Clinical trial NCT02143791: Evaluate St Jude Medical Prodigy Neuromodulation for FBSS or Chronic Pain of the Trunk and/or Limbs
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: SCS
Burst stimulation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2014-05-21
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage Change From Baseline in Overall VAS at 3 Months
timeFrame: 3 months
Secondary outcomes:
measure: Pain Relief
timeFrame: 3 Months
measure: Pain Relief
timeFrame: 6 Months
measure: Pain Relief
timeFrame: 12 Months
measure: Change in Pain Catastrophizing Scale
timeFrame: 12 Months
measure: Number of Participants With Analgesic Reduction
timeFrame: 12 Months
measure: Change in Quality of Life
timeFrame: Baseline and 12 Months
measure: Rate of Serious Adverse Events and/or Procedure/Device-related Adverse Events
timeFrame: from enrollment to 12 months follow up
measure: Paresthesia Mapping at 3 Months Compared to the Empower Study
timeFrame: 3 Months
Other outcomes:
Locations:
city: Caulfield
country: Australia
facility: Metro Spinal Clinic
city: Frankston
country: Australia
facility: Frankston Pain Management
city: Richmond
country: Australia
facility: Epworth Hospital
city: Wilrijk
country: Belgium
facility: St Augustinus Ziekenhuis
state: Antwerp
city: Duesseldorf
country: Germany
facility: University Hospital
city: Gera
country: Germany
facility: Hospital Gera
city: Köln
country: Germany
facility: Medizinische Einrichtungen der Universität zu Köln
city: Magdeburg
country: Germany
facility: Universitätsklinik für Stereataktische Neurochirurgie
city: Tubingen
country: Germany
facility: Universitatsklinikum Tubingen
city: Dublin
country: Ireland
facility: St Vincents University Hospital
city: Napoli
country: Italy
facility: Azienda Ospedaliera Monaldi
city: Pisa
country: Italy
facility: Az. Ospedaliero-Universitaria Pisana - Stabilimento Santa Chiara
city: Roma
country: Italy
facility: Az. Osp.S.Giovanni Addolorata
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Nieuwegein
country: Netherlands
facility: St Antonius Ziekenhuis
city: Velp
country: Netherlands
facility: Stichting Alysis Zorggroep
city: Sevilla
country: Spain
facility: Hospital Virgen de Rocio
city: Uppsala
country: Sweden
facility: University Hospital
city: Leeds
country: United Kingdom
facility: Seacroft Hospital
city: London
country: United Kingdom
facility: St Bartolomew's
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
Study officials:
affiliation: St Augustinus, Wilrijk, Belgium
name: Tony Van Havenbergh
role: PRINCIPAL_INVESTIGATOR
affiliation: Abbott Medical Devices
name: Devyani Nanduri
role: STUDY_DIRECTOR
References: