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Efficacy Study of the Octapolar Lead in Patients With Failed Back Surgery Syndrome (FBSS) With Chronic Pain

Primary Purpose

Failed Back Surgery Syndrome

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Spinal cord stimulation with eight polar electrode
Sponsored by
Rik Buschman, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Failed Back Surgery Syndrome focused on measuring FBSS, chronic pain, leg pain, low back pain, spinal cord stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. FBSS patients with neuropathic pain in low-back and/or legs who have not reached their therapy goal with other treatment interventions
  2. ≥ 18 years of age
  3. Chronic pain as a result of FBSS that exists for at least 6 months
  4. Mean pain intensity in the legs should be 5 or higher measured on Visual Analogue Scale (VAS).
  5. Patient has been informed of the study procedures and has given written informed consent.
  6. Patient willing to comply with study protocol including attending the study visits.

Exclusion Criteria:

  1. Expected inability of patients to receive or properly operate the spinal cord stimulation system
  2. History of coagulation disorders, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis or morbus Bechterew
  3. Active malignancy
  4. Addiction to any of the following: drugs, alcohol (5E/day) and/or medication
  5. Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator
  6. Immune deficiency (HIV positive, immunosuppressive, etc.)
  7. Life expectancy < 1 year
  8. Local infection or other skin disorder at site of incision
  9. Pregnancy
  10. Other implanted active medical device
  11. Participation in another clinical trial.

Sites / Locations

  • Hospital ZNA Middelheim
  • Hospital St Jan
  • Hospital Alma Eeklo
  • University Hospital Gent
  • Hospital Nicolaas
  • St Elisabeth
  • Stavanger University Hospital
  • Shalgrenska Hospital

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

SCS

Arm Description

patients receiving SCS for chronic leg and/or back pain.

Outcomes

Primary Outcome Measures

Pain suppression in low back and/or leg
Evaluate the evolution of pain control with the octopolar Octad® lead assessed by a decrease in VAS for leg (and low-back pain separately, if applicable) during 12 months follow-up. Actual pain, the least pain during the last week and the worst pain during the last week are scored.

Secondary Outcome Measures

adverse events related to SCS
Clinical (such as surgery related infections) and technical (such as lead fractures) adverse events will be collected continuously in all patients during a period of 12 months post implant.
quality of life
Quality of life assessed by EuroQol group - 5 Dimensions (EQ-5D)
sleep
Sleep is assessed by a 3 item questionnaire on sleep quality, falling asleep and waking up from pain.
pain medication intake
Data will be collected at specific times on health service resourse use of concomitant pain medication such as opioids.
Healthcare resource utilization
Data will be collected at specific times on health service resourse use of concomitant non-drug therapy use, such as physiotherapy, related to FBSS.
preferred stimulation settings
Characterization of pulsegenerator parameters, such as amplitude, pulse width, stimulation frequency, electrode configuration (positive and negative poles), number of stimulation programs, and stimulation duration is done at specific times.

Full Information

First Posted
March 8, 2010
Last Updated
November 1, 2013
Sponsor
Rik Buschman, PhD
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1. Study Identification

Unique Protocol Identification Number
NCT01096147
Brief Title
Efficacy Study of the Octapolar Lead in Patients With Failed Back Surgery Syndrome (FBSS) With Chronic Pain
Official Title
Octad Study: Evaluation of the Effectiveness of the Octopolar Lead in Patients With Failed Back Surgery Syndrome With Low Back and/or Leg Pain During a One Year Follow-up Period
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rik Buschman, PhD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Spinal cord stimulation (SCS) has been used for over 40 years to treat neuropathic pain. Various clinical studies have shown a beneficial effect of SCS on pain in patients with Failed Back Surgery Syndrome (FBSS). Since more than 2 years the 8-contact points Octad lead has been used and replaced the 4-contact points Quad lead. Even though it seems that eight electrodes has potential advantage over the four electrodes in case of lead migration or disease progress, no clinical data have been published on the effectiveness of SCS using the octopolar epidural lead. The Octad study intents to assess the effectiveness and technical performance of SCS with the Octad® lead for treatment of chronic pain. This study is not set up as a comparison study between the Octad lead and other SCS leads, such as the Quad lead, because the Octad lead is used in most eligible FBSS patients as the standard of care lead. The study intends to: evaluate the effectiveness of SCS with the Octad® lead on chronic pain in Failed Back Surgery Syndrome patients after 12 months of treatment. collect safety data for SCS with the Octad® lead in patients with refractory chronic pain.
Detailed Description
The use of Spinal Cord Stimulation (SCS) for pain control has already a history of more than 40 years. In SCS, a lead is positioned in the epidural space on the dorsal aspect of the spinal cord so as to produce stimulation induced paraesthesia in the painful area. During the last decades many articles have been published, clearly indicating the effectiveness and safety of SCS with quadripolar leads in the pain management of chronic neuropathic pain, and in particular Failed Back Surgery Syndrome (FBSS). Randomized controlled trials demonstrated that compared with re-operation, SCS provides effective pain relief for at least 3 years and compared with conventional non-surgical neuropathic pain management for at least 2 years. However, SCS-related complications can occur, that can be divided into surgical complications and hardware complications. The hardware technology has substantially improved over the years. Moreover, electrodes have become smaller in shape and easier to navigate through the epidural space; and finally, internal pulse generators have new programming capabilities and a longer battery life span. All these technological developments led to the application of minimally invasive percutaneous stimulation trials for a variety of patients with chronic neuropathic pain. Turner et al performed a meta-analysis of spinal cord stimulation for failed back surgery syndrome publications and reported hardware complications of 24% lead migration, 7% lead failure and 2% pulse generator failure. While this analysis evaluated studies using older hardware systems, there is first evidence that the rate of these complications is lower currently with new systems. In the recently published PROCESS paper, also using quadripolar electrodes, long term follow-up showed that hardware complications were 14%: lead migration, 3% lead failure and no pulse generator failures. Generally, patients with radicular pain to the lower extremities respond better to spinal cord stimulation than patients with isolated axial low back pain. However, a few studies have shown that axial low back pain in combination with bilateral leg pain, also respond well to spinal cord stimulation. Both four (e.g. quadripolar Quad lead) and eight (e.g. octapolar Octad® lead) electrodes were shown to be effective in treatment of low back and lower extremity pain, with no apparent advantage of one system over the other. In the recent PROCESS study publication, the reduction of SCS on low-back pain was not-statistically significant when compared to baseline. Even though it seems that eight electrodes may have the potential advantage in case of lead migration or disease progress, no clinical data have been published on the effectiveness of SCS using the octopolar epidural lead. The Octad study is a prospective, multi-center, open-label, non-randomized, interventional study designed to assess the effectiveness and technical performance of SCS with the Octad® lead for treatment of chronic pain. This study is not set up as a comparison study between the Octad lead and other SCS leads, such as the Quad lead, because the Octad lead is used in most eligible FBSS patients as the standard of care lead.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Failed Back Surgery Syndrome
Keywords
FBSS, chronic pain, leg pain, low back pain, spinal cord stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SCS
Arm Type
Active Comparator
Arm Description
patients receiving SCS for chronic leg and/or back pain.
Intervention Type
Device
Intervention Name(s)
Spinal cord stimulation with eight polar electrode
Other Intervention Name(s)
Spinal column stimulation
Intervention Description
In SCS a lead is positioned in the epidural space on the dorsal aspect of the spinal cord as to produce electrically induced paraesthesia in the painful area.
Primary Outcome Measure Information:
Title
Pain suppression in low back and/or leg
Description
Evaluate the evolution of pain control with the octopolar Octad® lead assessed by a decrease in VAS for leg (and low-back pain separately, if applicable) during 12 months follow-up. Actual pain, the least pain during the last week and the worst pain during the last week are scored.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
adverse events related to SCS
Description
Clinical (such as surgery related infections) and technical (such as lead fractures) adverse events will be collected continuously in all patients during a period of 12 months post implant.
Time Frame
12 months
Title
quality of life
Description
Quality of life assessed by EuroQol group - 5 Dimensions (EQ-5D)
Time Frame
12 months
Title
sleep
Description
Sleep is assessed by a 3 item questionnaire on sleep quality, falling asleep and waking up from pain.
Time Frame
12 months
Title
pain medication intake
Description
Data will be collected at specific times on health service resourse use of concomitant pain medication such as opioids.
Time Frame
12 months
Title
Healthcare resource utilization
Description
Data will be collected at specific times on health service resourse use of concomitant non-drug therapy use, such as physiotherapy, related to FBSS.
Time Frame
12 months
Title
preferred stimulation settings
Description
Characterization of pulsegenerator parameters, such as amplitude, pulse width, stimulation frequency, electrode configuration (positive and negative poles), number of stimulation programs, and stimulation duration is done at specific times.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: FBSS patients with neuropathic pain in low-back and/or legs who have not reached their therapy goal with other treatment interventions ≥ 18 years of age Chronic pain as a result of FBSS that exists for at least 6 months Mean pain intensity in the legs should be 5 or higher measured on Visual Analogue Scale (VAS). Patient has been informed of the study procedures and has given written informed consent. Patient willing to comply with study protocol including attending the study visits. Exclusion Criteria: Expected inability of patients to receive or properly operate the spinal cord stimulation system History of coagulation disorders, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis or morbus Bechterew Active malignancy Addiction to any of the following: drugs, alcohol (5E/day) and/or medication Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator Immune deficiency (HIV positive, immunosuppressive, etc.) Life expectancy < 1 year Local infection or other skin disorder at site of incision Pregnancy Other implanted active medical device Participation in another clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Ver Donck, MD PhD
Organizational Affiliation
Hospital St Jan, Brugge, Belgium
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kliment P Gatzinsky, MD PhD
Organizational Affiliation
Sahlgrenska University Hospital, Gothenburg, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roald Baardsen, MD PhD
Organizational Affiliation
University hospital Stavanger, Stavanger, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital ZNA Middelheim
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Hospital St Jan
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Hospital Alma Eeklo
City
Eeklo
ZIP/Postal Code
9900
Country
Belgium
Facility Name
University Hospital Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Hospital Nicolaas
City
Sint-Niklaas
ZIP/Postal Code
9100
Country
Belgium
Facility Name
St Elisabeth
City
Zottegem
ZIP/Postal Code
9620
Country
Belgium
Facility Name
Stavanger University Hospital
City
Stavanger
ZIP/Postal Code
4068
Country
Norway
Facility Name
Shalgrenska Hospital
City
Gothenburg
ZIP/Postal Code
41345
Country
Sweden

12. IPD Sharing Statement

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Efficacy Study of the Octapolar Lead in Patients With Failed Back Surgery Syndrome (FBSS) With Chronic Pain

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