Chronic PainPROLONGNCT03908476
PROLONG Prospective, Multi-center, Open-label, Post-market Study
A study testing Burst-capable SCS system and DRG Stimulator in people with Chronic Pain, run by Abbott Medical Devices at 21 sites in United States.
Trial summary
Spinal cord stimulation (SCS) has been shown to be effective for relieving intractable chronic pain. However, a portion of patients who initially succeed with SCS will eventually lose their therapeutic benefit. 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?
- Burst-capable SCS system and DRG Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 21 sitesUnited States
- Study dates
- 16 Apr 2019to 15 Nov 2021
- 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
- Patient must provide written informed consent prior to any clinical investigation related procedure.
- Patient has a spinal cord stimulator implanted for chronic, intractable pain.
- Patient has inadequate pain relief from their current SCS system.
- Patient has a pain NRS ≥ 6.
- Physician has determined that the patient's original pain is still addressable with neurostimulation.
Who cannot join
- Patient is enrolled, or intends to participate, in a competing clinical study, as determined by Abbott.
- Patient is seeking care for a new pain complaint outside of the original indication for SCS.
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the Investigator's opinion, could limit the patient's ability to participate in the clinical investigation or to comply with follow-up requirements.
- Physician has determined that patient's pain relief is inadequate due to a malfunction or damage to the existing system.
- Patient requires frequent MRI.
- Patient is involved in active disability litigation related to their pain or seeking worker's compensation.
- Patient is part of a vulnerable population.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Albany Medical College at Albany Medical Center
Albany, New York, 12208
Northwest Brain & Spine
Bend, Oregon, 97701
Boca Raton Regional Hospital
Boca Raton, Florida, 33486
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Spanish Hills Interventional Pain Specialists
Camarillo, California, 93010
Coastal Pain & Spinal Diagnostics Medical Group
Carlsbad, California, 92009
The Spine & Nerve Center of St. Francis Hospital
Charleston, West Virginia, 25301
Garden State Pain Control
Clifton, New Jersey, 07013
Nura
Edina, Minnesota, 55435
Front Range Pain Medicine
Fort Collins, Colorado, 80528
St. Mary's Hospital
Huntington, West Virginia, 25702
UC San Diego Center for Pain Medicine
La Jolla, California, 92037
Center for Interventional Pain and Spine
Lancaster, Pennsylvania, 17604
Napa Valley Orthopedic Medical Group
Napa, California, 94558
Ainsworth Institute of Pain Management
New York, New York, 10022
Newport Beach Headache & Pain
Newport Beach, California, 92660
Allegheny General Hospital Department of Neurosurgery
Pittsburgh, Pennsylvania, 15212
Nevada Advanced Pain Specialists
Reno, Nevada, 89511
Spine & Nerve Diagnostic Center
Roseville, California, 95661
Pacific Research Institute
San Francisco, California, 94104
Pain Care, LLC
Stockbridge, Georgia, 30281
About this study
Spinal cord stimulation (SCS) has been shown to be effective for relieving intractable chronic pain. However, a portion of patients who initially succeed with SCS will eventually lose their therapeutic benefit. Reliable methods have not been identified for restoring neuromodulation benefit to this underserved population, so additional research is required. This study will prospectively observe subjects who utilize Abbott neurostimulation devices after failing to sustain pain relief with their previous SCS system. The effectiveness of Abbott systems in restoring neuromodulation benefit will be evaluated over the course of a two-year follow-up.
- Conditions
- Chronic Pain
- Being tested
- Burst-capable SCS system, DRG Stimulator
- Keywords
- Chronic Pain, Spinal cord stimulation, ABT-CIP-10277, BurstDR, SCS, DRG
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Burst-capable SCS systemDevice
Subjects will be given Burst stimulation using a market-released Abbott SCS system. Burst stimulation may be achieved through surgical or non-surgical means.
DRG StimulatorDevice
Subjects will be implanted with a market-released Abbott DRG stimulation system.
| Study group | Role | What they receive |
|---|---|---|
| Subjects using BurstDR SCS systems | Experimental | Spinal cord stimulation with a Burst waveform. Receives: Device: Burst-capable SCS system |
| Subjects using DRG systems | Experimental | Dorsal root ganglion stimulation. Receives: Device: DRG Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 3 Months
Numerical Rating Scale (NRS) is a scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.
Measured: From Baseline to 3 months
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 6 Months
Numerical Rating Scale (NRS) is a scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.
Measured: From Baseline to 6 months
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 12 Months
Numerical Rating Scale (NRS) is a scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.
Measured: From Baseline to 12 months
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 18 Months
Numerical Rating Scale (NRS) is a scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.
Measured: From Baseline to 18 months
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 24 Months
Numerical Rating Scale (NRS) is a scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.
Measured: From Baseline to 24 months
Secondary outcomes (20)
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 3 Months
Patient Reported Outcomes Measurement Information System Adult Profile The PROMIS-29 is a 29-item profile instrument that covers 7 health domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and social function) with 4 questions each. The final item is an 11-point pain intensity numerical rating scale (NRS). Subjects should read each item and check the one box that most closely represents their response.
Each item is scored on a scale from 1-5 with total scores for each domain ranging from 4-20. Greater scores represent more of whatever concept is being measured (e.g., depression or physical function). The scoring tables have been provided in the measure manual. Raw domain scores are converted to t-scores with a mean of 50 and a standard deviation of 10. The t-scores were validated on a sample from the general population and all items must be answered to utilize the scoring tables.
Measured: From baseline to 3 months
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 6 Months
Patient Reported Outcomes Measurement Information System Adult Profile The PROMIS-29 is a 29-item profile instrument that covers 7 health domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and social function) with 4 questions each. The final item is an 11-point pain intensity numerical rating scale (NRS). Subjects should read each item and check the one box that most closely represents their response.
Each item is scored on a scale from 1-5 with total scores for each domain ranging from 4-20. Greater scores represent more of whatever concept is being measured (e.g., depression or physical function). The scoring tables have been provided in the measure manual. Raw domain scores are converted to t-scores with a mean of 50 and a standard deviation of 10. The t-scores were validated on a sample from the general population and all items must be answered to utilize the scoring tables.
Measured: From baseline to 6 months
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 12 Months
Patient Reported Outcomes Measurement Information System Adult Profile The PROMIS-29 is a 29-item profile instrument that covers 7 health domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and social function) with 4 questions each. The final item is an 11-point pain intensity numerical rating scale (NRS). Subjects should read each item and check the one box that most closely represents their response.
Each item is scored on a scale from 1-5 with total scores for each domain ranging from 4-20. Greater scores represent more of whatever concept is being measured (e.g., depression or physical function). The scoring tables have been provided in the measure manual. Raw domain scores are converted to t-scores with a mean of 50 and a standard deviation of 10. The t-scores were validated on a sample from the general population and all items must be answered to utilize the scoring tables.
Measured: From baseline to 12 months
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 18 Months
Patient Reported Outcomes Measurement Information System Adult Profile The PROMIS-29 is a 29-item profile instrument that covers 7 health domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and social function) with 4 questions each. The final item is an 11-point pain intensity numerical rating scale (NRS). Subjects should read each item and check the one box that most closely represents their response.
Each item is scored on a scale from 1-5 with total scores for each domain ranging from 4-20. Greater scores represent more of whatever concept is being measured (e.g., depression or physical function). The scoring tables have been provided in the measure manual. Raw domain scores are converted to t-scores with a mean of 50 and a standard deviation of 10. The t-scores were validated on a sample from the general population and all items must be answered to utilize the scoring tables.
Measured: From baseline to 18 months
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 24 Months
Patient Reported Outcomes Measurement Information System Adult Profile The PROMIS-29 is a 29-item profile instrument that covers 7 health domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and social function) with 4 questions each. The final item is an 11-point pain intensity numerical rating scale (NRS). Subjects should read each item and check the one box that most closely represents their response.
Each item is scored on a scale from 1-5 with total scores for each domain ranging from 4-20. Greater scores represent more of whatever concept is being measured (e.g., depression or physical function). The scoring tables have been provided in the measure manual. Raw domain scores are converted to t-scores with a mean of 50 and a standard deviation of 10. The t-scores were validated on a sample from the general population and all items must be answered to utilize the scoring tables.
Measured: From baseline to 24 months
Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 3 Months
The PCS is a validated, 13-item scale that evaluates 3 domains of pain-related negative thoughts (rumination, magnification, and helplessness). Subjects rate how often they have the given thought from 0 "not at all" to 4 "all the time". The total score is a sum of all responses, ranging from 0-52. Each domain has a sub-scale score calculated as a sum of the constituent responses with ranges of 0-16 for rumination, 0-12 for magnification, and 0-24 for helplessness.
Measured: From baseline to 3 months
Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 6 Months
The PCS is a validated, 13-item scale that evaluates 3 domains of pain-related negative thoughts (rumination, magnification, and helplessness). Subjects rate how often they have the given thought from 0 "not at all" to 4 "all the time". The total score is a sum of all responses, ranging from 0-52. Each domain has a sub-scale score calculated as a sum of the constituent responses with ranges of 0-16 for rumination, 0-12 for magnification, and 0-24 for helplessness.
Measured: From baseline to 6 months
Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 12 Months
The PCS is a validated, 13-item scale that evaluates 3 domains of pain-related negative thoughts (rumination, magnification, and helplessness). Subjects rate how often they have the given thought from 0 "not at all" to 4 "all the time". The total score is a sum of all responses, ranging from 0-52. Each domain has a sub-scale score calculated as a sum of the constituent responses with ranges of 0-16 for rumination, 0-12 for magnification, and 0-24 for helplessness.
Measured: From baseline to 12 months
Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 18 Months
The PCS is a validated, 13-item scale that evaluates 3 domains of pain-related negative thoughts (rumination, magnification, and helplessness). Subjects rate how often they have the given thought from 0 "not at all" to 4 "all the time". The total score is a sum of all responses, ranging from 0-52. Each domain has a sub-scale score calculated as a sum of the constituent responses with ranges of 0-16 for rumination, 0-12 for magnification, and 0-24 for helplessness.
Measured: From baseline to 18 months
Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 24 Months
The PCS is a validated, 13-item scale that evaluates 3 domains of pain-related negative thoughts (rumination, magnification, and helplessness). Subjects rate how often they have the given thought from 0 "not at all" to 4 "all the time". The total score is a sum of all responses, ranging from 0-52. Each domain has a sub-scale score calculated as a sum of the constituent responses with ranges of 0-16 for rumination, 0-12 for magnification, and 0-24 for helplessness.
Measured: From baseline to 24 months
Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 3 Months
'The PVAQ is a validated, 16-item scale that evaluates attention to pain. Subjects rate how frequently each statement represents their experience over the last 2 weeks from 0 "never" to 5 "always". Item scores are summed to produce the total score, which ranges from 0-80 with a higher score indicating greater attention to pain.'
Measured: From baseline to 3 months
Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 6 Months
'The PVAQ is a validated, 16-item scale that evaluates attention to pain. Subjects rate how frequently each statement represents their experience over the last 2 weeks from 0 "never" to 5 "always". Item scores are summed to produce the total score, which ranges from 0-80 with a higher score indicating greater attention to pain.'
Measured: From baseline to 6 months
Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 12 Months
'The PVAQ is a validated, 16-item scale that evaluates attention to pain. Subjects rate how frequently each statement represents their experience over the last 2 weeks from 0 "never" to 5 "always". Item scores are summed to produce the total score, which ranges from 0-80 with a higher score indicating greater attention to pain.'
Measured: From baseline to 12 months
Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 18 Months
'The PVAQ is a validated, 16-item scale that evaluates attention to pain. Subjects rate how frequently each statement represents their experience over the last 2 weeks from 0 "never" to 5 "always". Item scores are summed to produce the total score, which ranges from 0-80 with a higher score indicating greater attention to pain.'
Measured: From baseline to 18 months
Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 24 Months
'The PVAQ is a validated, 16-item scale that evaluates attention to pain. Subjects rate how frequently each statement represents their experience over the last 2 weeks from 0 "never" to 5 "always". Item scores are summed to produce the total score, which ranges from 0-80 with a higher score indicating greater attention to pain.'
Measured: From baseline to 24 months
Change in Pain Condition-related Medication Use From Baseline to 3 Months
Details will be collected regarding dosages and categories of pain-related medication.
Measured: From baseline to 3 months
Change in Pain Condition-related Medication Use From Baseline to 6 Months
Details will be collected regarding dosages and categories of pain-related medication.
Measured: From baseline to 6 months
Change in Pain Condition-related Medication Use From Baseline to 12 Months
Details will be collected regarding dosages and categories of pain-related medication.
Measured: From baseline to 12 months
Change in Pain Condition-related Medication Use From Baseline to 18 Months
Details will be collected regarding dosages and categories of pain-related medication.
Measured: From baseline to 18 months
Change in Pain Condition-related Medication Use From Baseline to 24 Months
Details will be collected regarding dosages and categories of pain-related medication.
Measured: From baseline to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start16 Apr 2019
- Primary completion15 Nov 2021
- Study completion15 Nov 2021
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marie Fahey, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908476
- Sponsor's protocol ID
- ABT-CIP-10277
- Acronym
- PROLONG
- Status last verified
- Jul 2023
- First submitted
- 13 Mar 2019
- Last updated
- 1 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROLONG Prospective, Multi-center, Open-label, Post-market Study
- ClinicalTrials.gov ID
- NCT03908476
- Acronym / sponsor ID
- PROLONG / ABT-CIP-10277
- Conditions
- Chronic Pain
- Keywords
- Chronic Pain, Spinal cord stimulation, ABT-CIP-10277, BurstDR, SCS, DRG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 9 Apr 2019 (actual)
- Results
- Posted 25 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Spinal cord stimulation (SCS) has been shown to be effective for relieving intractable chronic pain. However, a portion of patients who initially succeed with SCS will eventually lose their therapeutic benefit. Reliable methods have not been identified for restoring neuromodulation benefit to this underserved population, so additional research is required. This study will prospectively observe subjects who utilize Abbott neurostimulation devices after failing to sustain pain relief with their previous SCS system. The effectiveness of Abbott systems in restoring neuromodulation benefit will be evaluated over the course of a two-year follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects using BurstDR SCS systems | Experimental | Device: Burst-capable SCS systemSpinal cord stimulation with a Burst waveform. |
| Subjects using DRG systems | Experimental | Device: DRG StimulatorDorsal root ganglion stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient must provide written informed consent prior to any clinical investigation related procedure.
- Patient has a spinal cord stimulator implanted for chronic, intractable pain.
- Patient has inadequate pain relief from their current SCS system.
- Patient has a pain NRS ≥ 6.
- Physician has determined that the patient's original pain is still addressable with neurostimulation.
Key exclusion criteria (7 listed)
- Patient is enrolled, or intends to participate, in a competing clinical study, as determined by Abbott.
- Patient is seeking care for a new pain complaint outside of the original indication for SCS.
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the Investigator's opinion, could limit the patient's ability to participate in the clinical investigation or to comply with follow-up requirements.
- Physician has determined that patient's pain relief is inadequate due to a malfunction or damage to the existing system.
- Patient requires frequent MRI.
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 |
|---|---|---|
| Burst-capable SCS systemSubjects will be given Burst stimulation using a market-released Abbott SCS system. Burst stimulation may be achieved through surgical or non-surgical means. | Device | Subjects using BurstDR SCS systems |
| DRG StimulatorSubjects will be implanted with a market-released Abbott DRG stimulation system. | Device | Subjects using DRG systems |
Primary outcome
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 3 Months
Time frame: From Baseline to 3 months
Numerical Rating Scale (NRS) is a scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 6 Months
Time frame: From Baseline to 6 months
Numerical Rating Scale (NRS) is a scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 12 Months
Time frame: From Baseline to 12 months
Numerical Rating Scale (NRS) is a scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 18 Months
Time frame: From Baseline to 18 months
Numerical Rating Scale (NRS) is a scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 24 Months
Time frame: From Baseline to 24 months
Numerical Rating Scale (NRS) is a scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.
20 secondary outcomes
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 3 Months
Time frame: From baseline to 3 months
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 6 Months
Time frame: From baseline to 6 months
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 12 Months
Time frame: From baseline to 12 months
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 18 Months
Time frame: From baseline to 18 months
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 24 Months
Time frame: From baseline to 24 months
Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 3 Months
Time frame: From baseline to 3 months
Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 6 Months
Time frame: From baseline to 6 months
Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 12 Months
Time frame: From baseline to 12 months
Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 18 Months
Time frame: From baseline to 18 months
Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 24 Months
Time frame: From baseline to 24 months
Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 3 Months
Time frame: From baseline to 3 months
Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 6 Months
Time frame: From baseline to 6 months
Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 12 Months
Time frame: From baseline to 12 months
Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 18 Months
Time frame: From baseline to 18 months
Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 24 Months
Time frame: From baseline to 24 months
Change in Pain Condition-related Medication Use From Baseline to 3 Months
Time frame: From baseline to 3 months
Change in Pain Condition-related Medication Use From Baseline to 6 Months
Time frame: From baseline to 6 months
Change in Pain Condition-related Medication Use From Baseline to 12 Months
Time frame: From baseline to 12 months
Change in Pain Condition-related Medication Use From Baseline to 18 Months
Time frame: From baseline to 18 months
Change in Pain Condition-related Medication Use From Baseline to 24 Months
Time frame: From baseline to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- 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.
Marie Fahey study director
Abbott
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Burst-capable SCS system and DRG Stimulator in people with Chronic Pain, run by Abbott Medical Devices at 21 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 5 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: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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 25 Jan 2023). 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?
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 3 Months (time frame: From Baseline to 3 months). The study lists 5 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 1 Aug 2023.