Spinal Cord Stimulation Research Study | NCT00768872

Studies
Spinal Cord Stimulation Research Study

NCT00768872

Sponsor

MedtronicNeuro

Status

Completed

Last Update Posted

Oct 14, 2016Estimated

Enrollment

66Actual

Phase

Not provided

Conditions

Chronic Low Back and Leg Pain

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Mar 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Oct 7, 2008

First Submission Date that Met QC Criteria

Oct 7, 2008

First Posted Date

Oct 8, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 13, 2016

Last Update Posted Date

Oct 14, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

66Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from Baseline in Physical Activity (total centi-Gs per 5.125 seconds)		4, 12, 24 weeks post implant
Change from Baseline in Posture Parameters (minutes per 24 hours)		4, 12, 24 weeks post implant

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years of age or older
Candidate for SCS device trial
Subject is ambulatory
Diagnosed with low back pain or low back pain plus leg pain for at least 6 months
Undergoing treatment for low back pain or low back pain plus leg pain
Does not have or has not had a previous SCS implant
Willing and able to complete protocol requirements
Willing and able to sign the study-specific Informed Consent form
Male or non-pregnant female

Exclusion Criteria:

Have plans to enroll in another clinical study during their participation in this study, or are currently enrolled in a clinical study that could interfere in participation in the trial or affect the scientific soundness of this study
Cancer or any other malignant disease
Present or past diagnosis of schizophrenia or of delusional, psychotic, or dissociative disorder
A pain-related surgery in the previous 12 weeks of enrollment, the intent to undergo surgery during the period of the study
Non-English speaking or an inability to complete questionnaires accurately

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Candidates for Spinal Cord Stimulation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David M Schultz, MD	Medical Advanced Pain Specialists (MAPS)	Principal Investigator
Robert Jamison, Ph.D	Brigham and Women's Hospital	Principal Investigator
Eric Grigsby, M.D.	Napa Pain Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Napa Pain Institute		Napa	California	94558	United States
Brigham and Women's Hospital

Condition Browse Module

MeSH Terms

ID	Term
D009043	Motor Activity
D010146	Pain

Ancestor Terms

ID	Term
D001519	Behavior
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided