Evaluate St Jude Medical Prodigy Neuromodulation for FBSS or Chronic Pain of the Trunk and/or Limbs

Not Applicable

Completed

Conditions: Chronic Pain

Interventions: Procedure: Burst and Tonic stimulation

Registration Number: NCT02143791

Lead Sponsor: Abbott Medical Devices

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 126

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Burst and Tonic stimulation	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.

Primary Outcome Measures

Name	Time	Method
Percentage Change From Baseline in Overall VAS at 3 Months	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 Outcome Measures

Name	Time	Method
Rate of Serious Adverse Events and/or Procedure/Device-related Adverse Events	from enrollment to 12 months follow up	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.
Change in Pain Catastrophizing Scale	12 Months	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.
Pain Relief	12 Months	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.
Number of Participants With Analgesic Reduction	12 Months	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.
Change in Quality of Life	Baseline and 12 Months	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).
Paresthesia Mapping at 3 Months Compared to the Empower Study	3 Months	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).

Trial Locations

Locations (20): Frankston Pain Management
🇦🇺
Frankston, Australia
St Augustinus Ziekenhuis
🇧🇪
Wilrijk, Antwerp, Belgium
University Hospital
🇸🇪
Uppsala, Sweden
Universitatsklinikum Tubingen
🇩🇪
Tubingen, Germany
Stichting Alysis Zorggroep
🇳🇱
Velp, Netherlands
Seacroft Hospital
🇬🇧
Leeds, United Kingdom
Metro Spinal Clinic
🇦🇺
Caulfield, Australia
Epworth Hospital
🇦🇺
Richmond, Australia
Hospital Gera
🇩🇪
Gera, Germany
Medizinische Einrichtungen der Universität zu Köln
🇩🇪
Köln, Germany
Azienda Ospedaliera Monaldi
🇮🇹
Napoli, Italy
Az. Ospedaliero-Universitaria Pisana - Stabilimento Santa Chiara
🇮🇹
Pisa, Italy
Az. Osp.S.Giovanni Addolorata
🇮🇹
Roma, Italy
St Antonius Ziekenhuis
🇳🇱
Nieuwegein, Netherlands
Medisch Spectrum Twente
🇳🇱
Enschede, Netherlands
Hospital Virgen de Rocio
🇪🇸
Sevilla, Spain
St Bartolomew's
🇬🇧
London, United Kingdom
James Cook University Hospital
🇬🇧
Middlesbrough, United Kingdom
Universitätsklinik für Stereataktische Neurochirurgie
🇩🇪
Magdeburg, Germany
St Vincents University Hospital
🇮🇪
Dublin, Ireland