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

Abbott

Status: Completed

Conditions: Chronic Pain

Treatments: Device: Burst-capable SCS system; Device: DRG Stimulator

Study type: Interventional

Funder types: Industry

Identifiers

NCT03908476

ABT-CIP-10277

Details and patient eligibility

About

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.

Enrollment: 118 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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118 participants in 2 patient groups

Subjects using BurstDR SCS systems

Experimental group

Description:

Spinal cord stimulation with a Burst waveform.

Treatment:

Device: Burst-capable SCS system

Subjects using DRG systems

Experimental group

Description:

Dorsal root ganglion stimulation.

Treatment:

Device: DRG Stimulator