High Rate Spinal Cord Stimulation (SCS) for Chronic Pain

Chronic Pain Clinical Trial

Official title:

Precision Plus™ High-Rate Subperception SCS for the Treatment of Chronic Intractable Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01624740
• Other study ID #: A7001
• Status: Completed
• Phase: N/A
• First received: June 15, 2012
• Last updated: March 9, 2015
• Start date: June 2012
• Est. completion date: December 2013

Study information

• Verified date: December 2014
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To determine the effects of varying spinal cord stimulation programming parameters, including stimulation rate, on pain intensity.

Description:

This study compared the effects of high-rate subperception stimulation with the effects of low-rate subperception stimulation on pain intensity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• 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

• Average back pain intensity of 5 or greater on a 0-10 numerical rating scale during the 7-day period prior to the Screening Visit

• Pass study site's routine psychological/psychiatric evaluation within 180 days of the Trial Lead Insertion Visit

• If taking any medications for chronic pain, must be on a stable prescription during the 14-day period prior to the Trial Lead Insertion Visit and agree to continue on the same prescription throughout study participation

• Subject is willing and able to comply with all protocol-required procedures and assessments/evaluations

• Subject is able to independently read and complete all questionnaires and/or assessments provided in English

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

• Subject signs a valid, Institutional Review Board (IRB)-approved informed consent form (ICF) provided in English

Exclusion Criteria:

• Unable to operate the Precision Plus system

• Primary source of pain is cancer-related, pelvic, visceral, angina, or migraine

• Is a high surgical risk

• Is diabetic

• Is immunocompromised

• Currently on any anticoagulant medications that cannot be discontinued during perioperative period

• Untreated major depression or untreated generalized anxiety disorder

• Diagnosed with somatoform disorder, severe personality disorder, borderline personality disorder

• Diagnosed with any major psychiatric disorder not specifically listed in CE7 or CE8

• Currently diagnosed with cognitive impairment that would limit subject's ability to discern differences in pain severity, complete a pain diary, perform wound care

• Current abuse of alcohol or illicit drugs

• Subject requires Magnetic Resonance Imaging (MRI) while implanted with lead(s).

• Subject is participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study

• Subject has previously undergone a spinal cord stimulation trial or is already implanted with an active implantable device(s) to treat their pain (Implantable Pulse Generators (IPGs), implantable drug pump, etc.) or pacemaker or implantable cardiac defibrillator

• Patient is a woman who is not using adequate contraception, is pregnant or breastfeeding or intends to become pregnant during the course of the study (a urine pregnancy test must be performed within 28 days prior to the Trial Lead Insertion Visit in women of child-bearing potential and the test result documented)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Device:
• Low Rate Stimulation
Stimulation was given at a rate of 2 Hz.
• High Rate Stimulation
Stimulation was given at a rate of 1200 Hz.

Locations

Country	Name	City	State
United States	Coastal Pain Spinal Diagnostic	Carlsbad	California

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Back Pain Intensity	Back pain intensity was measured on a 0-10 numerical rating scale (0="no pain", 10="worst pain imaginable") at baseline and following low rate and high rate stimulation. This outcome measure compared the change in intensity from baseline between low rate and high rate stimulation.	For this measure, outcome was assessed at baseline, the end of the first intervention (3 or 4 days post-implantation, depending on the subject), and the end of the second intervention (6 or 8 days post-implantation, depending on the subject).	No