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

NCT ID: NCT03462147

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2025-04-01

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.

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.

Conditions

Back Pain; Spinal Cord Stimulation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: SINGLE

Study Groups

SHAM

No stimulation will be given

Group Type: SHAM_COMPARATOR

Spinal cord stimulation

Intervention Type: DEVICE

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

High Density Stimulation

New way of spinal cord stimulation

Group Type: EXPERIMENTAL

Spinal cord stimulation

Intervention Type: DEVICE

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

Conventional stimulation

the most used stimulation of the spinal cord

Group Type: ACTIVE_COMPARATOR

Spinal cord stimulation

Intervention Type: DEVICE

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

Interventions

Spinal cord stimulation

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ziekenhuis Oost-Limburg

OTHER

Sponsor Role: lead

Responsible Party

Dieter Mesotten

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martine Puylaert, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Ziekenhuis Oost-Limburg

Locations

Ziekenhuis Oost-Limburg

Genk, , Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 34854473 (View on PubMed)

Other Identifiers

HDS study

Identifier Type: -

Identifier Source: org_study_id