A Post-market Study Evaluating the Prodigy Neuromodulation System for the Management of Failed Back Surgery Syndrome or Chronic Intractable Pain of the Trunk and/or Limbs.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Medical Devices
- Enrollment
- 126
- Locations
- 21
- Primary Endpoint
- Percentage Change From Baseline in Overall VAS at 3 Months
Study Overview
Brief Summary
The purpose of this study is to confirm long term efficacy and safety of the ProdigyTM neuromodulation system in the management of failed back surgery syndrome or chronic intractable pain of the trunk and/or limbs.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient with chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome or intractable low back and/or leg pain
- •Patient diagnosed with radiculopathy
- •Patient diagnosed with neuropathic pain
- •Patient is considered by the investigator as a candidate for implantation of a SCS system
- •Patient is ≥ 18 years of age
- •Patient must be willing and able to comply with study requirements
- •Patient must indicate his/her understanding of the study and willingness to participate by signing an appropriate Informed Consent Form
Exclusion Criteria
- •Patient is diagnosed with ischemic pain
- •Patient is diagnosed with arachnoiditis
- •Patient is diagnosed with complex regional pain syndrome (CRPS I and II)
- •Patient is diagnosed with peripheral vascular disease (PVD)
- •Patient is diagnosed with diabetic neuropathic pain
- •Patient is diagnosed with chronic migraine
- •Patient is immune-compromised
- •Patient has history of cancer requiring active treatment in the last 6 months
- •Patient has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the last 6 months
- •Patients with a SCS system or implantable infusion pump implanted previously
- •Patient has a life expectancy of less than one year
- •Patient is pregnant or is planning to become pregnant during the duration of the investigation
- •Patient is unable to comply with the follow up schedule
- •Patient needing legally authorized representative
- •Patient unable to read and write
- •Patient is currently participating in another clinical investigation with an active treatment arm.
Arms & Interventions
Burst and Tonic stimulation
All subjects were required to receive BurstDR stimulation therapy for the first 3 months after permanent implant. Thereafter the stimulation mode could be changed to tonic stimulation depending on patient's preference or physician's discretion.
Intervention: Burst and Tonic stimulation (Procedure)
Outcomes
Primary Outcomes
Percentage Change From Baseline in Overall VAS at 3 Months
Time Frame: 3 months
Percentage change in pain relief at the 3- month follow-up visit compared to baseline visit, as measured by the Visual Analog Scale (VAS). The VAS scale with a 10 cm (or 100 mm) line to indicate pain intensity progression with no pain (0) on the left end and worst pain (100) on the right end. Percent change is calculated as "\[(post baseline baseline)/baseline\] \*100%" with positive numbers to represent increases and negative numbers to represent decreases.
Secondary Outcomes
- Change in Pain Catastrophizing Scale(12 Months)
- Rate of Serious Adverse Events and/or Procedure/Device-related Adverse Events(from enrollment to 12 months follow up)
- Pain Relief(12 Months)
- Number of Participants With Analgesic Reduction(12 Months)
- Change in Quality of Life(Baseline and 12 Months)
- Paresthesia Mapping at 3 Months Compared to the Empower Study(3 Months)
- Pain Relief(3 Months)
- Pain Relief(6 Months)