Percutaneous Neuromodulation Therapy With Chronic Low Back Pain Patients With or Without Lower Extremity Pain - A Randomized, Controlled, Parallel Groups Study
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Low Back Pain
- Sponsor
- RS Medical
- Enrollment
- 122
- Locations
- 8
- Primary Endpoint
- Change From Baseline in Time-averaged Pain Intensity Visual Analog Scale (VAS) Score
- Status
- Terminated
- Last Updated
- 16 years ago
Overview
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 intervention for chronic low back pain with or without a radiating lower extremity pain component.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Total Expenditure Per Day on All Lower Back Pain Related Interventions(Baseline, Month 01, Month 02, Month 04, Month 06, Month 08, Month 10, Month 12)