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

NCT ID: NCT03908476

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-16
• Study Completion Date: 2021-11-15

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Subjects using BurstDR SCS systems

Spinal cord stimulation with a Burst waveform.

Group Type: EXPERIMENTAL

Burst-capable SCS system

Intervention Type: DEVICE

Subjects will be given Burst stimulation using a market-released Abbott SCS system. Burst stimulation may be achieved through surgical or non-surgical means.

Subjects using DRG systems

Dorsal root ganglion stimulation.

Group Type: EXPERIMENTAL

DRG Stimulator

Intervention Type: DEVICE

Subjects will be implanted with a market-released Abbott DRG stimulation system.

Interventions

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.

Intervention Type: DEVICE

DRG Stimulator

Subjects will be implanted with a market-released Abbott DRG stimulation system.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie Fahey

Role: STUDY_DIRECTOR

Abbott

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ABT-CIP-10277

Identifier Type: -

Identifier Source: org_study_id