Chronic PainCOVERAGENCT02384096

A Study to Evaluate the Effect of Precision Spectra™ Programming Features and Lead Options on Patient Outcomes

A study testing Conventional single source programming and Precision Spectra SCS System advanced programming in people with Chronic Pain, run by Boston Scientific Corporation at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

The study is a prospective, on-label, multi-center, blinded, randomized controlled trial with a cross-over design to evaluate the effect of Precision Spectra™ SCS System's programming features and lead options. 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?: Conventional single source programming and Precision Spectra SCS System advanced programming
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 4 sitesUnited States
Study dates: Feb 2015to Oct 2016
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

Meets RELIEF Registry criteria for inclusion
Primary complaint of persistent or recurrent low back pain, with or without leg pain
Signed a valid, IRB/EC-approved informed consent form

Who cannot join

Meets any RELIEF Registry criteria for exclusion

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Albany Medical Center
Albany, New York, 12208
PCPMG Clinical Research Unit, LLC
Greenville, South Carolina, 29601
Physicians Research Group, LLC
Phoenix, Arizona, 85016
Spine Team Texas
Rockwall, Texas, 75032

Other trials in United States

About this study

Official title: COVERAGE - A Study to Evaluate the Effect of Precision Spectra™ SCS System's Programming Features and Lead Options on Patient Outcomes

Read the detailed description

The study is a sub-study of RELIEF - A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain (NCT01719055). The treatment will consist of permanent implant of a Precision Spectra™ SCS IPG with either a 32 contact CoverEdge™ Surgical Lead or with more than 2 percutaneous leads after a successful trial. Programming features and lead options of the Precision Spectra™ SCS System will be evaluated up to 3 months post-IPG activation. Following completion of the 3 month visit, subjects will continue to be followed for up to 36 months per the study requirements of the RELIEF Registry.

Conditions: Chronic Pain
Being tested: Conventional single source programming, Precision Spectra SCS System advanced programming
Keywords: stimulation, implantable, pulse generator, back pain, chronic pain, leg pain
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.

Conventional single source programmingDevice
Precision Spectra SCS System using conventional single source programming.
Precision Spectra SCS System advanced programmingDevice
Precision Spectra SCS System using advanced programming

Study groups in NCT02384096
Study group	Role	What they receive
Conventional Programming, then Advanced Programming	Active comparator	Precision Spectra SCS System with CoverEdge Surgical Lead or more than 2 percutaneous leads. Subjects first received conventional single source programming followed by Precision Spectra SCS System advanced programming. Receives: Device: Conventional single source programming; Device: Precision Spectra SCS System advanced programming
Advanced Programming, then Conventional Programming	Active comparator	Precision Spectra SCS System with CoverEdge Surgical Lead or more than 2 percutaneous leads. Subjects first received Precision Spectra SCS System advanced programming followed by conventional single source programming. Receives: Device: Conventional single source programming; Device: Precision Spectra SCS System advanced programming

What is being measured

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

Number of Participants With Paresthesia Coverage ≥50%
Paresthesia Coverage assesses how much of the subject's painful areas are covered by SCS-induced paresthesia. The number of subjects reporting paresthesia coverage ≥50% is reported.
Measured: 7, 14 days post activation

Timeline

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

Feb 2015Oct 2016

First posted10 Mar 2015 (estimated)
Study startFeb 2015
Primary completionOct 2016
Study completionOct 2016

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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02384096
Sponsor's protocol ID: 90968587
Acronym: COVERAGE
Status last verified: Nov 2020
First submitted: 28 Jan 2015
Last updated: 20 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

Enrolling by invitation
Efficacy of a Chronic Pain Treatment Prior to Gender-affirming Surgery
Pain Catastrophizing, Pain, Chronic
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
Recruiting
Uncovering the Mechanism of Pain Relief by Peripheral Transcutaneous Magnetic Stimulation
Post-Surgical Pain, Chronic, Post-traumatic Pain, Chronic
Recruiting
Daily Knee Sleeve Use Versus No Use in Older Adults With Chronic Knee Pain
Knee Arthritis, Osteoarthritis

All Chronic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: COVERAGE - A Study to Evaluate the Effect of Precision Spectra™ SCS System's Programming Features and Lead Options on Patient Outcomes
ClinicalTrials.gov ID: NCT02384096
Acronym / sponsor ID: COVERAGE / 90968587
Conditions: Chronic Pain
Keywords: stimulation, implantable, pulse generator, back pain, chronic pain, leg pain
Study type: Interventional
Recruitment status: Terminated
Enrolment: 17 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: Feb 2015
Primary completion: Oct 2016 (actual)
Study completion: Oct 2016 (actual)
First posted: 10 Mar 2015 (estimated)
Results: Posted 19 Jul 2018

Clinical summary

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

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Conventional Programming, then Advanced Programming	Active comparator	Device: Conventional single source programming, Device: Precision Spectra SCS System advanced programmingPrecision Spectra SCS System with CoverEdge Surgical Lead or more than 2 percutaneous leads. Subjects first received conventional single source programming followed by Precision Spectra SCS System advanced programming.
Advanced Programming, then Conventional Programming	Active comparator	Device: Conventional single source programming, Device: Precision Spectra SCS System advanced programmingPrecision Spectra SCS System with CoverEdge Surgical Lead or more than 2 percutaneous leads. Subjects first received Precision Spectra SCS System advanced programming followed by conventional single source programming.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Meets RELIEF Registry criteria for inclusion
Primary complaint of persistent or recurrent low back pain, with or without leg pain
Signed a valid, IRB/EC-approved informed consent form

Key exclusion criteria (1 listed)

Meets any RELIEF Registry criteria for exclusion

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
Conventional single source programmingPrecision Spectra SCS System using conventional single source programming.	Device	Advanced Programming, then Conventional Programming, Conventional Programming, then Advanced Programming
Precision Spectra SCS System advanced programmingPrecision Spectra SCS System using advanced programming	Device	Advanced Programming, then Conventional Programming, Conventional Programming, then Advanced Programming

Primary outcome

Number of Participants With Paresthesia Coverage ≥50%
Time frame: 7, 14 days post activation
Paresthesia Coverage assesses how much of the subject's painful areas are covered by SCS-induced paresthesia. The number of subjects reporting paresthesia coverage ≥50% is reported.

Results and safety

Results posted to the registry on 19 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Conventional Programming, Then Advanced Programming	5	4
Advanced Programming, Then Conventional Programming	7	7

Primary outcome: Number of Participants With Paresthesia Coverage ≥50%

Time frame: 7, 14 days post activation. Number. Unit: Participants

Measure	Conventional Programming, Then Advanced Programming n = 4	Advanced Programming, Then Conventional Programming n = 7
Advanced Programming	3	5
Conventional Programming	3	5

Population analysed: All subjects who completed the day 7 and day 14 post-activation study visits were included. Statistical analysis was not performed as the sample size is too small to draw any statistically relevant conclusions.

Adverse events

Time frame: From informed consent through completion of study (approximately 3 months). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Enrolled Subjects	0 of 17 (0%)	2 of 17 (11.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chronic Pain

Enrolling by invitation
Efficacy of a Chronic Pain Treatment Prior to Gender-affirming Surgery
Pain Catastrophizing, Pain, Chronic
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
Recruiting
Uncovering the Mechanism of Pain Relief by Peripheral Transcutaneous Magnetic Stimulation
Post-Surgical Pain, Chronic, Post-traumatic Pain, Chronic
Recruiting
Daily Knee Sleeve Use Versus No Use in Older Adults With Chronic Knee Pain
Knee Arthritis, Osteoarthritis

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.

Kristen Lechleiter, M.S. study director

Boston Scientific Neuromodulation Corporation

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

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 1 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 20 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 4 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 19 Jul 2018). 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?

Number of Participants With Paresthesia Coverage ≥50% (time frame: 7, 14 days 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 NCT02384096.

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 Nov 2020.