High Rate Spinal Cord Stimulation (SCS) for Chronic Pain

NCT01624740 | Completed Results

• 1 other identifier: A7001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• 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).

Study Arms (2)

Low Rate Followed By High Rate

EXPERIMENTAL

The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects received low rate stimulation (2 Hz) for 3-4 days, followed by high rate stimulation (1200 Hz) for 3-4 days.

Device: Low Rate Stimulation; Device: High Rate Stimulation

High Rate Followed By Low Rate

EXPERIMENTAL

The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects received high rate stimulation (1200 Hz) for 3-4 days, followed by low rate stimulation (2 Hz) for 3-4 days.

Device: Low Rate Stimulation; Device: High Rate Stimulation

Interventions

Low Rate Stimulation DEVICE

Stimulation was given at a rate of 2 Hz.

High Rate Followed By Low Rate; Low Rate Followed By High Rate

High Rate Stimulation DEVICE

Stimulation was given at a rate of 1200 Hz.

High Rate Followed By Low Rate; Low Rate Followed By High Rate

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
• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Coastal Pain Spinal Diagnostic

Carlsbad, California, 92009, 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: Nitzan Mekel-Bobrov, PhD
• Organization: Boston Scientific

Nitzan.Mekel-Bobrov@bsci.com

661-949-4537

Study Officials

• Omid Khodai, OD

  Boston Scientific Corporation

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2012
• First Posted: June 21, 2012
• Study Start: June 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 20, 2015
• Results First Posted: March 20, 2015

Record last verified: 2014-12

Locations

US (1)