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

NCT02143791 | Completed Results

• 1 other identifier: NM-13-038-ID-SC
• Study Type: interventional
• Target: 126
• Locations: 9 countries
• Sites: 21

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.

Conditions

Chronic Pain

Keywords

SCS; Burst stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Pain Relief

  3 Months

• Pain Relief

  6 Months

• Pain Relief

  12 Months

• Change in Pain Catastrophizing Scale

  12 Months

• Number of Participants With Analgesic Reduction

  12 Months

Study Arms (1)

Burst and Tonic stimulation

EXPERIMENTAL

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

Interventions

Burst and Tonic stimulation PROCEDURE

Burst and Tonic stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (21)

Metro Spinal Clinic

Caulfield, 3162, Australia

Location

Frankston Pain Management

Frankston, Australia

Location

Epworth Hospital

Richmond, Australia

Location

St Augustinus Ziekenhuis

Wilrijk, Antwerp, 2610, Belgium

Location

Medizinische Einrichtungen der Universität zu Köln

Cologne, Germany

Location

University Hospital

Düsseldorf, Germany

Location

Hospital Gera

Gera, 07548, Germany

Location

Universitätsklinik für Stereataktische Neurochirurgie

Magdeburg, Germany

Location

Universitatsklinikum Tubingen

Tübingen, 72076, Germany

Location

St Vincents University Hospital

Dublin, Ireland

Location

Azienda Ospedaliera Monaldi

Napoli, Italy

Location

Az. Ospedaliero-Universitaria Pisana - Stabilimento Santa Chiara

Pisa, 56126, Italy

Location

Az. Osp.S.Giovanni Addolorata

Roma, 00184, Italy

Location

Medisch Spectrum Twente

Enschede, Netherlands

Location

St Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

Stichting Alysis Zorggroep

Velp, Netherlands

Location

Hospital Virgen de Rocio

Seville, 28108, Spain

Location

University Hospital

Uppsala, 75 185, Sweden

Location

Seacroft Hospital

Leeds, LS146UH, United Kingdom

Location

St Bartolomew's

London, EC 1A 7 BE, United Kingdom

Location

James Cook University Hospital

Middlesbrough, United Kingdom

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Devyani Nanduri
• Organization: Abbott

devyani.nanduri@abbott.com

+1 510 561 4328

Study Officials

• Tony Van Havenbergh

  St Augustinus, Wilrijk, Belgium

  PRINCIPAL INVESTIGATOR

• Devyani Nanduri

  Abbott Medical Devices

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 21, 2014
• Study Start: June 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: October 1, 2016
• Last Updated: July 8, 2024
• Results First Posted: July 8, 2024

Record last verified: 2024-01

Locations

NL (3); ES (1); IE (1); BE (1); IT (3); SE (1); AU (3); DE (5); GB (3)