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

Back Pain Clinical Trial

— HDS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03462147
• Other study ID #: HDS study
• Status: Recruiting
• Phase: N/A
• First received: March 1, 2018
• Last updated: March 9, 2018
• Start date: October 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2018
• Source: Ziekenhuis Oost-Limburg
• Contact: Martine Puylaert, MD PhD
• Phone: +3289325407
• Email: martine.puylaert[@]zol.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• no knowledge of the Dutch language

• Addicted to drugs

Related Conditions & MeSH terms

• Back Pain
• Failed Back Surgery Syndrome
• Spinal Cord Stimulation

Intervention

Device:
• Spinal cord stimulation
Spinal cord stimulation will be given according to the arms of the group (no stimulation, high density stimulation of conventional stimulation)

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk

Sponsors (1)

Lead Sponsor	Collaborator
Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Need of medication	The difference in medication in the different groups will be assessed using a questionnaire	28 days
Secondary	Quality of life	Quality of life will be assessed according to a questionnaire	28 days
Secondary	Quality of sleep	Quality of sleep will be assessed according to a questionnaire	28 days