Spinal Cord Stimulation Research Study

NCT ID: NCT00737581

Last Updated: 2017-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-04-30

Brief Summary

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The purpose of this study is to characterize subjects' response to spinal cord stimulation with postural changes.

Detailed Description

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Conditions

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Chronic Low Back and Leg Pain

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Be ambulatory
* Be 18 years of age or older
* Have chronic low back pain and/or leg pain due to neuropathic causes
* Be implanted with the Restore or Restore Advanced system for greater than or equal to 3 months
* Be implanted with percutaneous thoracic leads
* Have stable pain control
* Adjust stimulation parameters manually on a regular basis
* Be willing and able to complete protocol requirements
* Be willing and able to provide written informed consent
* Be male or nonpregnant female

Exclusion Criteria

* Plan to enroll in another clinical study during participation in this study, or currently enrolled in another clinical study
* Be morbidly obese
* Had pain-related surgery in the previous 12 weeks of enrollment or intend to undergo surgery during the period of the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MedtronicNeuro

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David M Schultz, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Advanced Pain Specialists

Cristy Schade, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Pain Control

Locations

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Medical Advanced Pain Specialists (MAPS)

Edina, Minnesota, United States

Site Status

Center for Pain Control

Garland, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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1648

Identifier Type: -

Identifier Source: org_study_id

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