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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
126
Metro Spinal Clinic
Caulfield, Australia
Frankston Pain Management
Frankston, Australia
Percentage Change From Baseline in Overall VAS at 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.
Time frame: 3 months
Pain Relief
Patient reported pain relief. Patients were asked to evaluate their pain relief over the past week in percentage with 0% being no pain relief and 100% being complete pain relief.
Time frame: 3 Months
Pain Relief
Patient reported pain relief. Patients were asked to evaluate their pain relief over the past week in percentage with 0% being no pain relief and 100% being complete pain relief.
Time frame: 6 Months
Pain Relief
Patient reported pain relief. Patients were asked to evaluate their pain relief over the past week in percentage with 0% being no pain and 100% being complete pain relief.
Time frame: 12 Months
Change in Pain Catastrophizing Scale
The pain catastrophizing scale (PCS) is a validated scale containing 13 items to assess thoughts and feelings about pain while a person is experiencing pain. The total of all 13 items results in a minimum of 0 and a maximum of 54; scores above 30 indicate clinically significant pain catastrophizing. The mean change was calculated based on the value at 12 months minus the value at baseline.
Time frame: 12 Months
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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
...and 11 more locations
Number of Participants With Analgesic Reduction
Patient reported analgesic usage during the 4 weeks preceding the 12-month follow-up visit, compared to the baseline visit. The amount of patients who decreased the dose are reported.
Time frame: 12 Months
Change in Quality of Life
Subjects were provided with the Euroqol-5 dimensions (EQ-5D) questionnaire at baseline and 12 Months follow-up visit. In that questionnaire, subjects were asked to indicate a score for their health on a scale where 100 would mean 'the best state he/she can imagine' and 0 would be the 'worst state he/she can imagine).
Time frame: Baseline and 12 Months
Rate of Serious Adverse Events and/or Procedure/Device-related Adverse Events
Adverse device effects were defined as adverse events related to the study procedures or the device. Serious events were those that resulted in-patient or prolonged hospitalization or were life-threatening.
Time frame: from enrollment to 12 months follow up
Paresthesia Mapping at 3 Months Compared to the Empower Study
Paresthesia mapping is expressed in percent of paresthesia areas as indicated by the patient on a gender specific body diagram. 87 subjects with Burst stimulation at 3 Months (Prodigy-I) were compared to 134 subjects with tonic stimulation at 3 Months (Empower).
Time frame: 3 Months