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Slow recruitment and high dropout rates
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PNT | Experimental |
| |
| TENS | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vertis Percutaneous Neuromodulation Therapy (PNT) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Time-averaged Pain Intensity Visual Analog Scale (VAS) Score | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Total Expenditure Per Day on All Lower Back Pain Related Interventions | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Carroll | RS Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Pain Research Center | La Jolla | California | 92037 | United States | ||
| Center for Prospective Outcome Studies |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11159255 | Background | White PF, Ghoname EA, Ahmed HE, Hamza MA, Craig WF, Vakharia AS. The effect of montage on the analgesic response to percutaneous neuromodulation therapy. Anesth Analg. 2001 Feb;92(2):483-7. doi: 10.1097/00000539-200102000-00038. | |
| 10195535 | Background | Ghoname ES, Craig WF, White PF, Ahmed HE, Hamza MA, Gajraj NM, Vakharia AS, Noe CE. The effect of stimulus frequency on the analgesic response to percutaneous electrical nerve stimulation in patients with chronic low back pain. Anesth Analg. 1999 Apr;88(4):841-6. doi: 10.1097/00000539-199904000-00030. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Percutaneous Neuromodulation Therapy (PNT) | Active/test group receiving 10 Percutaneous Neuromodulation Therapy (PNT) sessions of 45 minutes each over 11 weeks. PNT delivers 50 Hz current in a charge-balanced, biphasic, rectangular waveform. |
| FG001 | Transcutaneous Electrical Nerve Stimulation (TENS) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Transcutaneous Electrical Nerve Stimulation (TENS) | Device |
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| Baseline, Month 01, Month 02, Month 04, Month 06, Month 08, Month 10, Month 12 |
| Atlanta |
| Georgia |
| 03027 |
| United States |
| Mossberg Research Group | Eugene | Oregon | 97401 | United States |
| Pain Specialists of Southern Oregon | Medford | Oregon | 97504 | United States |
| Neuropsychiatric Pain Medicine Association of Tennessee | Knoxville | Tennessee | 37922 | United States |
| Physical Medicine & Rehabilitation Center | Seymour | Tennessee | 37865 | United States |
| Texas Back Institute - Denton | Denton | Texas | 76208 | United States |
| Texas Back Institute CRO | Plano | Texas | 75093 | United States |
| 11004055 | Background | White PF, Craig WF, Vakharia AS, Ghoname E, Ahmed HE, Hamza MA. Percutaneous neuromodulation therapy: does the location of electrical stimulation effect the acute analgesic response? Anesth Analg. 2000 Oct;91(4):949-54. doi: 10.1097/00000539-200010000-00034. |
| 17163911 | Background | Borg-Stein J, Seroussi RE, Gomba L, Meleger A, Schmitt S, Leep E, Glassman JH, Revord J, Condon J, Bensen E, Fitzthum JE, Fowler BC, Gliner BE, Firlik AD. Safety and efficacy of percutaneous neuromodulation therapy in the management of subacute radiating low back pain. Pain Pract. 2003 Jun;3(2):125-34. doi: 10.1046/j.1533-2500.2003.03019.x. |
Sham comparator group receiving 10 TENS sessions of 45 minutes each over 11 weeks. Delivered 2 Hz pulse trains as asymmetric, biphasic, square waves with pulse width of 20 microseconds. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Percutaneous Neuromodulation Therapy (PNT) | Active/test group receiving 10 Percutaneous Neuromodulation Therapy (PNT) sessions of 45 minutes each over 11 weeks. PNT delivers 50 Hz current in a charge-balanced, biphasic, rectangular waveform. |
| BG001 | Transcutaneous Electrical Nerve Stimulation (TENS) | Sham comparator group receiving 10 TENS sessions of 45 minutes each over 11 weeks. Delivered 2 Hz pulse trains as asymmetric, biphasic, square waves with pulse width of 20 microseconds. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Categorical | One subject had an invalid birth date and was excluded from the Age Categorical counts. | Number | participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Time-averaged Pain Intensity Visual Analog Scale (VAS) Score | 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. | Analysis population was intention to treat (ITT), excluding subjects who had no follow-up (after the initial 10-week treatment phase) data available. | Posted | Least Squares Mean | Standard Error | mm | Time-averaged from the first available observation to the last available observation (12 months for completed subjects) |
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| Secondary | Total Expenditure Per Day on All Lower Back Pain Related Interventions | 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. | Analysis population was intention to treat (ITT). | Posted | Median | Full Range | Dollars | Baseline, Month 01, Month 02, Month 04, Month 06, Month 08, Month 10, Month 12 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Percutaneous Neuromodulation Therapy (PNT) | Active/test group receiving 10 Percutaneous Neuromodulation Therapy (PNT) sessions of 45 minutes each over 11 weeks. PNT delivers 50 Hz current in a charge-balanced, biphasic, rectangular waveform. | 3 | 29 | ||||
| EG001 | Transcutaneous Electrical Nerve Stimulation (TENS) | Sham comparator group receiving 10 TENS sessions of 45 minutes each over 11 weeks. Delivered 2 Hz pulse trains as asymmetric, biphasic, square waves with pulse width of 20 microseconds. | 3 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bruise/abrasion/fracture/other injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Surgery | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Myocardial infarction | Cardiac disorders | Non-systematic Assessment |
| ||
| Low back pain (serious events) | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Low back pain (non-serious events) | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Leg/buttock/hip or radiating pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Arm/shoulder pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Bruise/abrasion/fracture/other injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Headache | General disorders | Non-systematic Assessment |
| ||
| Drug reaction | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Virus | Infections and infestations | Non-systematic Assessment |
| ||
| Urinary/bladder infection | Infections and infestations | Non-systematic Assessment |
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If the PI expects to participate in the publication or presentation of data generated in the performance of the study, any reports, abstracts, manuscripts, or other presentation materials shall be submitted to the sponsor for review prior to submission for publication or presentation. The sponsor shall have 30 calendar days to respond with any requested revisions in order to protect the sponsor's confidential information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Manager | RS Medical | 360-891-7299 |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
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| Title | Measurements |
|---|---|
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| >=65 years |
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| Male |
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