 1 2009
Active Locations (8)
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1
UCSD Pain Research Center
La Jolla, California, United States, 92037
2
Center for Prospective Outcome Studies
Atlanta, Georgia, United States, 03027
3
Mossberg Research Group
Eugene, Oregon, United States, 97401
4
Pain Specialists of Southern Oregon
Medford, Oregon, United States, 97504