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

Failed Back Surgery Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01096147
• Other study ID #: Octad study
• Status: Completed
• Phase: Phase 4
• First received: March 8, 2010
• Last updated: November 1, 2013
• Start date: February 2010
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Medtronic Neuromodulation Europe
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review BoardNorway: Ethics CommitteeSweden: Institutional Review Board
• Study type: Interventional

Clinical Trial 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:

1. evaluate the effectiveness of SCS with the Octad® lead on chronic pain in Failed Back Surgery Syndrome patients after 12 months of treatment.

2. collect safety data for SCS with the Octad® lead in patients with refractory chronic pain.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Failed Back Surgery Syndrome
• Syndrome

Intervention

Device:
• Spinal cord stimulation with eight polar electrode
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.

Locations

Country	Name	City	State
Belgium	Hospital ZNA Middelheim	Antwerpen
Belgium	Hospital St Jan	Brugge
Belgium	Hospital Alma Eeklo	Eeklo
Belgium	University Hospital Gent	Gent
Belgium	Hospital Nicolaas	Sint-Niklaas
Belgium	St Elisabeth	Zottegem
Norway	Stavanger University Hospital	Stavanger
Sweden	Shalgrenska Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Rik Buschman, PhD

Countries where clinical trial is conducted

Belgium,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months	No
Secondary	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.	12 months	Yes
Secondary	quality of life	Quality of life assessed by EuroQol group - 5 Dimensions (EQ-5D)	12 months	No
Secondary	sleep	Sleep is assessed by a 3 item questionnaire on sleep quality, falling asleep and waking up from pain.	12 months	No
Secondary	pain medication intake	Data will be collected at specific times on health service resourse use of concomitant pain medication such as opioids.	12 months	No
Secondary	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.	12 months	No
Secondary	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.	12 months	No