Failed Back Surgery SyndromeNCT02371122
Spinal Cord Stimulation (SCS) Therapy Study
A study testing Therapy Setting 1 (Medtronic), Therapy Setting 2 (Medtronic) and Therapy Setting 3 (Medtronic) in people with Failed Back Surgery Syndrome and Degenerative Disk Disease, run by MedtronicNeuro.
Trial summary
The purpose of this study is to evaluate the effect of different spinal cord stimulation settings in the treatment of leg pain. Subjects will receive a randomized order of four different programmed stimulation settings for 3 weeks each followed by a fifth and final setting. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Failed Back Surgery Syndrome, Degenerative Disk Disease, Epidural Fibrosis
- What is being tested?
- Therapy Setting 1 (Medtronic), Therapy Setting 2 (Medtronic) and Therapy Setting 3 (Medtronic)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- At least 22 years of age or older at the time of informed consent
- Implanted with a Medtronic RestoreSensor or RestoreUltra SCS system for an on-label indication at least 6 months for the treatment of chronic leg pain, with or without back pain
- Implanted with one or more Medtronic leads located in the epidural space within the thoracic area
- Receiving some level of pain relief with current SCS therapy
- On a stable dose (no new, discontinued or changes in) of all prescription pain medications and willing to maintain or only decrease the dose of all prescribed pain medications
- Read and understand English without assistance
- Willing and able to comply with all study procedures, study visits, and be available for the duration of the study
Who cannot join
- Diagnosed with complex regional pain syndrome (CRPS), peripheral causalgia, or reflex sympathetic dystrophy (RSD), or causalgia
- Has leg, knee, or foot pain unrelated to on-label indication for SCS therapy (for eg, arthritis, knee surgery, etc.)
- Implanted with both a surgical and percutaneous lead
- Implanted with a peripheral lead for subcutaneous or peripheral nerve stimulation
- Has had any of the following procedures:
- Neuroablative procedure within six months
Show all 16Show fewer
- Neurolytic block within two months
- Injection therapy for pain within four weeks
- Sympathetic block within two weeks
- Has an active implanted device (besides RestoreUltra or RestoreSensor neurostimulator), whether turned ON or OFF
- Pregnant or lactating, inadequate birth control, or at risk of pregnancy during this study
- Has an untreated psychiatric comorbidity
- Has serious drug-related behavioral issues
- Has active malignancy or has been diagnosed with cancer and has not been in remission for at least one year
- Has secondary gains which, in the opinion of the investigator, are likely to interfere with the study
- Participating or planning to participate in another clinical trial while enrolled in this study
About this study
The purpose of this study is to evaluate the effect of different spinal cord stimulation settings in the treatment of leg pain. Subjects will receive a randomized order of four different programmed stimulation settings for 3 weeks each followed by a fifth and final setting.
- Conditions
- Failed Back Surgery Syndrome, Degenerative Disk Disease, Epidural Fibrosis, Arachnoiditis, Radiculopathies
- Being tested
- Therapy Setting 1 (Medtronic), Therapy Setting 2 (Medtronic), Therapy Setting 3 (Medtronic), Therapy Setting 4 (Medtronic)
- Medical subject headings
- Failed Back Surgery Syndrome, Arachnoiditis, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapy Setting 1 (Medtronic)Device
RestoreSensor or RestoreUltra Setting 1
Therapy Setting 2 (Medtronic)Device
Medtronic RestoreSensor or RestoreUltra Setting 2
Therapy Setting 3 (Medtronic)Device
Medtronic RestoreSensor or RestoreUltra Setting 3
Therapy Setting 4 (Medtronic)Device
Medtronic RestoreSensor or RestoreUltra Setting 4
| Study group | Role | What they receive |
|---|---|---|
| RestoreSensor or RestoreUltra Setting 1 | Active comparator | Therapy Setting 1 Receives: Device: Therapy Setting 1 (Medtronic) |
| RestoreSensor or RestoreUltra Setting 2 | Active comparator | Therapy Setting 2 Receives: Device: Therapy Setting 2 (Medtronic) |
| RestoreSensor or RestoreUltra Setting 3 | Active comparator | Therapy Setting 3 Receives: Device: Therapy Setting 3 (Medtronic) |
| RestoreSensor or RestoreUltra Setting 4 | Sham comparator | Therapy Setting 4 Receives: Device: Therapy Setting 4 (Medtronic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale - Leg pain
Measured: 12 weeks
Secondary outcomes (5)
Brief Pain Inventory - Pain severity
Measured: 12 weeks
Brief Pain Inventory - Pain interference
Measured: 12 weeks
Quantitative Sensory Testing - Vibration threshold
Measured: 12 weeks
Quantitative Sensory Testing - Electrical stimuli tolerance
Measured: 12 weeks
Numeric Pain Rating Scale - Back pain
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study startJun 2015
- Primary completionNov 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371122
- Sponsor's protocol ID
- 1673
- Status last verified
- Jul 2015
- First submitted
- 19 Feb 2015
- Last updated
- 10 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Stimulation (SCS) Therapy Study
- ClinicalTrials.gov ID
- NCT02371122
- Acronym / sponsor ID
- 1673
- Conditions
- Failed Back Surgery Syndrome, Degenerative Disk Disease, Epidural Fibrosis, Arachnoiditis, Radiculopathies
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 25 Feb 2015 (estimated)
- Results
- Not posted in the source record
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 evaluate the effect of different spinal cord stimulation settings in the treatment of leg pain. Subjects will receive a randomized order of four different programmed stimulation settings for 3 weeks each followed by a fifth and final setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RestoreSensor or RestoreUltra Setting 1 | Active comparator | Device: Therapy Setting 1 (Medtronic)Therapy Setting 1 |
| RestoreSensor or RestoreUltra Setting 2 | Active comparator | Device: Therapy Setting 2 (Medtronic)Therapy Setting 2 |
| RestoreSensor or RestoreUltra Setting 3 | Active comparator | Device: Therapy Setting 3 (Medtronic)Therapy Setting 3 |
| RestoreSensor or RestoreUltra Setting 4 | Sham comparator | Device: Therapy Setting 4 (Medtronic)Therapy Setting 4 |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 22 years of age or older at the time of informed consent
- Implanted with a Medtronic RestoreSensor or RestoreUltra SCS system for an on-label indication at least 6 months for the treatment of chronic leg pain, with or without back pain
- Implanted with one or more Medtronic leads located in the epidural space within the thoracic area
- Receiving some level of pain relief with current SCS therapy
- On a stable dose (no new, discontinued or changes in) of all prescription pain medications and willing to maintain or only decrease the dose of all prescribed pain medications
Key exclusion criteria (16 listed)
- Diagnosed with complex regional pain syndrome (CRPS), peripheral causalgia, or reflex sympathetic dystrophy (RSD), or causalgia
- Has leg, knee, or foot pain unrelated to on-label indication for SCS therapy (for eg, arthritis, knee surgery, etc.)
- Implanted with both a surgical and percutaneous lead
- Implanted with a peripheral lead for subcutaneous or peripheral nerve stimulation
- Has had any of the following procedures:
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 |
|---|---|---|
| Therapy Setting 1 (Medtronic)RestoreSensor or RestoreUltra Setting 1 | Device | RestoreSensor or RestoreUltra Setting 1 |
| Therapy Setting 2 (Medtronic)Medtronic RestoreSensor or RestoreUltra Setting 2 | Device | RestoreSensor or RestoreUltra Setting 2 |
| Therapy Setting 3 (Medtronic)Medtronic RestoreSensor or RestoreUltra Setting 3 | Device | RestoreSensor or RestoreUltra Setting 3 |
| Therapy Setting 4 (Medtronic)Medtronic RestoreSensor or RestoreUltra Setting 4 | Device | RestoreSensor or RestoreUltra Setting 4 |
Primary outcome
Numeric Pain Rating Scale - Leg pain
Time frame: 12 weeks
5 secondary outcomes
Brief Pain Inventory - Pain severity
Time frame: 12 weeks
Brief Pain Inventory - Pain interference
Time frame: 12 weeks
Quantitative Sensory Testing - Vibration threshold
Time frame: 12 weeks
Quantitative Sensory Testing - Electrical stimuli tolerance
Time frame: 12 weeks
Numeric Pain Rating Scale - Back pain
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Therapy Setting 1 (Medtronic), Therapy Setting 2 (Medtronic) and Therapy Setting 3 (Medtronic) in people with Failed Back Surgery Syndrome and Degenerative Disk Disease, run by MedtronicNeuro.
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 16 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: withdrawn, as of the sponsor's last update on 10 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Numeric Pain Rating Scale - Leg pain (time frame: 12 weeks). 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 10 Jul 2015.