Chronic PainNCT01624740
High Rate Spinal Cord Stimulation (SCS) for Chronic Pain
A study testing Low Rate Stimulation and High Rate Stimulation in people with Chronic Pain, run by Boston Scientific Corporation at 1 site in United States.
Trial summary
To determine the effects of varying spinal cord stimulation programming parameters, including stimulation rate, on pain intensity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Low Rate Stimulation and High Rate Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Dec 2013
- Phase
- Interventional
- 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
- Chronic intractable pain of the trunk and/or limbs
- Documented history of trunk and/or limb pain of at least 180 days
- Average back pain intensity of 5 or greater on a 0-10 numerical rating scale during the 7-day period prior to the Screening Visit
- Pass study site's routine psychological/psychiatric evaluation within 180 days of the Trial Lead Insertion Visit
- If taking any medications for chronic pain, must be on a stable prescription during the 14-day period prior to the Trial Lead Insertion Visit and agree to continue on the same prescription throughout study participation
- Subject is willing and able to comply with all protocol-required procedures and assessments/evaluations
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- Subject is able to independently read and complete all questionnaires and/or assessments provided in English
- 18 years of age or older when written informed consent is obtained
- Subject signs a valid, Institutional Review Board (IRB)-approved informed consent form (ICF) provided in English
Who cannot join
- Unable to operate the Precision Plus system
- Primary source of pain is cancer-related, pelvic, visceral, angina, or migraine
- Is a high surgical risk
- Is diabetic
- Is immunocompromised
- Currently on any anticoagulant medications that cannot be discontinued during perioperative period
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- Untreated major depression or untreated generalized anxiety disorder
- Diagnosed with somatoform disorder, severe personality disorder, borderline personality disorder
- Diagnosed with any major psychiatric disorder not specifically listed in CE7 or CE8
- Currently diagnosed with cognitive impairment that would limit subject's ability to discern differences in pain severity, complete a pain diary, perform wound care
- Current abuse of alcohol or illicit drugs
- Subject requires Magnetic Resonance Imaging (MRI) while implanted with lead(s).
- Subject is participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study
- Subject has previously undergone a spinal cord stimulation trial or is already implanted with an active implantable device(s) to treat their pain (Implantable Pulse Generators (IPGs), implantable drug pump, etc.) or pacemaker or implantable cardiac defibrillator
- Patient is a woman who is not using adequate contraception, is pregnant or breastfeeding or intends to become pregnant during the course of the study (a urine pregnancy test must be performed within 28 days prior to the Trial Lead Insertion Visit in women of child-bearing potential and the test result documented)
Trial locations and contacts
1 site in 1 country.
United States1 site
Coastal Pain Spinal Diagnostic
Carlsbad, California, 92009
About this study
Official title: Precision Plus™ High-Rate Subperception SCS for the Treatment of Chronic Intractable Pain
To determine the effects of varying spinal cord stimulation programming parameters, including stimulation rate, on pain intensity.
Read the detailed description
This study compared the effects of high-rate subperception stimulation with the effects of low-rate subperception stimulation on pain intensity.
- Conditions
- Chronic Pain
- Being tested
- Low Rate Stimulation, High Rate Stimulation
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Rate StimulationDevice
Stimulation was given at a rate of 2 Hz.
High Rate StimulationDevice
Stimulation was given at a rate of 1200 Hz.
| Study group | Role | What they receive |
|---|---|---|
| Low Rate Followed By High Rate | Experimental | The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects received low rate stimulation (2 Hz) for 3-4 days, followed by high rate stimulation (1200 Hz) for 3-4 days. Receives: Device: Low Rate Stimulation; Device: High Rate Stimulation |
| High Rate Followed By Low Rate | Experimental | The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects received high rate stimulation (1200 Hz) for 3-4 days, followed by low rate stimulation (2 Hz) for 3-4 days. Receives: Device: Low Rate Stimulation; Device: High Rate Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Back Pain Intensity
Back pain intensity was measured on a 0-10 numerical rating scale (0="no pain", 10="worst pain imaginable") at baseline and following low rate and high rate stimulation. This outcome measure compared the change in intensity from baseline between low rate and high rate stimulation.
Measured: For this measure, outcome was assessed at baseline, the end of the first intervention (3 or 4 days post-implantation, depending on the subject), and the end of the second intervention (6 or 8 days post-implantation, depending on the subject).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionSep 2013
- Study completionDec 2013
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.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Omid Khodai, OD, Study director, Boston Scientific Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01624740
- Sponsor's protocol ID
- A7001
- Status last verified
- Dec 2014
- First submitted
- 15 Jun 2012
- Last updated
- 20 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Plus™ High-Rate Subperception SCS for the Treatment of Chronic Intractable Pain
- ClinicalTrials.gov ID
- NCT01624740
- Acronym / sponsor ID
- A7001
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 21 Jun 2012 (estimated)
- Results
- Posted 20 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the effects of varying spinal cord stimulation programming parameters, including stimulation rate, on pain intensity.
Detailed description
This study compared the effects of high-rate subperception stimulation with the effects of low-rate subperception stimulation on pain intensity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Rate Followed By High Rate | Experimental | Device: Low Rate Stimulation, Device: High Rate StimulationThe Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects received low rate stimulation (2 Hz) for 3-4 days, followed by high rate stimulation (1200 Hz) for 3-4 days. |
| High Rate Followed By Low Rate | Experimental | Device: Low Rate Stimulation, Device: High Rate StimulationThe Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects received high rate stimulation (1200 Hz) for 3-4 days, followed by low rate stimulation (2 Hz) for 3-4 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Chronic intractable pain of the trunk and/or limbs
- Documented history of trunk and/or limb pain of at least 180 days
- Average back pain intensity of 5 or greater on a 0-10 numerical rating scale during the 7-day period prior to the Screening Visit
- Pass study site's routine psychological/psychiatric evaluation within 180 days of the Trial Lead Insertion Visit
- If taking any medications for chronic pain, must be on a stable prescription during the 14-day period prior to the Trial Lead Insertion Visit and agree to continue on the same prescription throughout study participation
Key exclusion criteria (15 listed)
- Unable to operate the Precision Plus system
- Primary source of pain is cancer-related, pelvic, visceral, angina, or migraine
- Is a high surgical risk
- Is diabetic
- Is immunocompromised
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 |
|---|---|---|
| Low Rate StimulationStimulation was given at a rate of 2 Hz. | Device | High Rate Followed By Low Rate, Low Rate Followed By High Rate |
| High Rate StimulationStimulation was given at a rate of 1200 Hz. | Device | High Rate Followed By Low Rate, Low Rate Followed By High Rate |
Primary outcome
Change in Back Pain Intensity
Time frame: For this measure, outcome was assessed at baseline, the end of the first intervention (3 or 4 days post-implantation, depending on the subject), and the end of the second intervention (6 or 8 days post-implantation, depending on the subject).
Back pain intensity was measured on a 0-10 numerical rating scale (0="no pain", 10="worst pain imaginable") at baseline and following low rate and high rate stimulation. This outcome measure compared the change in intensity from baseline between low rate and high rate stimulation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Omid Khodai, OD study director
Boston Scientific Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Rate Stimulation and High Rate Stimulation in people with Chronic Pain, run by Boston Scientific Corporation at 1 site 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 9 inclusion and 15 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: finished, as of the sponsor's last update on 20 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2015). 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 in Back Pain Intensity (time frame: For this measure, outcome was assessed at baseline, the end of the first intervention (3 or 4 days post-implantation, depending on the subject), and the end of the second intervention (6 or 8 days post-implantation, depending on the subject).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2015.