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Restore Claims Characterization Study

Primary Purpose

Chronic Refractory Pain Associated With Failed Back Surgery Syndrome, Epidural Fibrosis, Peripheral Causalgia, Complex Regional Pain Syndrome

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Spinal Cord Stimulation
Sponsored by
MedtronicNeuro
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Refractory Pain Associated With Failed Back Surgery Syndrome, Epidural Fibrosis, Peripheral Causalgia, Complex Regional Pain Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Has chronic refractory pain associated with one of the conditions currently approved for spinal cord stimulation as follows: Failed Back Syndrome, Degenerative Disk Disease (DDD), Herniated Disk pain refractory to conservative and surgical interventions, Peripheral Causalgia, Complex Regional Pain Syndrome (CRPS) or Reflex Sympathetic Dystrophy (RSD). Primary pain in the lower half of the body. Exclusion Criteria: Requires, or will in the future, diathermy treatments. Had implanted spinal cord stimulation system within the last six months.

Sites / Locations

  • Contact Medtronic for Exact Location
  • Contact Medtronic for Exact Location
  • Contact Medtronic for Exact Location
  • Contact Medtronic for Exact Location
  • Contact Medtronic for Exact Location
  • Contact Medtronic for Exact Location
  • Contact Medtronic for Exact Location
  • Contact Medtronic for Exact Location

Outcomes

Primary Outcome Measures

The primary endpoint is to assesses the pain coverage capability of the RESTORE SCS system.

Secondary Outcome Measures

Secondary outcome measures include pain relief, quality of life, function, patient and physician acceptance.

Full Information

First Posted
September 12, 2005
Last Updated
January 20, 2009
Sponsor
MedtronicNeuro
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1. Study Identification

Unique Protocol Identification Number
NCT00200122
Brief Title
Restore Claims Characterization Study
Official Title
Restore Claims Characterization Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
MedtronicNeuro

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to characterize the pain coverage capability of the RESTORE spinal cord stimulation (SCS) and assess health outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Refractory Pain Associated With Failed Back Surgery Syndrome, Epidural Fibrosis, Peripheral Causalgia, Complex Regional Pain Syndrome

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Spinal Cord Stimulation
Primary Outcome Measure Information:
Title
The primary endpoint is to assesses the pain coverage capability of the RESTORE SCS system.
Secondary Outcome Measure Information:
Title
Secondary outcome measures include pain relief, quality of life, function, patient and physician acceptance.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has chronic refractory pain associated with one of the conditions currently approved for spinal cord stimulation as follows: Failed Back Syndrome, Degenerative Disk Disease (DDD), Herniated Disk pain refractory to conservative and surgical interventions, Peripheral Causalgia, Complex Regional Pain Syndrome (CRPS) or Reflex Sympathetic Dystrophy (RSD). Primary pain in the lower half of the body. Exclusion Criteria: Requires, or will in the future, diathermy treatments. Had implanted spinal cord stimulation system within the last six months.
Facility Information:
Facility Name
Contact Medtronic for Exact Location
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Contact Medtronic for Exact Location
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Contact Medtronic for Exact Location
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Contact Medtronic for Exact Location
City
Syosset
State/Province
New York
Country
United States
Facility Name
Contact Medtronic for Exact Location
City
Eugene
State/Province
Oregon
Country
United States
Facility Name
Contact Medtronic for Exact Location
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Contact Medtronic for Exact Location
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Contact Medtronic for Exact Location
City
Huntington
State/Province
West Virginia
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34854473
Citation
O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.
Results Reference
derived

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Restore Claims Characterization Study

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