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

Chronic Pain Clinical Trial

Official title:

Precision Spectra™ Neurostimulator System for the Treatment of Chronic Intractable Pain of the Trunk and/or Limbs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01665040
• Other study ID #: A5004
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: December 2014

Study information

• Verified date: November 2020
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

• 18 years of age or older when written informed consent is obtained

• Subject signs informed consent

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Intractable

Intervention

Device:
• Neurostimulation device implantation
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.

Locations

Country	Name	City	State
Australia	Metro Spinal Clinic	Caulfield
Australia	Hunter Clinical Research	Melbourne
Belgium	AZ Delta	Roeselare
Spain	Clinica Universitaria de Navarra	Madrid
Spain	Hospital La Paz	Madrid
Spain	Hospital Universitario Quiron Madrid	Madrid
Spain	H. Clinico Universitario	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

Australia,  Belgium,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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