A Prospective, , Post-Marketing Study of the Clinical Outcomes of Wireless Neuromodulation via the Freedom Spinal Cord Stimulation (SCS) System for the Management of Chronic Back and Leg Pai

Completed

Conditions: chronic back and leg pain
Failed back surgery syndrome
10009720

Registration Number: NL-OMON42568

Lead Sponsor: Clinical affairs

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

• Appropriate Freedom SCS candidate as affirmed by study investigator
• Candidate has a stable spine not suitable for further surgery as confirmed by physician
• 18 years of age or older (no upper age limit)
• Diagnosis of failed back surgery syndrome (FBSS) characterized by chronic, intractable pain of the legs, back, or both legs and back
• At least 6 months since last surgical procedure on the spine
• Average score of 60mm or greater on a VAS scale (Scale of 0 to 100, where 0 equals no pain and 100 equals worst possible pain)
• Pain duration of at least 6 months
• Expected lifespan of at least two years
• Able to comply with study requirements
• Gives informed consent for study participation

Exclusion Criteria

• A consistent VAS score of 100 over the past 24 hours as established at Visit 1
• A co-existing condition that could increase the risk of SCS implantation (e.g., severe cardiac or respiratory disorders, coagulation disorder) or planned surgery within the study duration that could be compromised by SCS (e.g., diathermy)
• Pregnant or planning to become pregnant
• Known or suspected substance abuse within the last 2 years
• Major psychiatric disorder (untreated or refractory to treatment) in the investigators opinion
• Cognitive and/or behavioral issues that could impair study participation, (e.g., unreliability; defective memory; noncompliance in taking medications or keeping appointments; or impaired orientation to time, place, and events)
• Documented allergy to Freedom SCS material components
• Co-existing pain condition or participation in another clinical study that could confound the results of this study
• History of another implanted medical device (e.g., explanted spinal cord stimulator, peripheral nerve stimulation, sacral nerve stimulator, pacemaker, or intrathecal drug delivery)

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcomes<br /><br>1. Percentage of pain relief experienced in the area of pain identified at<br /><br>baseline compared to 12 months post full implant of the Freedom SCS system.<br /><br><br /><br>2. Incidence and severity of device related adverse events during the study,<br /><br>for example:<br /><br>a. Biological response to the implant procedure requiring treatment (e.g.,<br /><br>hematoma, dural puncture, skin erosion or infection, allergic reaction)<br /><br>b. Technical failure of the electrode (e.g., electrode failure, fracture, or<br /><br>migration/malposition requiring removal/replacement)<br /><br>c. Technical failure of the external pulse generator (e.g., power level<br /><br>variations, over/under/intermittent /uncomfortable stimulation, unacceptable<br /><br>postural effects, device interaction with external stimulus). (Note:<br /><br>programming changes to increase paresthesia coverage to capture areas of new<br /><br>pain are not adverse events.)</p><br>

Secondary Outcome Measures