Spinal Cord Stimulation for Chronic and Intractable Back Pain - Full Text View

Sponsored by:	Boston Scientific Corporation
Information provided by:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT00370695

Purpose

The purpose of this study is to evaluate the efficacy of spinal cord stimulation (SCS) using the Precision implantable neurostimulation device for chronic and intractable back pain in subjects who are not candidates for surgery or who have chosen to seek alternative therapy.

Condition	Intervention	Phase
Back Pain	Device: Precision Spinal Cord Stimulation System	Phase IV

MedlinePlus related topics: Back Pain Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Spinal Cord Stimulation for Chronic and Intractable Back Pain in Patients Who Are Not Surgical Candidates

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:

The primary objective of this study is to evaluate back pain severity at 12 weeks post-activation as compared to baseline. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Cumulative frequency of adverse events. [ Time Frame: Throughout Study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The secondary objectives of this study are to determine the long-term efficacy of this treatment and the impact of treatment on quality of life and disability measures, medication use, and costs associated with medical interventions and drug use for back [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment:	15
Study Start Date:	February 2006
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Stimulation turned on from implant throughout the Study

Detailed Description:

Management of symptoms of chronic back pain and/or lumbar radiculopathy is often difficult and inadequate. Current treatment options include pharmacological treatments, physical therapy, nerve blocks, surgical interruption of the pain pathway, or back surgery. Many patients either do not have adequate pain management with conventional treatments or are not able to tolerate the treatments due to significant side effects. Similarly, many patients are either not candidates for surgical interventions, or are unwilling to undergo such procedures. Spinal cord stimulation has proven to be an effective treatment for patients with pain following a failed back surgery, and this study will investigate spinal cord stimulation as a treatment option for the treatment of chronic back pain in patients who have never had back surgery. A successful study outcome will establish spinal cord stimulation as a less-invasive treatment option to be considered prior to surgery.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Have chronic and intractable neuropathic back pain and/or lumbar radiculopathy of moderate to severe intensity and have elected Spinal Cord Stimulation (SCS) as next line of treatment.
Be 18 years of age or older.
Be an appropriate candidate for the surgical procedures required for SCS implant.
Be willing and able to comply with all study related procedures and visits.
Be capable of reading and understanding patient information materials and giving written informed consent.

Exclusion Criteria:

Have had any back or spine surgery.
Have any evidence of neurologic instability or any anatomic problem of the spine that requires surgery.
Have any other chronic pain conditions likely to confound evaluation of study endpoints.
Are a current substance abuser (including alcohol and illicit drugs).
Have a significant psychiatric disorder.
Have a condition currently requiring or likely to require the use of MRI or diathermy.
Have an active implantable device.
Are pregnant or lactating or planning to become pregnant in the next year.
Have participated in any drug or device trial in the last 4 weeks or plan to participate in any other study during the year.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00370695

Locations

United States, California
Huntley Pain Specialists
San Diego, California, United States, 92108

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

Principal Investigator:

Michael Huntley, MD

Huntley Pain Specialists

More Information

No publications provided

Responsible Party:	Boston Scientific Corporation ( Lyn Pimentel, Clinical Project Manager )
Study ID Numbers:	SCS-03-05
Study First Received:	August 30, 2006
Last Updated:	October 10, 2008
ClinicalTrials.gov Identifier:	NCT00370695 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Boston Scientific Corporation:

Chronic back pain
Intractable neuropathic back pain
Lumbar radiculopathy
Spinal cord stimulation

Study placed in the following topic categories:

Signs and Symptoms
Radiculopathy
Neurologic Manifestations
Pain
Back Pain

Additional relevant MeSH terms:

Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations
Pain
Back Pain

ClinicalTrials.gov processed this record on May 07, 2009