Chronic PainACCELERATENCT02093793

Safety and Effectiveness Study of the Precision SCS Systems Adapted for High-Rate Spinal Cord Stimulation

A study testing PRECISION SCS Adapted for High-Rate SCS in people with Chronic Pain and Back Pain, run by Boston Scientific Corporation at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the safety and effectiveness of the Precision Spinal Cord Stimulator Systems Adapted for High-Rate Spinal Cord Stimulation as an aid in the management of chronic intractable pain Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Chronic Pain, Back Pain
What is being tested?: PRECISION SCS Adapted for High-Rate SCS
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 383 participants
Where: 20 sitesUnited States
Study dates: 27 Mar 2014to 29 Aug 2019
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 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have been diagnosed with chronic, intractable pain of the trunk (NRS ≥ 5) which has been refractory to conservative therapy for a minimum of 90 days.
Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
Be 22 years of age or older at the time of enrollment
Be willing and capable of giving informed consent
Be willing and able to comply with study-related requirements, procedures, and visits

Who cannot join

Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome, as determined by a psychologist
Have previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
Have a current systemic infection, or local infection in close proximity to anticipated surgical field
Pregnant or plan to get pregnant during the course of the study or not using adequate contraception.
Be participating in another clinical study that may influence the data collected for the study

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

Coastal Pain & Spinal Diagnostics
Carlsbad, California, 92009
Rush University Medical Center
Chicago, Illinois, 60612
University Hospitals of Cleveland
Cleveland, Ohio, 44106
MAPS Applied Research Center
Edina, Minnesota, 55433
Pacific Sports and Spine, LLC
Eugene, Oregon, 97401
Pain Consultants of Oregon
Eugene, Oregon, 97401
UCSD Medical Center - Jacobs Medical Center
La Jolla, California, 92037
Hope Research Institute
Las Vegas, Nevada, 89128
Compass Research, LLC
Orlando, Florida, 32806
Hope Research Institute
Phoenix, Arizona, 85018
Oregon Health Sciences University
Portland, Oregon, 97239
Mayo Clinic Foundation
Rochester, Minnesota, 55905
San Diego Pain Institute
San Diego, California, 92111
Pacific Medical Center
Seattle, Washington, 98104
Willis-Knighton River Cities Clinical Research Center
Shreveport, Louisiana, 71105
Premier Pain Centers, LLC
Shrewsbury, New Jersey, 07702
Mercy Medical Research Institute
Springfield, Missouri, 65804
Oregon Neurosurgery
Springfield, Oregon, 97477
Precision Spine Care
Tyler, Texas, 75701
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Randomized Controlled Study to Evaluate the Safety and Effectiveness of the Precision Spinal Cord Stimulator Systems Adapted for High-Rate Spinal Cord Stimulation

To evaluate the safety and effectiveness of the Precision Spinal Cord Stimulator Systems Adapted for High-Rate Spinal Cord Stimulation as an aid in the management of chronic intractable pain

Read the detailed description

To evaluate the safety and effectiveness of high rate spinal cord stimulation (HR-SCS) therapy as an aid in the management of chronic intractable pain of the trunk using the Boston Scientific (BSC) PRECISION Spinal Cord Stimulator Systems Adapted for High-Rate Spinal Cord Stimulation

Conditions: Chronic Pain, Back Pain
Being tested: PRECISION SCS Adapted for High-Rate SCS
Medical subject headings: Chronic Pain, Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PRECISION SCS Adapted for High-Rate SCSDevice
Also called Boston Scientific PRECISION Spinal Cord Stimulator System
Comparison of spinal cord stimulation parameters

Study groups in NCT02093793
Study group	Role	What they receive
High Rate Spinal Cord Stimulation	Experimental	PRECISION SCS Adapted for High-Rate SCS Receives: Device: PRECISION SCS Adapted for High-Rate SCS
Commercial Rate Spinal Cord Stimulation	Active comparator	PRECISION SCS Adapted for High-Rate SCS Receives: Device: PRECISION SCS Adapted for High-Rate SCS

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Responders as Determined by the Cumulative Distribution Function (CDF) of Response Rates
Cummulative distribution function (CDF) of response rates from 0% - 100% numerical rating score (NRS) to derive the entire range of possible responder definitions. This allows us to determine the range of success for all responder rates without the need to identify a certain cutoff (for example, use a 50% responder rate).
A comparison between the two CDF's was performed by comparing the area under the curves since area between CDFs is equal to the mean difference in low back pain reduction for CR-SCS and HR-SCS. Hence, it can be used to estimate the true underlying difference in responder rates between CR-SCS and HR-SCS
Measured: 3 months post-activation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Mar 201429 Aug 2019

First posted21 Mar 2014 (estimated)
Study start27 Mar 2014
Primary completionDec 2018
Study completion29 Aug 2019

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: None (open label)
Enrolment: 383 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02093793
Sponsor's protocol ID: A4007
Acronym: ACCELERATE
Status last verified: Nov 2020
First submitted: 19 Mar 2014
Last updated: 13 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Study to Evaluate the Safety and Effectiveness of the Precision Spinal Cord Stimulator Systems Adapted for High-Rate Spinal Cord Stimulation
ClinicalTrials.gov ID: NCT02093793
Acronym / sponsor ID: ACCELERATE / A4007
Conditions: Chronic Pain, Back Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 383 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: 27 Mar 2014 (actual)
Primary completion: Dec 2018 (actual)
Study completion: 29 Aug 2019 (actual)
First posted: 21 Mar 2014 (estimated)
Results: Posted 8 Jul 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To evaluate the safety and effectiveness of the Precision Spinal Cord Stimulator Systems Adapted for High-Rate Spinal Cord Stimulation as an aid in the management of chronic intractable pain

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
High Rate Spinal Cord Stimulation	Experimental	Device: PRECISION SCS Adapted for High-Rate SCSPRECISION SCS Adapted for High-Rate SCS
Commercial Rate Spinal Cord Stimulation	Active comparator	Device: PRECISION SCS Adapted for High-Rate SCSPRECISION SCS Adapted for High-Rate SCS

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Have been diagnosed with chronic, intractable pain of the trunk (NRS ≥ 5) which has been refractory to conservative therapy for a minimum of 90 days.
Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
Be 22 years of age or older at the time of enrollment
Be willing and capable of giving informed consent
Be willing and able to comply with study-related requirements, procedures, and visits

Key exclusion criteria (6 listed)

Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome, as determined by a psychologist
Have previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
Have a current systemic infection, or local infection in close proximity to anticipated surgical field
Pregnant or plan to get pregnant during the course of the study or not using adequate contraception.

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
PRECISION SCS Adapted for High-Rate SCSAlso: Boston Scientific PRECISION Spinal Cord Stimulator SystemComparison of spinal cord stimulation parameters	Device	Commercial Rate Spinal Cord Stimulation, High Rate Spinal Cord Stimulation

Primary outcome

Proportion of Responders as Determined by the Cumulative Distribution Function (CDF) of Response Rates
Time frame: 3 months post-activation
Cummulative distribution function (CDF) of response rates from 0% - 100% numerical rating score (NRS) to derive the entire range of possible responder definitions. This allows us to determine the range of success for all responder rates without the need to identify a certain cutoff (for example, use a 50% responder rate). A comparison between the two CDF's was performed by comparing the area under the curves since area between CDFs is equal to the mean difference in low back pain reduction for CR-SCS and HR-SCS. Hence, it can be used to estimate the true underlying difference in responder rates between CR-SCS and HR-SCS

Results and safety

Results posted to the registry on 8 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High Rate SCS Followed by Commercial SCS	98	91
Commercial SCS Settings Followed by High Rate SCS	90	80
High Rate Settings Only	68	65

Primary outcome: Proportion of Responders as Determined by the Cumulative Distribution Function (CDF) of Response Rates

Time frame: 3 months post-activation. Number. Unit: probability

Measure	Commercial SCS n = 30	High Rate SCS n = 38	High Rate Settings Only n = 65
Value	0.47	0.53	0.4

Population analysed: Subjects with a successful trial (High rate settings only) or simulated trial responders (High rate SCS followed by Commercial SCS or vice versa)

Adverse events

Time frame: All adverse events were collected through end of crossover phase (High Rate SCS followed by Commercial SCS or vice versa group) or up to 3 months post activation (HR settings only group) for subjects who started the study (n = 256). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High Rate SCS	8 of 188 (4.3%)	11 of 188 (5.9%)	1 of 188
Commercial SCS	3 of 188 (1.6%)	13 of 188 (6.9%)	0 of 188
High Rate Settings Only	2 of 68 (2.9%)	4 of 68 (5.9%)	0 of 68

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Marine Lipids Ease Painful TMD
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RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
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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.

Mark Wallace, M.D. principal investigator

University of California, San Diego

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PRECISION SCS Adapted for High-Rate SCS in people with Chronic Pain and Back Pain, run by Boston Scientific Corporation at 20 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 5 inclusion and 6 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 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 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. 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 8 Jul 2020). 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?

Proportion of Responders as Determined by the Cumulative Distribution Function (CDF) of Response Rates (time frame: 3 months post-activation). 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 NCT02093793.

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 13 Nov 2020.