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

Not Applicable

• Conditions: Back Pain; Spinal Cord Stimulation
• Interventions: Device: Spinal cord stimulation

• Registration Number: NCT03462147
• Lead Sponsor: Ziekenhuis Oost-Limburg

Brief Summary

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

Three different groups of spinal cord stimulation will be compared

1. BASE - High Density Stimulation - Sham

2. BASE - Conventional stimulation- HDS

3. 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.

Study Timeline

• Study Start: 2017-10-01
• Status Verified: 2018-03
• Study First Submitted: 2018-03-01
• Study First Submitted QC: 2018-03-09
• Last Update Submitted: 2018-03-09
• Study First Posted: 2018-03-12
• Last Update Posted: 2018-03-12
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Patients with an implanted neurostimulation system met een FBSS met geïmplanteerd

Exclusion Criteria

• no knowledge of the Dutch language
• Addicted to drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
High Density Stimulation	Spinal cord stimulation	New way of spinal cord stimulation
Conventional stimulation	Spinal cord stimulation	the most used stimulation of the spinal cord
SHAM	Spinal cord stimulation	No stimulation will be given

Primary Outcome Measures

Name	Time	Method
Evaluation of pain	28 days	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

Secondary Outcome Measures

Name	Time	Method
Need of medication	28 days	The difference in medication in the different groups will be assessed using a questionnaire
Quality of life	28 days	Quality of life will be assessed according to a questionnaire
Quality of sleep	28 days	Quality of sleep will be assessed according to a questionnaire

Trial Locations

Locations (1)

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Belgium