Restore Claims Characterization Study

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

Official title:

Restore Claims Characterization Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00200122
• Other study ID #: 1617
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: January 20, 2009
• Start date: January 2005
• Est. completion date: August 2007

Study information

• Verified date: October 2007
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Refractory Pain Associated With Failed Back Surgery Syndrome, Epidural Fibrosis, Peripheral Causalgia, Complex Regional Pain Syndrome
• Complex Regional Pain Syndromes
• Failed Back Surgery Syndrome
• Pain, Intractable
• Reflex Sympathetic Dystrophy

Intervention

Device:
• Spinal Cord Stimulation

Locations

Country	Name	City	State
United States	Contact Medtronic for Exact Location	Chicago	Illinois
United States	Contact Medtronic for Exact Location	Dallas	Texas
United States	Contact Medtronic for Exact Location	Eugene	Oregon
United States	Contact Medtronic for Exact Location	Huntington	West Virginia
United States	Contact Medtronic for Exact Location	Indianapolis	Indiana
United States	Contact Medtronic for Exact Location	Kansas City	Missouri
United States	Contact Medtronic for Exact Location	San Antonio	Texas
United States	Contact Medtronic for Exact Location	Syosset	New York

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is to assesses the pain coverage capability of the RESTORE SCS system.
Secondary	Secondary outcome measures include pain relief, quality of life, function, patient and physician acceptance.