Chronic PainNCT02587637
Study to Evaluate the Effectiveness of DRG Stimulation for Discogenic Low Back Pain
A study testing Dorsal root ganglion (DRG) stimulation in people with Chronic Pain, run by Abbott Medical Devices at 1 site in Netherlands.
Trial summary
The purpose of this prospective post market observational pilot study is to evaluate the effect of DRG stimulation in the management of chronic discogenic pain in subjects who are refractory to other available treatments. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Dorsal root ganglion (DRG) stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2015to 30 Jan 2018
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject of either gender between 18 and 65 years of age
- Subject is able and willing to comply with the follow-up schedule and protocol
- Subject is able to provide written informed consent
- Chronic low back pain of at least 6 months
- History consistent with discogenic low back pain (e.g. Pain produced on lumbar motion, significant functional limitation in sitting duration and tolerance)
- Neurologic exam without marked motor deficit.
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- Definite/Highly Probable/Discogenic Pain as confirmed by provocative discography according to IASP/ISIS guidelines*
- Low Back Pain intensity should be 6 or higher measured on a NPRS at baseline
- Meets all the inclusion criteria for the implantation of a neurostimulation system as typically utilised in the study centre
- Subject has been screened by a multi-disciplinary panel including a psychologist and deemed suitable for implantation
Who cannot join
- Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study
- Escalating or changing pain condition within the past month as evidenced by investigator examination
- BMI ≥35
- Subject has had injection therapy or radiofrequency treatment for their low back pain within the past 3 months
- Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump
- Subject is unable to operate the device
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- Severe disc degeneration at the affected level as evidenced by >50% disc height loss on plain anteroposterior and lateral lumbar radiographs or CT/MRI.
- Extruded or sequestered herniated nucleus pulposus at the affected level(s).
- Previous lumbar back surgery (e.g. Laminectomy, discectomy or fusion) at the affected level(s)
- Moderate to severe spinal stenosis due to osteophyte and/or ligamentous overgrowth as evidenced by MRI or CT in the previous 6 months
- Moderate to severe endplate degenerative changes at the affected levels
- Grade 1-2 spondylolisthesis
- Previous Neurostimulation therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Post Market Observational Pilot Study to Evaluate the Effectiveness of DRG Stimulation in the Treatment of Discogenic Low Back Pain
The purpose of this prospective post market observational pilot study is to evaluate the effect of DRG stimulation in the management of chronic discogenic pain in subjects who are refractory to other available treatments. Selected subjects will not be suitable candidates for lumbar spinal surgery and will meet the standard selection process for DRG stimulation as routinely utilised in the study centre. Results from this pilot study will inform current clinical practice and future comparative studies in this specific population.
- Conditions
- Chronic Pain
- Being tested
- Dorsal root ganglion (DRG) stimulation
- Keywords
- Chronic Low Back Pain, Dorsal Root Ganglion, Neurostimulator System, spinal cord stimulation
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dorsal root ganglion (DRG) stimulationDevice
The role the DRG plays in the development and maintenance of chronic pain, we have developed a neurostimulator system for the management of chronic intractable pain by electrically stimulating the DRG
| Study group | Role | What they receive |
|---|---|---|
| Single device arm | Other | Not described Receives: Device: Dorsal root ganglion (DRG) stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With 30% or Greater Reduction in Back Pain at 6 Months
The number (percentage) of subjects who achieve a sustained and clinically meaningful reduction in the intensity of LBP of ≥30% or 2 points on a numerical pain rating scale (NPRS) in the implanted subjects at 6 month follow-up visit as compared to baseline.
Measured: 6 months
Percentage of Subjects With 30% or Greater Reduction in Back Pain at 12 Months
The number (percentage) of subjects who achieve a sustained and clinically meaningful reduction in the intensity of LBP of ≥30% or 2 points on a numerical pain rating scale (NPRS) in the implanted subjects at 12 month follow-up visit as compared to baseline.
Measured: 12 months
Secondary outcomes (4)
Percentage of Patients With Improved Global Impression of Change at 6 Months
The subject was requested to rate their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale (much worse, worse, somewhat worse, no change, slightly better, better and much better). Patients who reported to be much better or better are counted.
Measured: 6 Months
Percentage of Patients With Improved Global Impression of Change at 12 Months Using Trial System
The subject was requested to rate their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale (much worse, worse, somewhat worse, no change, slightly better, better and much better). Patients who reported to be much better or better are counted.
Measured: 12 Months
Percentage of Subjects With 50% or Greater Reduction in Back Pain at 6 Months
Subjects experiencing 50% or more reduction in the intensity of the back pain.
Measured: 6 Months
Percentage of Subjects With 50% or Greater Reduction in Back Pain at 12 Months
Subjects experiencing 50% or more reduction in the intensity of the back pain.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study start1 Oct 2015
- Primary completionDec 2017
- Study completion30 Jan 2018
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 Abbott Medical DevicesThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587637
- Sponsor's protocol ID
- 28-SMI-2015
- Status last verified
- Sep 2024
- First submitted
- 22 Oct 2015
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Post Market Observational Pilot Study to Evaluate the Effectiveness of DRG Stimulation in the Treatment of Discogenic Low Back Pain
- ClinicalTrials.gov ID
- NCT02587637
- Acronym / sponsor ID
- 28-SMI-2015
- Conditions
- Chronic Pain
- Keywords
- Chronic Low Back Pain, Dorsal Root Ganglion, Neurostimulator System, spinal cord stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 27 Oct 2015 (estimated)
- Results
- Posted 19 Sep 2024
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 prospective post market observational pilot study is to evaluate the effect of DRG stimulation in the management of chronic discogenic pain in subjects who are refractory to other available treatments. Selected subjects will not be suitable candidates for lumbar spinal surgery and will meet the standard selection process for DRG stimulation as routinely utilised in the study centre. Results from this pilot study will inform current clinical practice and future comparative studies in this specific population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single device arm | Other | Device: Dorsal root ganglion (DRG) stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject of either gender between 18 and 65 years of age
- Subject is able and willing to comply with the follow-up schedule and protocol
- Subject is able to provide written informed consent
- Chronic low back pain of at least 6 months
- History consistent with discogenic low back pain (e.g. Pain produced on lumbar motion, significant functional limitation in sitting duration and tolerance)
Key exclusion criteria (13 listed)
- Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study
- Escalating or changing pain condition within the past month as evidenced by investigator examination
- BMI ≥35
- Subject has had injection therapy or radiofrequency treatment for their low back pain within the past 3 months
- Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump
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 |
|---|---|---|
| Dorsal root ganglion (DRG) stimulationThe role the DRG plays in the development and maintenance of chronic pain, we have developed a neurostimulator system for the management of chronic intractable pain by electrically stimulating the DRG | Device | Single device arm |
Primary outcome
Percentage of Subjects With 30% or Greater Reduction in Back Pain at 6 Months
Time frame: 6 months
The number (percentage) of subjects who achieve a sustained and clinically meaningful reduction in the intensity of LBP of ≥30% or 2 points on a numerical pain rating scale (NPRS) in the implanted subjects at 6 month follow-up visit as compared to baseline.
Percentage of Subjects With 30% or Greater Reduction in Back Pain at 12 Months
Time frame: 12 months
The number (percentage) of subjects who achieve a sustained and clinically meaningful reduction in the intensity of LBP of ≥30% or 2 points on a numerical pain rating scale (NPRS) in the implanted subjects at 12 month follow-up visit as compared to baseline.
4 secondary outcomes
Percentage of Patients With Improved Global Impression of Change at 6 Months
Time frame: 6 Months
Percentage of Patients With Improved Global Impression of Change at 12 Months Using Trial System
Time frame: 12 Months
Percentage of Subjects With 50% or Greater Reduction in Back Pain at 6 Months
Time frame: 6 Months
Percentage of Subjects With 50% or Greater Reduction in Back Pain at 12 Months
Time frame: 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dorsal root ganglion (DRG) stimulation in people with Chronic Pain, run by Abbott Medical Devices at 1 site in Netherlands.
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 10 inclusion and 13 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 19 Sep 2024. 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 Netherlands. 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 Sep 2024). 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?
Percentage of Subjects With 30% or Greater Reduction in Back Pain at 6 Months (time frame: 6 months). 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?
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 19 Sep 2024.