Efficacy Study of the Octapolar Lead in Patients With Failed Back Surgery Syndrome (FBSS) With Chronic Pain
CompletedPhase 4NCT01096147
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- 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
- Conditions
- Interventions
- Device: Spinal cord stimulation with eight polar electrode
- Sponsor
- Rik Buschman, PhD
- Organization
- Medtronic Neuromodulation Europe
- Start date
- 2010-02
- Primary completion
- 2013-03
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Belgium, Norway, Sweden
- Total sites listed
- 8
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01096147