A Prospective Trial to Assess the Safety and Performance of the Spinal Modulation Neurostimulator System in the Treatment of Chronic Pai

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 35

Inclusion Criteria

1.Male or female * 18 years old
2.Subject is able and willing to comply with the follow-up schedule and protocol
3.Chronic, intractable pain in the thoracic, lumbar, and/or sacral distribution(s) for at least 6 months
4.Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain
5.Minimum baseline pain rating of 60 mm on the VAS
6.Stable pain medication dosage for at least 30 days
7.Stable neurologic function in the past 30 days as assessed by investigator examination
8.In the opinion of the investigator, the subject is psychologically appropriate for the implantation for an active implantable medical device
9.Subject is able to provide written informed consent
10.Subject speaks Dutch or English

Exclusion Criteria

1.Female subject is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control
2.Escalating or changing pain condition within the past month as evidenced by investigator examination
3.Subject is currently involved in medically related litigation
4.Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
5.Subject has had radiofrequency treatment of an intended target DRG(s) within the past 3 months
6.Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump
7.Subject is unable to operate the device
8.Subjects with indwelling devices that may pose an increased risk of infection
9.Subjects currently has an active infection
10.Subject has, in the opinion of the investigator, a medical comorbidity that contraindicates placement of an active medical device
11.Subject has participated in another clinical investigation within 30 days
12.Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
13.Subject has been diagnosed with cancer in the past 2 years
14.Imaging (MRI, CT, x-ray) findings within the last 12 months that, in the investigator*s opinion, contraindicates lead placement
15.Subject has pain only within a cervical dermatomal distribution

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) Safety as determined by adverse event reporting<br /><br>2) Device performance as determined by device functioning</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) Pain Relief as measured with the visual analog scale<br /><br>2) Quality of Life is measured with the EQ-5D Questionnaire<br /><br>3) Disability as measured with the Brief Pain Inventory (BPI)<br /><br>4) Pain distribution and paresthesia mapping<br /><br>5) Patient Global Impression of Change (PGIC)<br /><br>6) Subject satisfaction rating<br /><br>7) Pain medication utilization<br /><br>8) Device programming</p><br>

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