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

NCT01096147 | Completed Phase 4 DMC

• 1 other identifier: Octad study
• Study Type: interventional
• Target: 80
• Locations: 3 countries
• Sites: 8

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

Conditions

Failed Back Surgery Syndrome

Keywords

FBSS; chronic pain; leg pain; low back pain; spinal cord stimulation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• adverse events related to SCS

  12 months

• quality of life

  12 months

• sleep

  12 months

• pain medication intake

  12 months

• Healthcare resource utilization

  12 months

Study Arms (1)

SCS

ACTIVE COMPARATOR

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

Device: Spinal cord stimulation with eight polar electrode

Interventions

Spinal cord stimulation with eight polar electrode DEVICE

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.

Also known as: Spinal column stimulation

SCS

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rik Buschman, PhD: lead

Study Sites (8)

Hospital ZNA Middelheim

Antwerp, 2020, Belgium

Location

Hospital St Jan

Bruges, 8000, Belgium

Location

Hospital Alma Eeklo

Eeklo, 9900, Belgium

Location

University Hospital Gent

Ghent, 9000, Belgium

Location

Hospital Nicolaas

Sint-Niklaas, 9100, Belgium

Location

St Elisabeth

Zottegem, 9620, Belgium

Location

Stavanger University Hospital

Stavanger, 4068, Norway

Location

Shalgrenska Hospital

Gothenburg, 41345, Sweden

Location

MeSH Terms

Conditions

Failed Back Surgery Syndrome; Chronic Pain; Low Back Pain

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Ann Ver Donck, MD PhD

  Hospital St Jan, Brugge, Belgium

  PRINCIPAL INVESTIGATOR

• Kliment P Gatzinsky, MD PhD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

• Roald Baardsen, MD PhD

  University hospital Stavanger, Stavanger, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Scientist

Study Record Dates

• First Submitted: March 8, 2010
• First Posted: March 30, 2010
• Study Start: February 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 4, 2013

Record last verified: 2013-11

Locations

BE (6); NO (1); SE (1)