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

NCT03908476 | Completed Results FDA Device

• 1 other identifier: ABT-CIP-10277
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 21

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

Keywords

Chronic Pain; Spinal cord stimulation; ABT-CIP-10277; BurstDR; SCS; DRG

Outcome Measures

Primary Outcomes (5)

• Mean Change in Pain Assessed by Numerical Rating Scale (NRS) 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.

  From Baseline to 3 months

• Mean Change in Pain Assessed by Numerical Rating Scale (NRS) 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.

  From Baseline to 6 months

• Mean Change in Pain Assessed by Numerical Rating Scale (NRS) 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.

  From Baseline to 12 months

• Mean Change in Pain Assessed by Numerical Rating Scale (NRS) 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.

  From Baseline to 18 months

• Mean Change in Pain Assessed by Numerical Rating Scale (NRS) 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.

  From Baseline to 24 months

Secondary Outcomes (20)

• 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 6 Months

  From baseline to 6 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

Study Arms (2)

Subjects using BurstDR SCS systems

EXPERIMENTAL

Spinal cord stimulation with a Burst waveform.

Device: Burst-capable SCS system

Subjects using DRG systems

EXPERIMENTAL

Dorsal root ganglion stimulation.

Device: DRG Stimulator

Interventions

Burst-capable SCS system 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 BurstDR SCS systems

DRG Stimulator DEVICE

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

Subjects using DRG systems

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (21)

Spanish Hills Interventional Pain Specialists

Camarillo, California, 93010, United States

Location

Coastal Pain & Spinal Diagnostics Medical Group

Carlsbad, California, 92009, United States

Location

UC San Diego Center for Pain Medicine

La Jolla, California, 92037, United States

Location

Napa Valley Orthopedic Medical Group

Napa, California, 94558, United States

Location

Newport Beach Headache & Pain

Newport Beach, California, 92660, United States

Location

Spine & Nerve Diagnostic Center

Roseville, California, 95661, United States

Location

Pacific Research Institute

San Francisco, California, 94104, United States

Location

Front Range Pain Medicine

Fort Collins, Colorado, 80528, United States

Location

Boca Raton Regional Hospital

Boca Raton, Florida, 33486, United States

Location

Pain Care, LLC

Stockbridge, Georgia, 30281, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Nura

Edina, Minnesota, 55435, United States

Location

Nevada Advanced Pain Specialists

Reno, Nevada, 89511, United States

Location

Garden State Pain Control

Clifton, New Jersey, 07013, United States

Location

Albany Medical College at Albany Medical Center

Albany, New York, 12208, United States

Location

Ainsworth Institute of Pain Management

New York, New York, 10022, United States

Location

Northwest Brain & Spine

Bend, Oregon, 97701, United States

Location

Center for Interventional Pain and Spine

Lancaster, Pennsylvania, 17604, United States

Location

Allegheny General Hospital Department of Neurosurgery

Pittsburgh, Pennsylvania, 15212, United States

Location

The Spine & Nerve Center of St. Francis Hospital

Charleston, West Virginia, 25301, United States

Location

St. Mary's Hospital

Huntington, West Virginia, 25702, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Marie Fahey
• Organization: Abbott

Marie.fahey@abbott.com

+15122864398

Study Officials

• Marie Fahey

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: April 9, 2019
• Study Start: April 16, 2019
• Primary Completion: November 15, 2021
• Study Completion: November 15, 2021
• Last Updated: August 1, 2023
• Results First Posted: January 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (21)