Low Back PainNCT01550562

Effects of Programming Parameters on Back Pain Relief in Subthreshold Spinal Cord Stimulation

A study testing Boston Scientific Precision Plus spinal cord stimulation therapy in people with Low Back Pain, run by Boston Scientific Corporation at 1 site in Australia.

Terminated

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

Official record

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Trial summary

The purpose of this study is to investigate the effects of varying programming parameters in subthreshold spinal cord stimulation therapy for pain relief. 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?: Boston Scientific Precision Plus spinal cord stimulation therapy
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1 participants
Where: 1 siteAustralia
Study dates: Feb 2012to Apr 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, Ethics Committee-approved informed consent form (ICF) provided in English

Who cannot join

Unable to operate the PrecisionPlus™ 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 previous two exclusion criterion
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 investigational 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 (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 document)

Trial locations and contacts

1 site in 1 country.

Australia1 site

Hunter Pain Clinic
Newcastle, New South Wales, 2292

Other trials in Australia

About this study

Official title: Precision™ High-Rate Sub-perception Spinal Cord Stimulation for the Treatment of Chronic Intractable Pain

The purpose of this study is to investigate the effects of varying programming parameters in subthreshold spinal cord stimulation therapy for pain relief.

Conditions: Low Back Pain
Being tested: Boston Scientific Precision Plus spinal cord stimulation 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.

Boston Scientific Precision Plus spinal cord stimulation therapyDevice
Epidural spinal cord stimulation (SCS) using the Boston Scientific Precision Plus SCS system

Study groups in NCT01550562
Study group	Role	What they receive
Sham Stimulation	Placebo comparator	Sham subthreshold spinal cord stimulation therapy Receives: Device: Boston Scientific Precision Plus spinal cord stimulation therapy
Treatment 1	Active comparator	subthreshold spinal cord stimulation therapy Receives: Device: Boston Scientific Precision Plus spinal cord stimulation therapy
Treatment 2	Experimental	subthreshold spinal cord stimulation therapy Receives: Device: Boston Scientific Precision Plus spinal cord stimulation therapy

What is being measured

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

Pain Relief
Mean within-patient difference in average back pain intensity among treatment groups
Measured: 4,8,and 12 days post temporary lead(s) implantation

Secondary outcomes (5)

Pain Relief Responder Rate
Difference in the proportion of subjects with ≥50% reduction in average back pain intensity among treatment groups
Measured: 4,8,and 12 days post temporary lead(s) implantation
Leg Pain Reduction
Mean within-patient difference in average leg pain intensity among treatment groups
Measured: 4,8,and 12 days post temporary lead(s) implantation
Disability
Mean within-patient difference in disability among treatment groups
Measured: 4,8,and 12 days post temporary lead(s) implantation
Percent Pain Relief
Mean within-patient difference in overall percent pain relief among treatment groups
Measured: 4,8,and 12 days post temporary lead(s) implantation
Quality of Life, as Measured by EQ-5D-5L
Mean within-patient difference in quality of life among treatment groups
Measured: 4,8,and 12 days post temporary lead(s) implantation

Timeline

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

Feb 2012Apr 2013

First posted12 Mar 2012 (estimated)
Study startFeb 2012
Primary completionApr 2013
Study completionApr 2013

Why it stopped: In \>9 months only 1 patient enrolled. Study stopped because design was too cumbersome and subjects not willing to participate

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 Low Back 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: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01550562
Sponsor's protocol ID: A7002
Status last verified: Mar 2021
First submitted: 15 Feb 2012
Last updated: 29 Apr 2021
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

Not yet recruitingPhase 3
Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANT
Chronic Low Back Pain, Musculoskeletal Pain
Not yet recruitingPhase 2
Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain
Chronic Low Back Pain (CLBP), Physical Therapy
Not yet recruiting
Empowering Pain Psychology Access and Collaboration (EPPAC) to Improve Treatment Engagement Among Medicaid-insured Adults With Chronic Low Back Pain
Chronic Low Back Pain (CLBP)
Not yet recruiting
Gamified Home-Based Core Neuromuscular Training for Chronic Low Back Pain
Low Back Pain, Core Muscles
Not yet recruiting
Dual-Task Core Stabilization Training in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low Back Pain

All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Precision™ High-Rate Sub-perception Spinal Cord Stimulation for the Treatment of Chronic Intractable Pain
ClinicalTrials.gov ID: NCT01550562
Acronym / sponsor ID: A7002
Conditions: Low Back Pain
Study type: Interventional
Recruitment status: TerminatedReason stopped: In \>9 months only 1 patient enrolled. Study stopped because design was too cumbersome and subjects not willing to participate
Enrolment: 1 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: Feb 2012 (actual)
Primary completion: Apr 2013 (actual)
Study completion: Apr 2013 (actual)
First posted: 12 Mar 2012 (estimated)
Results: Posted 29 Apr 2021

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 investigate the effects of varying programming parameters in subthreshold spinal cord stimulation therapy for pain relief.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Sham Stimulation	Placebo comparator	Device: Boston Scientific Precision Plus spinal cord stimulation therapySham subthreshold spinal cord stimulation therapy
Treatment 1	Active comparator	Device: Boston Scientific Precision Plus spinal cord stimulation therapysubthreshold spinal cord stimulation therapy
Treatment 2	Experimental	Device: Boston Scientific Precision Plus spinal cord stimulation therapysubthreshold spinal cord stimulation therapy

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 PrecisionPlus™ 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
Boston Scientific Precision Plus spinal cord stimulation therapyEpidural spinal cord stimulation (SCS) using the Boston Scientific Precision Plus SCS system	Device	Sham Stimulation, Treatment 1, Treatment 2

Primary outcome

Pain Relief
Time frame: 4,8,and 12 days post temporary lead(s) implantation
Mean within-patient difference in average back pain intensity among treatment groups

5 secondary outcomes

Pain Relief Responder Rate
Time frame: 4,8,and 12 days post temporary lead(s) implantation
Leg Pain Reduction
Time frame: 4,8,and 12 days post temporary lead(s) implantation
Disability
Time frame: 4,8,and 12 days post temporary lead(s) implantation
Percent Pain Relief
Time frame: 4,8,and 12 days post temporary lead(s) implantation
Quality of Life, as Measured by EQ-5D-5L
Time frame: 4,8,and 12 days post temporary lead(s) implantation

Results and safety

Results posted to the registry on 29 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Randomized	1	1

Primary outcome: Pain Relief

Time frame: 4,8,and 12 days post temporary lead(s) implantation

Population analysed: No study data are available.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Randomized	0 of 1 (0%)	0 of 1 (0%)	0 of 1

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Low Back Pain

Not yet recruitingPhase 3
Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANT
Chronic Low Back Pain, Musculoskeletal Pain
Not yet recruitingPhase 2
Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain
Chronic Low Back Pain (CLBP), Physical Therapy
Not yet recruiting
Empowering Pain Psychology Access and Collaboration (EPPAC) to Improve Treatment Engagement Among Medicaid-insured Adults With Chronic Low Back Pain
Chronic Low Back Pain (CLBP)
Not yet recruiting
Gamified Home-Based Core Neuromuscular Training for Chronic Low Back Pain
Low Back Pain, Core Muscles
Not yet recruiting
Dual-Task Core Stabilization Training in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low Back Pain

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.

Kay Adair 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 Boston Scientific Precision Plus spinal cord stimulation therapy in people with Low Back Pain, run by Boston Scientific Corporation at 1 site in Australia.

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: stopped early, as of the sponsor's last update on 29 Apr 2021. 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 Australia. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Apr 2021). 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?

Pain Relief (time frame: 4,8,and 12 days post temporary lead(s) implantation). 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 NCT01550562.

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 29 Apr 2021; AzTrials last refreshed its copy on 26 Oct 2026.