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Spinal Cord Stimulation for Chronic and Intractable Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00370695
Recruitment Status : Terminated (Insufficient Data Collected)
First Posted : September 1, 2006
Last Update Posted : August 5, 2013
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
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 or disease Intervention/treatment Phase
Back Pain Device: Precision Spinal Cord Stimulation System Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Spinal Cord Stimulation for Chronic and Intractable Back Pain in Patients Who Are Not Surgical Candidates
Study Start Date : February 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Active Comparator: Precision Spinal Cord Stimulation System
Single arm Precision Spinal Cord Stimulation System.
Device: Precision Spinal Cord Stimulation System
Stimulation turned on from implant throughout the Study

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Cumulative frequency of adverse events [ Time Frame: Throughout study ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00370695

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United States, California
Huntley Pain Specialists
San Diego, California, United States, 92108
Sponsors and Collaborators
Boston Scientific Corporation
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Principal Investigator: Michael Huntley, MD Huntley Pain Specialists
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Responsible Party: Boston Scientific Corporation Identifier: NCT00370695    
Other Study ID Numbers: SCS-03-05
First Posted: September 1, 2006    Key Record Dates
Last Update Posted: August 5, 2013
Last Verified: August 2013
Keywords provided by Boston Scientific Corporation:
Chronic back pain
Intractable neuropathic back pain
Lumbar radiculopathy
Spinal cord stimulation
Additional relevant MeSH terms:
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Back Pain
Neurologic Manifestations