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

NCT03462147 | Completed

• 1 other identifier: HDS study
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Back Pain; Spinal Cord Stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Need of medication

  28 days

• Quality of life and functional outcome

  28 days

• Quality of sleep

  28 days

Study Arms (3)

SHAM

SHAM COMPARATOR

No stimulation will be given

Device: Spinal cord stimulation

High Density Stimulation

EXPERIMENTAL

New way of spinal cord stimulation

Device: Spinal cord stimulation

Conventional stimulation

ACTIVE COMPARATOR

the most used stimulation of the spinal cord

Device: Spinal cord stimulation

Interventions

Spinal cord stimulation DEVICE

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

Conventional stimulation; High Density Stimulation; SHAM

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• no knowledge of the Dutch language
• Addicted to drugs

Sponsors & Collaborators

• Ziekenhuis Oost-Limburg: lead

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

Related Publications (1)

• 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.

  PMID: 34854473 DERIVED

MeSH Terms

Conditions

Back Pain

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Martine Puylaert, MD PhD

  Ziekenhuis Oost-Limburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: We wish to compare different stimulation modes within a patient population in which an epidural electrode for 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.

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 12, 2018
• Study Start: May 1, 2018
• Primary Completion: December 31, 2022
• Study Completion: April 1, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

BE (1)