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

Completed · Not applicable

Conditions studied: Chronic Pain

In brief

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.

Key facts

Study ID: NCT03908476
Run by: Abbott Medical Devices
People needed: 118
Starts: 2019-04-16
Expected to finish: 2021-11-15
Last updated by the study team: 2023-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Spanish Hills Interventional Pain Specialists — Camarillo, California, United States
Coastal Pain & Spinal Diagnostics Medical Group — Carlsbad, California, United States
UC San Diego Center for Pain Medicine — La Jolla, California, United States
Napa Valley Orthopedic Medical Group — Napa, California, United States
Newport Beach Headache & Pain — Newport Beach, California, United States
Spine & Nerve Diagnostic Center — Roseville, California, United States
Pacific Research Institute — San Francisco, California, United States
Front Range Pain Medicine — Fort Collins, Colorado, United States
Boca Raton Regional Hospital — Boca Raton, Florida, United States
Pain Care, LLC — Stockbridge, Georgia, United States
Brigham & Women's Hospital — Boston, Massachusetts, United States
Nura — Edina, Minnesota, United States
Nevada Advanced Pain Specialists — Reno, Nevada, United States
Garden State Pain Control — Clifton, New Jersey, United States
Albany Medical College at Albany Medical Center — Albany, New York, United States
Ainsworth Institute of Pain Management — New York, New York, United States
Northwest Brain & Spine — Bend, Oregon, United States
Center for Interventional Pain and Spine — Lancaster, Pennsylvania, United States
Allegheny General Hospital Department of Neurosurgery — Pittsburgh, Pennsylvania, United States
The Spine & Nerve Center of St. Francis Hospital — Charleston, West Virginia, United States
St. Mary's Hospital — Huntington, West Virginia, United States

Full record on ClinicalTrials.gov

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