Back PainHDSNCT03462147
Efficacy of Spinal Cord Stimulation in Patients With a Failed Back Surgery Syndrome.
A study testing Spinal cord stimulation in people with Back Pain and Spinal Cord Stimulation, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Back Pain, Spinal Cord Stimulation
- What is being tested?
- Spinal cord stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteBelgium
- Study dates
- 1 May 2018to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with an implanted neurostimulation system met een FBSS met geïmplanteerd
Who cannot join
- no knowledge of the Dutch language
- Addicted to drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Spinal cord stimulation
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal cord stimulationDevice
Spinal cord stimulation will be given according to the arms of the group (no stimulation, high density stimulation of conventional stimulation)
| Study group | Role | What they receive |
|---|---|---|
| SHAM | Sham comparator | No stimulation will be given Receives: Device: Spinal cord stimulation |
| High Density Stimulation | Experimental | New way of spinal cord stimulation Receives: Device: Spinal cord stimulation |
| Conventional stimulation | Active comparator | the most used stimulation of the spinal cord Receives: Device: Spinal cord stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days
Secondary outcomes (3)
Need of medication
The difference in medication in the different groups will be assessed using a questionnaire
Measured: 28 days
Quality of life and functional outcome
Quality of life will be assessed according to a questionnaire
Measured: 28 days
Quality of sleep
Quality of sleep will be assessed according to a questionnaire
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start1 May 2018
- Primary completion31 Dec 2022
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dieter Mesotten, Ziekenhuis Oost-Limburg
- Investigators
- Martine Puylaert, MD PhD, Principal investigator, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462147
- Sponsor's protocol ID
- HDS study
- Acronym
- HDS
- Status last verified
- May 2025
- First submitted
- 1 Mar 2018
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 34854473
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Spinal Cord Stimulation in Patients With a Failed Back Surgery Syndrome.
- ClinicalTrials.gov ID
- NCT03462147
- Acronym / sponsor ID
- HDS / HDS study
- Conditions
- Back Pain, Spinal Cord Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 12 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| SHAM | Sham comparator | Device: Spinal cord stimulationNo stimulation will be given |
| High Density Stimulation | Experimental | Device: Spinal cord stimulationNew way of spinal cord stimulation |
| Conventional stimulation | Active comparator | Device: Spinal cord stimulationthe most used stimulation of the spinal cord |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with an implanted neurostimulation system met een FBSS met geïmplanteerd
Key exclusion criteria (2 listed)
- no knowledge of the Dutch language
- Addicted to drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal cord stimulationSpinal cord stimulation will be given according to the arms of the group (no stimulation, high density stimulation of conventional stimulation) | Device | Conventional stimulation, High Density Stimulation, SHAM |
Primary outcome
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
3 secondary outcomes
Need of medication
Time frame: 28 days
Quality of life and functional outcome
Time frame: 28 days
Quality of sleep
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Derived from this study: PubMed 34854473O'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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine Puylaert, MD PhD principal investigator
Ziekenhuis Oost-Limburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal cord stimulation in people with Back Pain and Spinal Cord Stimulation, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of pain (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03462147, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.