PROLONG Prospective, Multi-center, Open-label, Post-market Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Pain
- Sponsor
- Abbott Medical Devices
- Enrollment
- 118
- Locations
- 21
- Primary Endpoint
- Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 3 Months
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 ≥
- •Physician has determined that the patient's original pain is still addressable with neurostimulation.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 18 Months(From baseline to 18 months)
- Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 3 Months(From baseline to 3 months)
- Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 12 Months(From baseline to 12 months)
- Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 18 Months(From baseline to 18 months)
- Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 24 Months(From baseline to 24 months)
- Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 6 Months(From baseline to 6 months)
- Change in Pain Condition-related Medication Use From Baseline to 24 Months(From baseline to 24 months)
- Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 3 Months(From baseline to 3 months)
- Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 12 Months(From baseline to 12 months)
- Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 18 Months(From baseline to 18 months)
- Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 24 Months(From baseline to 24 months)
- Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 3 Months(From baseline to 3 months)
- Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 6 Months(From baseline to 6 months)
- Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 12 Months(From baseline to 12 months)
- Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 24 Months(From baseline to 24 months)
- Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 6 Months(From baseline to 6 months)
- Change in Pain Condition-related Medication Use From Baseline to 3 Months(From baseline to 3 months)
- Change in Pain Condition-related Medication Use From Baseline to 6 Months(From baseline to 6 months)
- Change in Pain Condition-related Medication Use From Baseline to 12 Months(From baseline to 12 months)
- Change in Pain Condition-related Medication Use From Baseline to 18 Months(From baseline to 18 months)