Percutaneous Neuromodulation Therapy (PNT) With Chronic Low Back Pain Patients
TerminatedPhase 4NCT00290238
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- Percutaneous Neuromodulation Therapy With Chronic Low Back Pain Patients With or Without Lower Extremity Pain - A Randomized, Controlled, Parallel Groups Study
- Conditions
- Interventions
- Device: Vertis Percutaneous Neuromodulation Therapy (PNT)
- Device: Transcutaneous Electrical Nerve Stimulation (TENS)
- Sponsor
- RS Medical
- Start date
- 2005-12
- Primary completion
- 2007-11
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 8
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00290238