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

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ClinicalTrials.gov Identifier: NCT03462147
Recruitment Status : Unknown
Verified March 2018 by Ziekenhuis Oost-Limburg.
Recruitment status was:  Recruiting
First Posted : March 12, 2018
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
Ziekenhuis Oost-Limburg

Study Description
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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.

Condition or disease Intervention/treatment Phase
Back Pain Spinal Cord Stimulation Device: Spinal cord stimulation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Device Feasibility
Official Title: The Efficacy of Spinal Cord Stimulation in Patients With a Failed Back Surgery Syndrome.
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018
Arms and Interventions
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Arm Intervention/treatment
Sham Comparator: SHAM
No stimulation will be given
 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)
Experimental: High Density Stimulation
New way of spinal cord stimulation
 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)
Active Comparator: Conventional stimulation
the most used stimulation of the spinal cord
 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)


Outcome Measures
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Primary Outcome Measures :
  1. Evaluation of pain [ Time Frame: 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 :
  1. Need of medication [ Time Frame: 28 days ]
    The difference in medication in the different groups will be assessed using a questionnaire

  2. Quality of life [ Time Frame: 28 days ]
    Quality of life will be assessed according to a questionnaire

  3. Quality of sleep [ Time Frame: 28 days ]
    Quality of sleep will be assessed according to a questionnaire


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • no knowledge of the Dutch language
  • Addicted to drugs
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03462147


Contacts
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Contact: Martine Puylaert, MD PhD +3289325407 martine.puylaert@zol.be

Locations
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Belgium
Ziekenhuis Oost-Limburg Recruiting
Genk, Belgium, 3600
Contact: Martine Puylaert, MD PhD       martine.puylaert@zol.be   
Sponsors and Collaborators
Ziekenhuis Oost-Limburg
Investigators
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Principal Investigator: Martine Puylaert, MD PhD Ziekenhuis Oost-Limburg
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ziekenhuis Oost-Limburg
ClinicalTrials.gov Identifier: NCT03462147    
Other Study ID Numbers: HDS study
First Posted: March 12, 2018    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Failed Back Surgery Syndrome
Back Pain
Pain
 Neurologic Manifestations
Postoperative Complications
Pathologic Processes