Low Back PainPhase 4NCT00290238
Percutaneous Neuromodulation Therapy (PNT) With Chronic Low Back Pain Patients
A Phase 4 study testing Vertis Percutaneous Neuromodulation Therapy (PNT) and Transcutaneous Electrical Nerve Stimulation (TENS) in people with Low Back Pain, run by RS Medical at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Vertis Percutaneous Neuromodulation Therapy (PNT) and Transcutaneous Electrical Nerve Stimulation (TENS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 8 sitesUnited States
- Study dates
- Dec 2005to Sep 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Center for Prospective Outcome Studies
Atlanta, Georgia, 03027
Texas Back Institute - Denton
Denton, Texas, 76208
Mossberg Research Group
Eugene, Oregon, 97401
Neuropsychiatric Pain Medicine Association of Tennessee
Knoxville, Tennessee, 37922
UCSD Pain Research Center
La Jolla, California, 92037
Pain Specialists of Southern Oregon
Medford, Oregon, 97504
Texas Back Institute CRO
Plano, Texas, 75093
Physical Medicine & Rehabilitation Center
Seymour, Tennessee, 37865
About this study
Official title: Percutaneous Neuromodulation Therapy With Chronic Low Back Pain Patients With or Without Lower Extremity Pain - A Randomized, Controlled, Parallel Groups Study
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.
- Conditions
- Low Back Pain
- Being tested
- Vertis Percutaneous Neuromodulation Therapy (PNT), Transcutaneous Electrical Nerve Stimulation (TENS)
- Keywords
- Chronic Low Back Pain, Lower Extremity Pain, Central Sensitization, Percutaneous Neuromodulation Therapy
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vertis Percutaneous Neuromodulation Therapy (PNT)Device
Also called PNT, Vertis
- 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
Transcutaneous Electrical Nerve Stimulation (TENS)Device
Also called TENS, Transcutaneous electrical nerve stimulation, surface stimulation
- 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.
| Study group | Role | What they receive |
|---|---|---|
| PNT | Experimental | Not described Receives: Device: Vertis Percutaneous Neuromodulation Therapy (PNT) |
| TENS | Sham comparator | Not described Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time-averaged from the first available observation to the last available observation (12 months for completed subjects)
Secondary outcomes (1)
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.
Measured: Baseline, Month 01, Month 02, Month 04, Month 06, Month 08, Month 10, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2006 (estimated)
- Study startDec 2005
- Primary completionNov 2007
- Study completionSep 2008
Why it stopped: Slow recruitment and high dropout rates
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- RS Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- William Carroll, Study director, RS Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00290238
- Sponsor's protocol ID
- RSMED-K011702-PNT02
- Status last verified
- May 2009
- First submitted
- 8 Feb 2006
- Last updated
- 1 Jun 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 11159255Ghoname 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.
PubMed 10195535White 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.
PubMed 11004055Borg-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.
PubMed 17163911
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Neuromodulation Therapy With Chronic Low Back Pain Patients With or Without Lower Extremity Pain - A Randomized, Controlled, Parallel Groups Study
- ClinicalTrials.gov ID
- NCT00290238
- Acronym / sponsor ID
- RSMED-K011702-PNT02
- Conditions
- Low Back Pain
- Keywords
- Chronic Low Back Pain, Lower Extremity Pain, Central Sensitization, Percutaneous Neuromodulation Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment and high dropout rates
- Enrolment
- 122 participants (actual)
- Lead sponsor
- RS MedicalIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Nov 2007 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 10 Feb 2006 (estimated)
- Results
- Posted 9 Mar 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PNT | Experimental | Device: Vertis Percutaneous Neuromodulation Therapy (PNT) |
| TENS | Sham comparator | Device: Transcutaneous Electrical Nerve Stimulation (TENS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vertis Percutaneous Neuromodulation Therapy (PNT)Also: PNT, Vertis* 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 | Device | PNT |
| Transcutaneous Electrical Nerve Stimulation (TENS)Also: TENS, Transcutaneous electrical nerve stimulation, surface stimulation* 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. | Device | TENS |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11159255White 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.
- Background: PubMed 10195535Ghoname 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.
- Background: PubMed 11004055White 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.
- Background: PubMed 17163911Borg-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.
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Carroll study director
RS Medical
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vertis Percutaneous Neuromodulation Therapy (PNT) and Transcutaneous Electrical Nerve Stimulation (TENS) in people with Low Back Pain, run by RS Medical at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00290238, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2009.