An Implantable Spinal Cord Stimulation Pain Management System

Pain Clinical Trial

Official title:

Stimulus Confirmatory Study - An Implantable Spinal Cord Stimulation Pain Management System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00205855
• Other study ID #: CR-S-003
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: September 26, 2012
• Start date: February 2003
• Est. completion date: March 2005

Study information

• Verified date: September 2012
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

There are many treatment options available for the management of chronic pain . Some include, but are not limited to, over-the-counter medications, Non-Steroidal Anti-Inflammatory Drugs, Physical Therapy, Transcutaneous Electrical Nerve Stimulation (TENS) and nerve blocks. Historically, the mainstay of pain treatment has been pharmacotherapy. However, pharmacotherapy has varying degrees of effectiveness and is often associated with undesirable side effects. Although many patients are successfully treated, for those who fail some of these more conservative therapies the remaining option is limited to spinal cord stimulation (SCS), proven to be an effective therapy to more than half of those failing conservative treatments . Over 50% of those who have failed these more conservative methods of pain management, can now, under the guidance of a clinician utilizing SCS, have their pain levels successfully managed. SCS is a less invasive therapy that is a reversible treatment with greater long-term benefits than more permanent, radical approaches and one that deserves greater consideration in the management of chronic, intractable pain.

Description:

This clinical trial was a confirmatory study for the Advanced Bionics totally implantable Spnial Cord Stimulation(SCS) System, the Stimulus System. This system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: Dailed back surgery syndrome, intractable low backpain and leg pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: March 2005
• Est. primary completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Diagnosed with chronic, intractable pain of the trunk and/or limbs which includes but is not limited to, unilateral or bilateral pain associated with any of the following: failed back surgery syndrome, intractable low back pain and leg pain.

2. Be an appropriate candidate for surgery.

3. Be capable of giving informed consent.

4. Be capable and willing to follow all study related procedures.

Exclusion Criteria:

1. Have an inability to operate the system either by self or care-giver.

2. Are currently participating or have participated within the past 30 days in any clinical investigation that could conflict with the requirements of this study.

3. Have any implanted electrical devices, regardless of whether active or inactive.

4. Have any active implantable device regardless of whether stimulation is ON or OFF.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Failed Back Surgery Syndrome
• Pain
• Pain, Intractable

Intervention

Device:
• Precision SCS
Advanced Bionics totally implantable Spinal Cord Stimulation (SCS) System, the Stimulus System. This system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain and leg pain.

Locations

Country	Name	City	State
United States	Yellowstone Neurological Associates	Billings	Montana
United States	Cleveland Clinic	Cleveland	Ohio
United States	Dallas Neurological Associates	Dallas	Texas
United States	River Oaks Pain Management	Houston	Texas
United States	Alabama Pain Center	Huntsville	Alabama
United States	California Pain Medicine Centers	Los Angeles	California
United States	Texas Back Institute	Plano	Texas
United States	Pacific Pain Treatment Center	San Francisco	California
United States	Northshore University Hospital	Syosset	New York

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 Visual Analog Scale (VAS) Score From Baseline to 2 Week Post Initial Fitting.	The VAS score is rated by the patient for the average pain level within the past 7 days where on a scale of 0 to 10, 0 is equal to"no pain" and 10 is equal to "worst pain imaginable." This measurement is captured at baseline and again at 2 weeks post intitial fitting. The measurement is the percent difference between the VAS at 2 weeks post intital fitting from the baseline VAS.	2 weeks post initial fitting	No