Clinical trial NCT01096147: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Failed Back Surgery Syndrome
Keywords: FBSS
chronic pain
leg pain
low back pain
spinal cord stimulation
Lead sponsor: Medtronic Neuromodulation Europe
Sponsor class: INDUSTRY
First posted: 2010-03-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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:

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain suppression in low back and/or leg
timeFrame: 12 months
Secondary outcomes:
measure: adverse events related to SCS
timeFrame: 12 months
measure: quality of life
timeFrame: 12 months
measure: sleep
timeFrame: 12 months
measure: pain medication intake
timeFrame: 12 months
measure: Healthcare resource utilization
timeFrame: 12 months
measure: preferred stimulation settings
timeFrame: 12 months
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Hospital ZNA Middelheim
city: Brugge
country: Belgium
facility: Hospital St Jan
city: Eeklo
country: Belgium
facility: Hospital Alma Eeklo
city: Gent
country: Belgium
facility: University Hospital Gent
city: Sint-Niklaas
country: Belgium
facility: Hospital Nicolaas
city: Zottegem
country: Belgium
facility: St Elisabeth
city: Stavanger
country: Norway
facility: Stavanger University Hospital
city: Gothenburg
country: Sweden
facility: Shalgrenska Hospital
Study officials:
affiliation: Hospital St Jan, Brugge, Belgium
name: Ann Ver Donck, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sahlgrenska University Hospital
name: Kliment P Gatzinsky, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University hospital Stavanger, Stavanger, Norway
name: Roald Baardsen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: