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PROLONG Prospective, Multi-center, Open-label, Post-market Study (PROLONG)

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ClinicalTrials.gov Identifier: NCT03908476
Recruitment Status : Recruiting
First Posted : April 9, 2019
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Chronic Pain Device: Burst-capable SCS system Device: DRG Stimulator Not Applicable

Detailed Description:

This study will examine the utility of Abbott neurostimulation devices for restoring therapeutic benefit from neuromodulation therapy. These devices include programming the BurstDR waveform in an enabled implantable pulse generator (IPG), and dorsal root ganglion stimulation (Proclaim DRG). The BurstDR waveform offers a unique mechanism of action that may explain why it can restore efficacy where tonic stimulation has failed. While all forms of SCS activate the lateral pain pathway, which is responsible for the sensory aspects of pain, only BurstDR has been shown to activate the medial pain pathway which is responsible for the affective components. It is this medial activation that may allow BurstDR to succeed despite psychological factors such as catastrophizing and depression. Additionally, it is possible that BurstDR may be less susceptible to habituation because it more closely mimics natural thalamic firing.

Several different methods of implementing BurstDR may be included in this investigation to account for a range of possible existing systems and patient needs. It can be implemented by reprogramming a BurstDR-capable device, connecting a BurstDR-capable IPG to existing leads with an adapter or compatible header, or through full system replacement.

While traditional SCS applies stimulation to the dorsal horn of the spinal cord, DRG stimulation targets a bundle of sensory nerve cell bodies just outside of the spinal cord known as the dorsal root ganglion. This form of stimulation has been shown to make it easier to achieve pain-paresthesia overlap, provide consistent stimulation irrespective of body position, and produce paresthesia with a lower current than traditional SCS. Using DRG stimulation as a replacement or supplement to SCS may ensure reliable coverage of the entire painful area and improve pain outcomes.

This is the first prospective investigation designed to evaluate the effectiveness of Abbott neurostimulation devices for restoring pain relief in patients with waning or failed therapy.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PROLONG Prospective, Multi-center, Open-label, Post-market Study
Actual Study Start Date : April 16, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Subjects using BurstDR SCS systems
Spinal cord stimulation with a Burst waveform.
Device: Burst-capable SCS system
Subjects will be given Burst stimulation using a market-released Abbott SCS system. Burst stimulation may be achieved through surgical or non-surgical means.

Experimental: Subjects using DRG systems
Dorsal root ganglion stimulation.
Device: DRG Stimulator
Subjects will be implanted with a market-released Abbott DRG stimulation system.




Primary Outcome Measures :
  1. Change in NRS from baseline to 3 months [ Time Frame: Baseline, 3-months ]
    A scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.

  2. Change in NRS from baseline to 6 months [Time Frame: 6 months] [ Time Frame: Baseline, 6-months ]
    A scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.

  3. Change in NRS from baseline to 12 months [Time Frame: 12 months] [ Time Frame: Baseline, 12-months ]
    A scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.

  4. Change in NRS from baseline to 18 months [ Time Frame: Baseline, 18-months ]
    A scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.

  5. Change in NRS from baseline to 24 months [ Time Frame: Baseline, 24-months ]
    A scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.


Secondary Outcome Measures :
  1. PROMIS-29 [ Time Frame: Baseline, 3, 6, 12, 18, and 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.


  2. Pain Catastrophizing Scale (PCS) [ Time Frame: Baseline, 3, 6, 12, 18, and 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.

  3. Pain Vigilance and Awareness Questionnaire (PVAQ) [ Time Frame: Baseline, 3, 6, 12, 18, and 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.'

  4. Patient Reported Pain Relief [ Time Frame: Up to 1 month ]
    A report of pain relief from 0% to 100%.

  5. Pain condition-related medication use [ Time Frame: Baseline, 3, 6, 12, 18, and 24-months ]
    Details will be collected regarding dosages and categories of pain-related medication.

  6. Therapy-related satisfaction [ Time Frame: Baseline, 3, 6, 12, 18, and 24-months ]

    Patient and Physician Satisfaction. The subject level of satisfaction about the pain relief provided by the therapy, their physical function and the ease of using the device will be assessed using the Likert scale.

    Additionally, physicians will be asked to assess their satisfaction about the therapy, the physical and mental health of the subject, and the ease of using the device. the Likert scale will be used for this assessment.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient must provide written informed consent prior to any clinical investigation related procedure.
  2. Patient has a spinal cord stimulator implanted for chronic, intractable pain.
  3. Patient has inadequate pain relief from their current SCS system.
  4. Patient has a pain NRS ≥ 6.
  5. Physician has determined that the patient's original pain is still addressable with neurostimulation.

Exclusion Criteria:

  1. Patient is enrolled, or intends to participate, in a competing clinical study, as determined by Abbott.
  2. Patient is seeking care for a new pain complaint outside of the original indication for SCS.
  3. 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.
  4. Physician has determined that patient's pain relief is inadequate due to a malfunction or damage to the existing system.
  5. Patient requires frequent MRI.
  6. Patient is involved in active disability litigation related to their pain or seeking worker's compensation.
  7. Patient is part of a vulnerable population.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03908476


Contacts
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Contact: Robyn Capobianco +15122864274 robyn.capobianco@abbott.com
Contact: Nicole Harbert +1 972 526 4841 nicole.harbert@abbott.com

Locations
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United States, California
Spanish Hills Interventional Pain Specialists Recruiting
Camarillo, California, United States, 93010
Contact: Patrick Buchanan, MD       buchanan07030@gmail.com   
United States, New York
Ainsworth Institute of Pain Management Recruiting
New York, New York, United States, 10022
Contact: Corey Hunter, MD       chunter@ainpain.com   
United States, Pennsylvania
Center for Interventional Pain and Spine Recruiting
Lancaster, Pennsylvania, United States, 17601
Contact: Steven Falowski, MD       sfalowski@gmail.com   
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Director: Robyn Capobianco Abbott

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03908476     History of Changes
Other Study ID Numbers: ABT-CIP-10277
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms