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

Detailed Description

The patients in our pain centre are implanted with Medtronic material. This material cannot deliver the 10kHz frequency but can deliver up to 5000 Hz (hereinafter referred to as high density stimulation). This also delivers high energy to the spinal cord without palpable paresthesia, with a beneficial effect on the pain.

We wish to include patients who, in accordance with Belgian regulations, have undergone a normal evaluation period with an external battery and who have subsequently had a definitive system implanted. The implant procedure, evaluation period and the material used are identical to patients outside the study context.

We wish to compare different stimulation modes within a patient population in which an epidural electrode for failed back surgery syndrome (FBSS) has been implanted, in order to evaluate the effectiveness. We will evaluate the modality "high-density", conventional stimulation and sham stimulation in the same patient. This can be easily adjusted by reprogramming the implanted battery. For this study we want to use a relatively new study design, namely: single case design (N-of-1 trial). In this, many variables will be evaluated with a limited number of study subjects in order to determine an effect. We want to investigate to what extent the patient experiences the different stimulation modes and to what extent he can compare or prefer these stimulation modes. The stimulation that the patient prefers as most pleasant can be continued afterwards. If the patient does not experience pain reduction during a certain stimulation mode, he can always fall back on his own pain medication.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Genk, Belgium, 3600
    • Ziekenhuis Oost-Limburg

Participation Criteria

Eligibility Criteria

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

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: Non-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 sleep	Quality of sleep will be assessed according to a questionnaire	28 days
Quality of life and functional outcome	Quality of life 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): May 1, 2018
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): April 1, 2025

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): May 30, 2025
• Last Update Submitted That Met QC Criteria: May 23, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; 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