Evaluate St Jude Medical Prodigy Neuromodulation for FBSS or Chronic Pain of the Trunk and/or Limbs
NCT ID: NCT02143791
Last Updated: 2024-07-08
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
126 participants
INTERVENTIONAL
2014-06-30
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Burst and Tonic stimulation
Interventions
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Burst and Tonic stimulation
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Tony Van Havenbergh
Role: PRINCIPAL_INVESTIGATOR
St Augustinus, Wilrijk, Belgium
Devyani Nanduri
Role: STUDY_DIRECTOR
Abbott Medical Devices
Locations
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Metro Spinal Clinic
Caulfield, , Australia
Frankston Pain Management
Frankston, , Australia
Epworth Hospital
Richmond, , Australia
St Augustinus Ziekenhuis
Wilrijk, Antwerp, Belgium
Medizinische Einrichtungen der Universität zu Köln
Cologne, , Germany
University Hospital
Düsseldorf, , Germany
Hospital Gera
Gera, , Germany
Universitätsklinik für Stereataktische Neurochirurgie
Magdeburg, , Germany
Universitatsklinikum Tubingen
Tübingen, , Germany
St Vincents University Hospital
Dublin, , Ireland
Azienda Ospedaliera Monaldi
Napoli, , Italy
Az. Ospedaliero-Universitaria Pisana - Stabilimento Santa Chiara
Pisa, , Italy
Az. Osp.S.Giovanni Addolorata
Roma, , Italy
Medisch Spectrum Twente
Enschede, , Netherlands
St Antonius Ziekenhuis
Nieuwegein, , Netherlands
Stichting Alysis Zorggroep
Velp, , Netherlands
Hospital Virgen de Rocio
Seville, , Spain
University Hospital
Uppsala, , Sweden
Seacroft Hospital
Leeds, , United Kingdom
St Bartolomew's
London, , United Kingdom
James Cook University Hospital
Middlesbrough, , United Kingdom
Countries
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Other Identifiers
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NM-13-038-ID-SC
Identifier Type: -
Identifier Source: org_study_id
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