Clinical Outcomes Study Using a New Implantable Neurostimulation System for Chronic Intractable Pain

NCT01665040 | Completed Results

• 1 other identifier: A5004
• Study Type: interventional
• Target: 40
• Locations: 3 countries
• Sites: 7

Brief Summary

The primary objective of this study is to investigate patient satisfaction with treatment using a new implantable neurostimulation system for chronic pain of the trunk and/or limbs.

Conditions

Chronic Pain

Keywords

neurostimulation; spinal cord stimulation; peripheral nerve stimulation

Outcome Measures

Primary Outcomes (2)

• Proportion of Subjects Satisfied With Treatment at 90 Days Post-IPG Implantation

  Proportion of subjects satisfied with treatment at 90 days post-IPG implantation, as measured by a 7-point Patient Satisfaction with Treatment (PSWT) questionnaire.

  90-days post permanent implantation

• Proportion of Subjects Satisfied With Treatment in a Sub-group Utilizing More Than 2 IPG Ports at 365 Days Post-IPG Implantation

  Proportion of subjects in a sub-group utilizing more than 2 IPG ports at 365 Days post-IPG implantation satisfied with treatment, as measured by a 7-point Patient Satisfaction with Treatment (PSWT) questionnaire.

  365 days post permanent implantation

Study Arms (1)

Neurostimulation for chronic pain

EXPERIMENTAL

Neurostimulation (spinal cord stimulation with or without peripheral nerve stimulation of the trunk) for chronic intractable pain of the trunk and/or limbs.

Device: Neurostimulation device implantation

Interventions

Neurostimulation device implantation DEVICE

Study subjects will undergo a screening-trial of neurostimulation using the Boston Scientific Corporation Precision Spectra neurostimulation system and may proceed to permanent implantation in the event of a successful screening trial. Treatment will include spinal cord stimulation and may also include peripheral nerve stimulation, based upon the physician's subject-specific treatment plan.

Neurostimulation for chronic pain

Eligibility Criteria

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

You may qualify if:

• Chronic intractable pain of the trunk and/or limbs
• Documented history of trunk and/or limb pain of at least 180 days
• Overall pain intensity of at least 5 on a 0-10 numerical rating scale (OPI-NRS-11) over the past 180 days based on subject recall
• Pass study site's routine psychological/psychiatric evaluation within 180 days before signing the informed consent
• Subject is willing and able to comply with all protocol-required follow-up evaluations
• years of age or older when written informed consent is obtained
• Subject signs informed consent

You may not qualify if:

• Unable to operate the Precision Spectra™ System either by self or with a caregiver
• Primary source of pain is cancer-related, pelvic, visceral, anginal or migraine
• Overall pain intensity of always 10 on a 0-10 numerical rating scale (OPI-NRS-11) over the past 180 days based on subject recall
• Is a high surgical risk
• Currently on any anticoagulant medications that cannot be discontinued during perioperative period
• Subject requires Magnetic Resonance Imaging (MRI) while implanted with lead(s) and/or the Precision Spectra IPG
• Subject is participating (or intends to participate) in another investigational drug or device clinical trial that may influence the data that will be collected for this study
• Subjects already implanted with an active implantable device(s) to treat their pain (IPGs, implantable drug pumps, etc) or pacemaker or Implantable Cardiac Defibrillator
• Patient is a woman who is pregnant (a urine pregnancy test must be performed within 7 days prior to the stimulation trial procedure in women of child-bearing potential) or nursing or intends to become pregnant during the course of the trial.
• Failed to achieve satisfactory relief during the stimulation trial phase

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (7)

Metro Spinal Clinic

Caulfield, Australia

Location

Hunter Clinical Research

Melbourne, Australia

Location

AZ Delta

Roeselare, Belgium

Location

Clinica Universitaria de Navarra

Madrid, Spain

Location

Hospital La Paz

Madrid, Spain

Location

Hospital Universitario Quiron Madrid

Madrid, Spain

Location

H. Clinico Universitario

Valencia, Spain

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: Roshini Jain, Director of Clinical Sciences
• Organization: Boston Scientific

rjain@bsci.com

6619494350

Study Officials

• Roshini Jain

  Boston Scientific Neuromodulation Corporation

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2012
• First Posted: August 15, 2012
• Study Start: August 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 19, 2020
• Results First Posted: January 3, 2019

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); ES (4); AU (2)