Chronic PainPhase 4NCT00205868

Spinal Cord Stimulation for Low Back Pain

A Phase 4 study testing Precision Spinal Cord Stimulation System in people with Chronic Pain, run by Boston Scientific Corporation at 30 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

The purpose of this study is to assess the acute and chronic effectiveness of the Advanced Bionics Precision(TM) Spinal Cord Stimulation System in subjects with failed back surgery syndrome and associated low back axial pain. 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?: Precision Spinal Cord Stimulation System
Type of treatment: Medical device
How many people: 304 participants
Where: 30 sitesUnited States
Study dates: Dec 2004to Dec 2007
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

Eligible for spinal cord stimulation as labeled in the FDA approval for the Precision(R) Spinal Cord Stimulator by Advanced Bionics;
Age ≥18 years;
Have pain of neuropathic origin;
Have chronic pain secondary to surgical spine procedure or intractable low back pain with or without leg pain for at least 3 months and not responding to less invasive clinical procedures.

Who cannot join

1. Enrollment in any research that would conflict with study requirements.

Trial locations and contacts

30 sites in 1 country.

City, postcode or hospital

30 sites in 1 country

United States30 sites

Research Center
Allentown, Pennsylvania, 18104
Research Center
Billings, Montana, 59101
Research Center
Bloomington, Illinois, 61701
Research Center
Boston, Massachusetts, 02215
Research Center
Chicago, Illinois, 60611
Research Center
Cudahy, Wisconsin, 53220
Research Center
Cullman, Alabama, 35055
Research Center
Daphne, Alabama, 36526
Research Center
Eugene, Oregon, 97401
Research Center
Hamilton, Ohio, 45011
Research Center
Huntsville, Alabama, 35801
Research Center
Jacksonville, Florida, 32224
Research Center
Jupiter, Florida, 33477
Research Center
Lewiston, Idaho, 83501
Research Center
Los Angeles, California, 90095
Research Center
Merrillville, Indiana, 46410
Research Center
Mesa, Arizona, 85206
Research Center
Murray, Utah, 84107
Research Center
Oak Brook, Illinois, 60707
Research Center
Pasadena, California, 91105
Research Center
Philadelphia, Pennsylvania, 19107
Research Center
Pittsfield, Massachusetts, 01201
Research Center
Provo, Utah, 84604
Research Center
Rice Lake, Wisconsin, 54868
Research Center
Rochester, Minnesota, 55904
Research Center
San Diego, California, 92108
Research Center
Spartanburg, South Carolina, 29302
Research Center
Valparaiso, Indiana, 46410
Research Center
Westminster, Colorado, 80401
Research Center
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: Effectiveness of the Precision Spinal Cord Stimulation System in Patients With Failed Back Surgery Syndrome and Axial Low Back Pain

Subjects will undergo a temporary or permanent trial to assess their candidacy for placement of an implantable pulse generator. Those who demonstrate a significant clinical reduction in pain will be enrolled in the chronic study. Subjects will be followed for 12 months post implantation to assess the long-term effectiveness of the therapy.

Conditions: Chronic Pain
Being tested: Precision Spinal Cord Stimulation System
Keywords: Back Pain, Low Back Pain, Chronic Pain, Spinal Cord Stimulation
Medical subject headings: Chronic Pain, Back Pain, Low Back Pain

What participants receive

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

Precision Spinal Cord Stimulation SystemDevice
Stimulation on throughout study

What is being measured

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

Effectiveness of SCS Stimulation in Reducing Back Pain Associated With Failed Back Surgery Syndrome After 12 Months of Use.
Effectiveness of SCS stimulation in reducing back pain associated with Failed Back Surgery Syndrome after 12 months of use as measured by 0 - 10 numerical rating scale (Numerical Rating Scale, NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine"
Measured: 1 year
Effectiveness of SCS Stimulation in Reducing Leg Pain Associated With Failed Back Surgery Syndrome After 12 Months of Use.
Effectiveness of SCS stimulation in reducing leg pain associated with Failed Back Surgery Syndrome after 12 months of use as measured by 0 - 10 numerical rating scale (Numerical Rating Scale, NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine"
Measured: 1 year

Secondary outcomes (1)

Percentage of Patients Who Achieve a Significant Clinical Reduction in Back Pain Defined as >50% Reduction in VAS Score With Stimulation Compared With no Stimulation
Measured: 1 year

Timeline

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

Dec 2004Dec 2007

First posted21 Sep 2005 (estimated)
Study startDec 2004
Primary completionNov 2007
Study completionDec 2007

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 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 304 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00205868
Sponsor's protocol ID: PM -SCS -120904
Status last verified: May 2021
First submitted: 13 Sep 2005
Last updated: 18 Jun 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

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All Chronic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of the Precision Spinal Cord Stimulation System in Patients With Failed Back Surgery Syndrome and Axial Low Back Pain
ClinicalTrials.gov ID: NCT00205868
Acronym / sponsor ID: PM -SCS -120904
Conditions: Chronic Pain
Keywords: Back Pain, Low Back Pain, Chronic Pain, Spinal Cord Stimulation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 304 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: Dec 2004 (actual)
Primary completion: Nov 2007 (actual)
Study completion: Dec 2007 (actual)
First posted: 21 Sep 2005 (estimated)
Results: Posted 18 Jun 2021

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)

Who may qualify

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

Key inclusion criteria (4 listed)

Eligible for spinal cord stimulation as labeled in the FDA approval for the Precision(R) Spinal Cord Stimulator by Advanced Bionics;
Age ≥18 years;
Have pain of neuropathic origin;
Have chronic pain secondary to surgical spine procedure or intractable low back pain with or without leg pain for at least 3 months and not responding to less invasive clinical procedures.

Key exclusion criteria (1 listed)

1. Enrollment in any research that would conflict with study requirements.

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 Spinal Cord Stimulation SystemStimulation on throughout study	Device	–

Primary outcome

Effectiveness of SCS Stimulation in Reducing Back Pain Associated With Failed Back Surgery Syndrome After 12 Months of Use.
Time frame: 1 year
Effectiveness of SCS stimulation in reducing back pain associated with Failed Back Surgery Syndrome after 12 months of use as measured by 0 - 10 numerical rating scale (Numerical Rating Scale, NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine"
Effectiveness of SCS Stimulation in Reducing Leg Pain Associated With Failed Back Surgery Syndrome After 12 Months of Use.
Time frame: 1 year
Effectiveness of SCS stimulation in reducing leg pain associated with Failed Back Surgery Syndrome after 12 months of use as measured by 0 - 10 numerical rating scale (Numerical Rating Scale, NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine"

1 secondary outcome

Percentage of Patients Who Achieve a Significant Clinical Reduction in Back Pain Defined as >50% Reduction in VAS Score With Stimulation Compared With no Stimulation
Time frame: 1 year

Results and safety

Results posted to the registry on 18 Jun 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
Spinal Cord Stimulation	304	304

Primary outcome: Effectiveness of SCS Stimulation in Reducing Back Pain Associated With Failed Back Surgery Syndrome After 12 Months of Use.

Time frame: 1 year

Population analysed: Efforts were made but the information is not accessible at this time. Hence outcome measures not reported.

Primary outcome: Effectiveness of SCS Stimulation in Reducing Leg Pain Associated With Failed Back Surgery Syndrome After 12 Months of Use.

Time frame: 1 year

Population analysed: Efforts were made but the information is not accessible at this time. Hence outcome measures not reported.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected from enrollment through end of study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Spinal Cord Stimulation	0 of 304 (0%)	0 of 304 (0%)	0 of 304

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chronic Pain

Not yet recruiting
Digital Use, 24-Hour Movement Behaviors, and Myofascial Release in University Students With Neck Pain
Forward Head Posture, Chronic Nonspecific Neck Pain
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Recruiting
Dietary Intervention for Migraine Relief
Migraine
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Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial
Opioid Use Disorder, Chronic Pain
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty

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.

Ramsin Benyamin, MD principal investigator

Millenium Pain Center

30 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 Precision Spinal Cord Stimulation System in people with Chronic Pain, run by Boston Scientific Corporation at 30 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 4 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: finished, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 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.

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 18 Jun 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?

Effectiveness of SCS Stimulation in Reducing Back Pain Associated With Failed Back Surgery Syndrome After 12 Months of Use. (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT00205868.

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 18 Jun 2021.