The primary objective of this study is to investigate patient satisfaction with treatment using a new implantable neurostimulation system for chronic pain of the trunk and/or limbs.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Study subjects will undergo a screening-trial of neurostimulation using the Boston Scientific Corporation Precision Spectra neurostimulation system and may proceed to permanent implantation in the event of a successful screening trial. Treatment will include spinal cord stimulation and may also include peripheral nerve stimulation, based upon the physician's subject-specific treatment plan.
Metro Spinal Clinic
Caulfield, Australia
Hunter Clinical Research
Melbourne, Australia
AZ Delta
Roeselare, Belgium
Clinica Universitaria de Navarra
Madrid, Spain
Proportion of Subjects Satisfied With Treatment at 90 Days Post-IPG Implantation
Proportion of subjects satisfied with treatment at 90 days post-IPG implantation, as measured by a 7-point Patient Satisfaction with Treatment (PSWT) questionnaire.
Time frame: 90-days post permanent implantation
Proportion of Subjects Satisfied With Treatment in a Sub-group Utilizing More Than 2 IPG Ports at 365 Days Post-IPG Implantation
Proportion of subjects in a sub-group utilizing more than 2 IPG ports at 365 Days post-IPG implantation satisfied with treatment, as measured by a 7-point Patient Satisfaction with Treatment (PSWT) questionnaire.
Time frame: 365 days post permanent implantation
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Hospital La Paz
Madrid, Spain
Hospital Universitario Quiron Madrid
Madrid, Spain
H. Clinico Universitario
Valencia, Spain