Chronic intractable pain Chronic intractable pain
Conditions
Interventions
Following consent and enrollment, baseline data will be obtained. Under
monitored anesthesia care, and using standard epidural lead implantation
techniques, physicians will implant up to four (4) le
Sponsors
Spinal Modulation
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Safety as determined by adverse event reporting 2) Device performance as determined by device functioning | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Pain Relief as measured with the visual analog scale 2) Quality of Life is measured with the EQ-5D Questionnaire 3) Disability as measured with the Brief Pain Inventory (BPI) 4) Pain distribution and paresthesia mapping 5) Patient Global Impression of Change (PGIC) 6) Subject satisfaction rating 7) Pain medication utilization 8) Device programming | — |
Countries
Netherlands
Outcome results
None listed