Efficacy of Spinal Cord Stimulation in Patients With a Failed Back Surgery Syndrome.

Study Overview
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Brief Summary
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When patients suffer from chronic pain after multiple back surgeries, this is denominated as the 'failed back surgery syndrome'. A possible treatment for these patients is spinal cord stimulation. This is an invasive treatment where no other treatment options (medication, minimal invasive treaments) can offer progress to the patients' health status. In spinal cord stimulation, an electrode will be placed at the spinal cord under local anaesthesia whereas via a battery a painless electrical stimulation will arise. Clinical research have demonstrated that a new way of spinal cord stimulation can improve back and leg pain significantly. This will lead to a better quality of life for the patients and a decreased use of medications. In Ziekenhuis Oost-Limburg, different manners of spinal cord stimulation will be compared to each other.

Detailed Description
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Three different groups of spinal cord stimulation will be compared BASE - High Density Stimulation - Sham BASE - Conventional stimulation- HDS BASE - Sham - High Density Stimulation BASE consists of the baseline where no intervention of stimulation will occur. Sequentially, two phases will follow which will last 7 days per phase. The conventional stimulation is the stimulation that is generally used. The high density stimulation is the new spinal cord stimulation offering lots of advantages improving quality of life. The 3 different study designs will be compared against each other according to a questionnaire including pain, need for medication, sleep quality, quality of life, effectiveness.

Official Title
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The Efficacy of Spinal Cord Stimulation in Patients With a Failed Back Surgery Syndrome.

Conditions
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Back Pain, Spinal Cord Stimulation

Intervention / Treatment
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* Device: Spinal cord stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with an implanted neurostimulation system met een FBSS met geïmplanteerd Exclusion Criteria: no knowledge of the Dutch language Addicted to drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: SHAM<br>No stimulation will be given | Device: Spinal cord stimulation<br>* Spinal cord stimulation will be given according to the arms of the group (no stimulation, high density stimulation of conventional stimulation)<br>|
| Experimental: High Density Stimulation<br>New way of spinal cord stimulation | Device: Spinal cord stimulation<br>* Spinal cord stimulation will be given according to the arms of the group (no stimulation, high density stimulation of conventional stimulation)<br>|
| Active Comparator: Conventional stimulation<br>the most used stimulation of the spinal cord | Device: Spinal cord stimulation<br>* Spinal cord stimulation will be given according to the arms of the group (no stimulation, high density stimulation of conventional stimulation)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of pain | Pain will be evaluated in the different groups according to a pain scale varying from 1 to 11 with 0 no pain and 11 a lot of pain | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need of medication | The difference in medication in the different groups will be assessed using a questionnaire | 28 days | 
| Quality of life | Quality of life will be assessed according to a questionnaire | 28 days | 
| Quality of sleep | Quality of sleep will be assessed according to a questionnaire | 28 days |