Chronic intractable pain Chronic intractable pain
Conditions
Interventions
None listed
Sponsors
Spinal Modulation NV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1.Subject is at least 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 in the primary region of pain 6.In the opinion of the investigator, the subject is psychologically appropriate for the implantation for an active implantable medical device 7.Subject is able to provide written informed consent 8.Subject speaks Dutch or English
Exclusion criteria
Exclusion criteria: 1.Female subject of childbearing potential 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 has had corticosteroid therapy at an intended site of stimulation within the past 30 days 4.Subject has had radiofrequency treatment of an intended target DRG(s) within the past 3 months 5.Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump 6.Subject has pain only or primarily within a cervical dermatomal distribution 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pain relief measured using a Visual Analogue Scale (VAS). 2. Device safety by monitoring occurrence of (S)AEs 3. Quality of life (EQ-5D) 4. Physical functioning (BPI, ODI) 5. Oswestry low back pain disability questionairy 6. Pain distribution 7. Paresthesia distribution 8.Subject satisfaction | — |
Countries
Netherlands
Outcome results
None listed