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

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.

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 Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Procedure: Burst and Tonic stimulation

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Caulfield, Australia, 3162
    • Metro Spinal Clinic
  • Frankston, Australia
    • Frankston Pain Management
  • Richmond, Australia
    • Epworth Hospital
• Belgium
  • Antwerp
    • Wilrijk, Antwerp, Belgium, 2610
      • St Augustinus Ziekenhuis
• Germany
  • Duesseldorf, Germany
    • University Hospital
  • Gera, Germany, 07548
    • Hospital Gera
  • Köln, Germany
    • Medizinische Einrichtungen der Universität zu Köln
  • Magdeburg, Germany
    • Universitätsklinik für Stereataktische Neurochirurgie
  • Tubingen, Germany, 72076
    • Universitätsklinikum Tübingen
• Ireland
  • Dublin, Ireland
    • St Vincents University Hospital
• Italy
  • Napoli, Italy
    • Azienda Ospedaliera Monaldi
  • Pisa, Italy, 56126
    • Az. Ospedaliero-Universitaria Pisana - Stabilimento Santa Chiara
  • Roma, Italy, 00184
    • Az. Osp.S.Giovanni Addolorata
• Netherlands
  • Enschede, Netherlands
    • Medisch Spectrum Twente
  • Nieuwegein, Netherlands
    • St Antonius Ziekenhuis
  • Velp, Netherlands
    • Stichting Alysis Zorggroep
• Spain
  • Sevilla, Spain, 28108
    • Hospital Virgen de Rocio
• Sweden
  • Uppsala, Sweden, 75 185
    • University Hospital
• United Kingdom
  • Leeds, United Kingdom, LS146UH
    • Seacroft Hospital
  • London, United Kingdom, EC 1A 7 BE
    • St Bartolomew's
  • Middlesbrough, United Kingdom
    • James Cook University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Study Population

Patients who are indicated for Spinal Cord Stimulation (SCS) and with Failed Back Surgery Syndrome or Chronic Intractable Pain of the Trunk and/or Limbs.

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Burst and Tonic stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	12 Months
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.	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).	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.	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).	3 Months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Tony Van Havenbergh, St Augustinus, Wilrijk, Belgium; Study Director: Devyani Nanduri, Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: May 19, 2014
• First Submitted That Met QC Criteria: May 20, 2014
• First Posted (Estimated): May 21, 2014

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: SCS; Burst stimulation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: NM-13-038-ID-SC