Spinal Cord Stimulation for Chronic and Intractable Back Pain

NCT00370695 | Terminated Results

• 1 other identifier: SCS-03-05
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Back Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The Primary Objective of This Study is to Evaluate Back Pain Severity at 12 Weeks Post-activation as Compared to Baseline.

  12 weeks

Study Arms (1)

Precision Spinal Cord Stimulation System

EXPERIMENTAL

Single arm Precision Spinal Cord Stimulation System.

Device: Precision Spinal Cord Stimulation System

Interventions

Precision Spinal Cord Stimulation System DEVICE

Stimulation turned on from implant throughout the Study

Precision Spinal Cord Stimulation System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Huntley Pain Specialists

San Diego, California, 92108, United States

Location

MeSH Terms

Conditions

Back Pain; Radiculopathy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Limitations and Caveats

Insufficient data collected to report results

Results Point of Contact

• Title: Director, Clinical Research Sciences
• Organization: Boston Scientific

roshini.jain@bsci.com

6619494350

Study Officials

• Roshini Jain

  Boston Scientific Neuromodulation Corporation

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2006
• First Posted: September 1, 2006
• Study Start: February 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: December 17, 2020
• Results First Posted: December 17, 2020

Record last verified: 2020-11

Locations

US (1)