Failed back surgery syndrome, chronic low back pain
Conditions
Interventions
Passive and active burst spinal cord neuromodulation.
Sponsors
Abbott Laboratories
Eligibility
Inclusion criteria
Inclusion criteria: Subject of either gender between 18 and 65 years of age • Al least moderate level of catastrophizing as measured with the Pain catastrophizing score (PCS) of at least 20.[23] • History consistent with FBSS of at least 6 months • Neurologic exam without marked motor deficit. • Low Back Pain or leg pain intensity should be 5 or higher measured with the 11-box NRS 0-10 • Meets all the inclusion criteria for the implantation of a neurostimulation system as typically utilized in the study center. PM: depression is not an exclusion criteria • Subject has been screened by a multi-disciplinary panel including a psychologist and deemed suitable for implantation • Subject is able and willing to comply with the follow-up schedule and protocol • Subject is able to provide written informed consent
Exclusion criteria
Exclusion criteria: Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study • Escalating or changing pain condition within the past month as evidenced by investigator examination • BMI =35 • Subject has had injection therapy or radiofrequency treatment for their low back pain within the past 3 months • Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump • Subject is unable to operate the device • Severe disc degeneration at the affected level as evidenced by >50% disc height loss on plain anteroposterior and lateral lumbar radiographs or CT/MRI. • Moderate to severe spinal stenosis due to osteophyte and/or ligamentous overgrowth as evidenced by MRI or CT in the previous 6 months • Moderate to severe endplate degenerative changes at the affected levels • Grade 1-2 spondylolisthesis • Previous Neurostimulation therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is pain catastrophizing at 6 months after treatment started as measured with the pain catastrophizing scale | — |
Secondary
| Measure | Time frame |
|---|---|
| • Pain intensity as measured with the 11-box NRS for 3 days, 3 times a day at baseline, directly after the trial and at 3 ,6 , and 12 months. • Catastrophizing as measured with the pain catastrophizing scale (PCS) at baseline, 1 and 12 months. • Attention to pain as measured with the Pain vigilance and Awareness Questionnaire (PVAQ) at baseline, and at 6, and 12 months after implantation of the system. • Fear and Depression will be assessed using HADS- NL at baseline, 6 and 12 months. • Quality of Life using the EQ-5D will be assessed at baseline and 6 and 12 months follow up • Physical function assessed using the Oswestry Disability Index (ODI) at baseline, 6 and 12 months after implantation of the system • Subject Satisfaction with treatment using the Patient Global Impression of Change (PGIC), a 7-point Likert scale at 1, 3, 6, and 12 months after implantation of the system. • The number (percentage) of subjects who achieve a reduction in the LBP intensity of =50% and 30% within each system compared to baseline. Measured at 1 week (directly after the trial of the system), at 1 month, 3, 6, and 12 months. • Pain intensity as measured with the 11-box NRS in other painful anatomy related to the back pain (e.g. Leg, buttock or foot) at baseline, and 1, 6, and 12 months after implantation of the system • Chronic pain medication use will be collected at baseline and at all follow up timepoints. This includes opioids, analgesics, anticonvulsants, muscle relaxants, nonsteroidal anti-inflammatory drugs, and psychiatric mediation. • Characterization of the pain will be assessed at baseline; at 1, 6 and 12month after implantation using the painDETECT® questionnaire (designed to differentiate neuropathic and non-neuropathic pain states). This may provide interesting data in post hoc analysis of responders and non-responders to the therapy • In order to gain more insight into the role of charge delivery, in the light of pain relief and preference, Mean Charge per Second ‘CpS’ | — |
Contacts
Public ContactMartijn Mons
Maastricht University
Outcome results
None listed