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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

100

participants targeted

Target at P50-P75 for phase_4

Timeline

Completed

Started Jan 2005

Typical duration for phase_4

Geographic Reach

1 country

8 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.6 years study duration

Study Start

First participant enrolled

January 1, 2005

Completed

8 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed

8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed

1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed

Last Updated

January 21, 2009

Status Verified

October 1, 2007

First QC Date

September 12, 2005

Last Update Submit

January 20, 2009

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

Spinal Cord StimulationDEVICE

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

Requires, or will in the future, diathermy treatments.
Had implanted spinal cord stimulation system within the last six months.

Contact the study team to confirm eligibility.