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

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

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.

Study Overview

• Status: Unknown
• Conditions: Back Pain; Spinal Cord Stimulation
• Intervention / Treatment: Device: Spinal cord stimulation

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 Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martine Puylaert, MD PhD; Phone Number: +3289325407; Email: martine.puylaert@zol.be

Study Locations

• Belgium
  • Genk, Belgium, 3600
    • Recruiting
    • Ziekenhuis Oost-Limburg
    • Contact: Martine Puylaert, MD PhD; Email: martine.puylaert@zol.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ziekenhuis Oost-Limburg
• Investigators: Principal Investigator: Martine Puylaert, MD PhD, Ziekenhuis Oost-Limburg

Publications and helpful links

General Publications

• O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: March 1, 2018
• First Submitted That Met QC Criteria: March 9, 2018
• First Posted (Actual): March 12, 2018

Study Record Updates

• Last Update Posted (Actual): March 12, 2018
• Last Update Submitted That Met QC Criteria: March 9, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Back Pain; Failed Back Surgery Syndrome
• Other Study ID Numbers: HDS study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No