Clinical trial NCT03908476: PROLONG Prospective, Multi-center, Open-label, Post-market Study
Official title: PROLONG Prospective, Multi-center, Open-label, Post-market Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic Pain
Spinal cord stimulation
ABT-CIP-10277
BurstDR
SCS
DRG
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2019-04-09
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 3 Months
timeFrame: From Baseline to 3 months
measure: Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 6 Months
timeFrame: From Baseline to 6 months
measure: Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 12 Months
timeFrame: From Baseline to 12 months
measure: Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 18 Months
timeFrame: From Baseline to 18 months
measure: Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 24 Months
timeFrame: From Baseline to 24 months
Secondary outcomes:
measure: Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 3 Months
timeFrame: From baseline to 3 months
measure: Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 6 Months
timeFrame: From baseline to 6 months
measure: Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 12 Months
timeFrame: From baseline to 12 months
measure: Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 18 Months
timeFrame: From baseline to 18 months
measure: Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 24 Months
timeFrame: From baseline to 24 months
measure: Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 3 Months
timeFrame: From baseline to 3 months
measure: Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 6 Months
timeFrame: From baseline to 6 months
measure: Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 12 Months
timeFrame: From baseline to 12 months
measure: Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 18 Months
timeFrame: From baseline to 18 months
measure: Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 24 Months
timeFrame: From baseline to 24 months
measure: Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 3 Months
timeFrame: From baseline to 3 months
measure: Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 6 Months
timeFrame: From baseline to 6 months
measure: Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 12 Months
timeFrame: From baseline to 12 months
measure: Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 18 Months
timeFrame: From baseline to 18 months
measure: Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 24 Months
timeFrame: From baseline to 24 months
measure: Change in Pain Condition-related Medication Use From Baseline to 3 Months
timeFrame: From baseline to 3 months
measure: Change in Pain Condition-related Medication Use From Baseline to 6 Months
timeFrame: From baseline to 6 months
measure: Change in Pain Condition-related Medication Use From Baseline to 12 Months
timeFrame: From baseline to 12 months
measure: Change in Pain Condition-related Medication Use From Baseline to 18 Months
timeFrame: From baseline to 18 months
measure: Change in Pain Condition-related Medication Use From Baseline to 24 Months
timeFrame: From baseline to 24 months
Other outcomes:
Locations:
city: Camarillo
country: United States
facility: Spanish Hills Interventional Pain Specialists
state: California
city: Carlsbad
country: United States
facility: Coastal Pain & Spinal Diagnostics Medical Group
state: California
city: La Jolla
country: United States
facility: UC San Diego Center for Pain Medicine
state: California
city: Napa
country: United States
facility: Napa Valley Orthopedic Medical Group
state: California
city: Newport Beach
country: United States
facility: Newport Beach Headache & Pain
state: California
city: Roseville
country: United States
facility: Spine & Nerve Diagnostic Center
state: California
city: San Francisco
country: United States
facility: Pacific Research Institute
state: California
city: Fort Collins
country: United States
facility: Front Range Pain Medicine
state: Colorado
city: Boca Raton
country: United States
facility: Boca Raton Regional Hospital
state: Florida
city: Stockbridge
country: United States
facility: Pain Care, LLC
state: Georgia
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Edina
country: United States
facility: Nura
state: Minnesota
city: Reno
country: United States
facility: Nevada Advanced Pain Specialists
state: Nevada
city: Clifton
country: United States
facility: Garden State Pain Control
state: New Jersey
city: Albany
country: United States
facility: Albany Medical College at Albany Medical Center
state: New York
city: New York
country: United States
facility: Ainsworth Institute of Pain Management
state: New York
city: Bend
country: United States
facility: Northwest Brain & Spine
state: Oregon
city: Lancaster
country: United States
facility: Center for Interventional Pain and Spine
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital Department of Neurosurgery
state: Pennsylvania
city: Charleston
country: United States
facility: The Spine & Nerve Center of St. Francis Hospital
state: West Virginia
city: Huntington
country: United States
facility: St. Mary's Hospital
state: West Virginia
Study officials:
affiliation: Abbott
name: Marie Fahey
role: STUDY_DIRECTOR
References: