Failed Back Surgery SyndromeSubQStimNCT01818297
Subcutaneous Nerve Stimulation for Failed Back Surgery Syndrome (FBSS) Patients
A study testing PrimeAdvanced® neurostimulator system in people with Failed Back Surgery Syndrome and Post-laminectomy Syndrome, run by MedtronicNeuro at 27 sites in United States.
Trial summary
The purpose of this study is to assess the safety and efficacy of Subcutaneous Nerve Stimulation (SQS) (also known as Peripheral Nerve Stimulation [PNS]) in the reduction of chronic, intractable post-surgical back pain in adults. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Failed Back Surgery Syndrome, Post-laminectomy Syndrome
- What is being tested?
- PrimeAdvanced® neurostimulator system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 27 sitesUnited States
- Study dates
- Apr 2013to Mar 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have persistent back pain for at least 6 months
- Had back surgery at least 6 months ago
- Have tried pain medications and physical therapy
- Read and understand written English or Spanish
- Male or non-pregnant female. If female of child-bearing potential, and if sexually active, must be using a medically-acceptable method of birth control during study participation
- Willing and able to undergo surgical implant procedure, attend visits as scheduled, and comply with the study requirements
- Have an expected lifespan greater than 12 months
Who cannot join
- Have leg pain in addition to back pain.
- Currently enrolled in or plan to enroll in another drug and/or device study
- Have peripheral vascular disease, peripheral neuropathy, small-fiber neuropathy, or fibromyalgia
- Have an active systemic infection or are immunocompromised
- Will be exposed to diathermy or anticipate needing a full-body MRI scan
- Currently have an implantable cardiac pacemaker, defibrillator, or neurostimulator
- Treated with spinal cord stimulation, peripheral nerve stimulation, an intrathecal drug delivery system or requires additional back surgery
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Emory University School of Medicine
Atlanta, Georgia, 30322
Coastal Pain Research
Carlsbad, California, 92009
Austin Pain Associates
Cedar Park, Texas, 78613
Rush University Medical Center
Chicago, Illinois, 60612
University of Illinois at Chicago
Chicago, Illinois, 60612
Mayfield Clinic
Cincinnati, Ohio, 45219
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Columbia Interventional Pain Center, LLP
Columbia, Missouri, 65201
Ohio State University
Columbus, Ohio, 43210
Summa Western Reserve Hospital
Cuyahoga Falls, Ohio, 44223
Pain Medicine Associates
Fountain Valley, California, 92708
Wisconsin Health Center Surgery Center
Greenfield, Wisconsin, 53220
DNA Advanced Pain Treatment Center
Greensburg, Pennsylvania, 15601
University of Kansas Medical Center
Kansas City, Kansas, 66160
Florida Pain Institute
Merritt Island, Florida, 32953
Advanced Medicine and Pain Management Research
Miami, Florida, 33145
Southern Spine Institute
Mt. Pleasant, South Carolina, 29464
NYU Langone Medical Center
New York, New York, 10016
Compass Research, LLC
Orlando, Florida, 32806
Comprehensive Pain and Rehabilitation
Pascagoula, Mississippi, 39581
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Valley Pain Consultants
Phoenix, Arizona, 85001
HOPE Research Institute
Phoenix, Arizona, 85018
Lifetree Clinical Research
Salt Lake City, Utah, 84106
Willis Knighton River Cities Clinical Research Center
Shreveport, Louisiana, 71105
Mercy Medical Research Institute
Springfield, Missouri, 65804
Space City Pain Specialists
Webster, Texas, 77598
About this study
Official title: SubQStim Pivotal Study: A Prospective, Randomized, Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Nerve Stimulation. Protocol 1666
The purpose of this study is to assess the safety and efficacy of Subcutaneous Nerve Stimulation (SQS) (also known as Peripheral Nerve Stimulation [PNS]) in the reduction of chronic, intractable post-surgical back pain in adults.
Read the detailed description
This study is a multi-center, prospective, randomized (1:1) parallel-group design.
- Being tested
- PrimeAdvanced® neurostimulator system
- Medical subject headings
- Failed Back Surgery Syndrome, post laminectomy syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrimeAdvanced® neurostimulator systemDevice
Neurostimulator and associated components
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | Treatment settings of Medtronic PrimeAdvanced® neurostimulator system implant Receives: Device: PrimeAdvanced® neurostimulator system |
| Control | Other | Control settings of Medtronic PrimeAdvanced® neurostimulator system implant Receives: Device: PrimeAdvanced® neurostimulator system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Back Pain Responders (Subjects Who Achieve at Least a 50% Reduction in Average Back Pain With no Increase in Prescription Pain Medications) From Baseline to Month 3 Post-device Activation.
Number of responders in Treatment and Control groups. Subjects reported typical back pain (0=no pain, 10=worst pain) during the Baseline (BL) and Blinded Phase (M3) periods. Percentage reduction in average back pain was calculated as (BL-M3)/BL. Subjects with at least a 50% reduction in average back pain between Baseline and Month 3, with no increase in prescribed pain medications, were considered responders.
Measured: Baseline to 3 months
Secondary outcomes (5)
Functional Disability
Compare the difference in average improvement in disability (as measured by Oswestry Disability Index (ODI)) from Baseline to Month 3 between the Treatment and Control groups. ODI ranges from 0% (no disability) -100% (greatest disability). Change is calculated as Baseline - Month 3 with a positive change indicating improvement in disability. Subjects with missing Baseline and/or Month 3 ODI assessments were counted as no change (Baseline - Month 3 = 0).
Measured: Baseline to 3 months
Subject Satisfaction
Compare difference in number of subjects satisfied with therapy between the Treatment and Control groups at Month 3. Subjects who reported they were very or somewhat satisfied with the therapy were counted as satisfied. Subjects with no satisfaction response were excluded from the analysis.
Measured: 3 months
Quality of Life: Physical
Compare the average change in quality of life (as measured by Short Form Health Survey (SF36 v2): Physical component score (PCS)) from Baseline to Month 3 between subjects in the Treatment and Control groups. The PCS ranges from 0 (worst possible physicial quality of life) to 100 (best possible physical quality of life). Change was calculated as Month 3 - Baseline, with a positive difference indicating improvement in physical quality of life. Subjects with missing Baseline and/or Month 3 SF-36: PCS assessments were counted as no change (Month 3 - Baseline = 0).
Measured: Baseline to 3 months
Quality of Life: Mental
Compare the average change in quality of life (as measured by Short Form Health Survey (SF36 v2): Mental component score (MCS)) from Baseline to Month 3 between subjects in the Treatment and Control groups. The MCS ranges from 0 (worst possible mental quality of life) to 100 (best possible mental quality of life). Change was calculated as Month 3 - Baseline, with a positive difference indicating improvement in mental quality of life. Subjects with missing Baseline and/or Month 3 SF-36: MCS assessments were counted as no change (Month 3 - Baseline = 0).
Measured: Baseline to 3 months
Worst Back Pain
Compare the average improvement in worst back pain from Baseline to Month 3 between the Treatment and Control groups. Subjects reported worst back pain (0 (no pain) - 10 (worst pain)) during the Baseline and Blinded Phase (Month 3) periods. Change was calculated as Baseline - Month 3, with a positive change indicating improvement in worst back pain.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: Sponsor decision
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 Failed Back Surgery SyndromeStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George Mandybur, MD, Principal investigator, Mayfield Clinic, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818297
- Sponsor's protocol ID
- 1666
- Other IDs
- G120146
- Acronym
- SubQStim
- Status last verified
- Sep 2017
- First submitted
- 21 Mar 2013
- Last updated
- 21 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SubQStim Pivotal Study: A Prospective, Randomized, Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Nerve Stimulation. Protocol 1666
- ClinicalTrials.gov ID
- NCT01818297
- Acronym / sponsor ID
- SubQStim / 1666
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 137 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 26 Mar 2013 (estimated)
- Results
- Posted 21 Sep 2017
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 assess the safety and efficacy of Subcutaneous Nerve Stimulation (SQS) (also known as Peripheral Nerve Stimulation [PNS]) in the reduction of chronic, intractable post-surgical back pain in adults.
Detailed description
This study is a multi-center, prospective, randomized (1:1) parallel-group design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Device: PrimeAdvanced® neurostimulator systemTreatment settings of Medtronic PrimeAdvanced® neurostimulator system implant |
| Control | Other | Device: PrimeAdvanced® neurostimulator systemControl settings of Medtronic PrimeAdvanced® neurostimulator system implant |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have persistent back pain for at least 6 months
- Had back surgery at least 6 months ago
- Have tried pain medications and physical therapy
- Read and understand written English or Spanish
- Male or non-pregnant female. If female of child-bearing potential, and if sexually active, must be using a medically-acceptable method of birth control during study participation
Key exclusion criteria (7 listed)
- Have leg pain in addition to back pain.
- Currently enrolled in or plan to enroll in another drug and/or device study
- Have peripheral vascular disease, peripheral neuropathy, small-fiber neuropathy, or fibromyalgia
- Have an active systemic infection or are immunocompromised
- Will be exposed to diathermy or anticipate needing a full-body MRI scan
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 |
|---|---|---|
| PrimeAdvanced® neurostimulator systemNeurostimulator and associated components | Device | Control, Treatment |
Primary outcome
Number of Back Pain Responders (Subjects Who Achieve at Least a 50% Reduction in Average Back Pain With no Increase in Prescription Pain Medications) From Baseline to Month 3 Post-device Activation.
Time frame: Baseline to 3 months
Number of responders in Treatment and Control groups. Subjects reported typical back pain (0=no pain, 10=worst pain) during the Baseline (BL) and Blinded Phase (M3) periods. Percentage reduction in average back pain was calculated as (BL-M3)/BL. Subjects with at least a 50% reduction in average back pain between Baseline and Month 3, with no increase in prescribed pain medications, were considered responders.
5 secondary outcomes
Functional Disability
Time frame: Baseline to 3 months
Subject Satisfaction
Time frame: 3 months
Quality of Life: Physical
Time frame: Baseline to 3 months
Quality of Life: Mental
Time frame: Baseline to 3 months
Worst Back Pain
Time frame: Baseline to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
George Mandybur, MD principal investigator
Mayfield Clinic, University of Cincinnati
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrimeAdvanced® neurostimulator system in people with Failed Back Surgery Syndrome and Post-laminectomy Syndrome, run by MedtronicNeuro at 27 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 7 inclusion and 7 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 21 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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 21 Sep 2017). 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 Back Pain Responders (Subjects Who Achieve at Least a 50% Reduction in Average Back Pain With no Increase in Prescription Pain Medications) From Baseline to Month 3 Post-device Activation. (time frame: Baseline to 3 months). 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 21 Sep 2017.