Failed Back Surgery SyndromeNCT03768791
HRV in Patients Treated With Spinal Cord Stimulation
A study testing SCS is switched off and SCS is switched on in people with Failed Back Surgery Syndrome, run by Moens Maarten at 1 site in Belgium.
Trial summary
This study is an observatory single center study investigating heart rate variability during on and off states of the spinal cord stimulator, in patients with failed back surgery syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Failed Back Surgery Syndrome
- What is being tested?
- SCS is switched off and SCS is switched on
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2018to 21 Dec 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is at least 18 years old.
- Diagnosis of FBSS (Failed conservative treatments for pain including but not limited to pharmacological therapy and physical therapy) and currently being treated with spinal cord stimulation.
- Cognitive and language functioning enabling coherent communication between the examiner and the participant.
Who cannot join
- The presence of one or more coexisting conditions known to affect HRV analysis (including but not limited to atrial fibrillation, numerous atrial or ventricular extra beats, paced rhythm, left ventricular bundle branch block, cancer, kidney or hepatic failure, and diabetes mellitus (autonomic nervous system dysfunction)).
- The use of medication that directly modifies autonomic control (for example beta-blockers).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Heart Rate Variability in Patients With Failed Back Surgery Syndrome, Treated With Spinal Cord Stimulation
This study is an observatory single center study investigating heart rate variability during on and off states of the spinal cord stimulator, in patients with failed back surgery syndrome.
- Conditions
- Failed Back Surgery Syndrome
- Being tested
- SCS is switched off, SCS is switched on
- Keywords
- Spinal Cord Stimulation, Heart rate variability
- Medical subject headings
- Failed Back Surgery Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCS is switched offOther
Spinal cord stimulator is switched off for 12 hours
SCS is switched onOther
Spinal cord stimulator is on
| Study group | Role | What they receive |
|---|---|---|
| SCS off | Experimental | Not described Receives: Other: SCS is switched off |
| SCS on | Experimental | Not described Receives: Other: SCS is switched on |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability changes
The investigators will examine the difference in heart rate variability between both measurements (SCS on versus SCS off)
Measured: Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day.
Secondary outcomes (1)
Pain intensity scores
Pain intensity scores on a visual analogue scale ranging from zero (no pain) towards 10 (worst possible pain).
Measured: Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start1 Dec 2018
- Primary completion21 Dec 2018
- Study completion21 Dec 2018
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 Failed Back Surgery SyndromeStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moens Maarten
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Moens Maarten, Universitair Ziekenhuis Brussel
- Investigators
- Maarten Moens, Prof. dr., Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768791
- Sponsor's protocol ID
- SYNCHRO
- Status last verified
- Jun 2019
- First submitted
- 28 Nov 2018
- Last updated
- 18 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kalmar Z, Kovacs N, Balas I, Perlaki G, Plozer E, Orsi G, Altbacker A, Schwarcz A, Hejjel L, Komoly S, Janszky J. Effects of spinal cord stimulation on heart rate variability in patients with chronic pain. Ideggyogy Sz. 2013 Mar 30;66(3-4):102-6.
PubMed 23750425
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Variability in Patients With Failed Back Surgery Syndrome, Treated With Spinal Cord Stimulation
- ClinicalTrials.gov ID
- NCT03768791
- Acronym / sponsor ID
- SYNCHRO
- Conditions
- Failed Back Surgery Syndrome
- Keywords
- Spinal Cord Stimulation, Heart rate variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Moens MaartenUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 7 Dec 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.
This study is an observatory single center study investigating heart rate variability during on and off states of the spinal cord stimulator, in patients with failed back surgery syndrome.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCS off | Experimental | Other: SCS is switched off |
| SCS on | Experimental | Other: SCS is switched on |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is at least 18 years old.
- Diagnosis of FBSS (Failed conservative treatments for pain including but not limited to pharmacological therapy and physical therapy) and currently being treated with spinal cord stimulation.
- Cognitive and language functioning enabling coherent communication between the examiner and the participant.
Key exclusion criteria (2 listed)
- The presence of one or more coexisting conditions known to affect HRV analysis (including but not limited to atrial fibrillation, numerous atrial or ventricular extra beats, paced rhythm, left ventricular bundle branch block, cancer, kidney or hepatic failure, and diabetes mellitus (autonomic nervous system dysfunction)).
- The use of medication that directly modifies autonomic control (for example beta-blockers).
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 |
|---|---|---|
| SCS is switched offSpinal cord stimulator is switched off for 12 hours | Other | SCS off |
| SCS is switched onSpinal cord stimulator is on | Other | SCS on |
Primary outcome
Heart rate variability changes
Time frame: Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day.
The investigators will examine the difference in heart rate variability between both measurements (SCS on versus SCS off)
1 secondary outcome
Pain intensity scores
Time frame: Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day.
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 18 Jun 2019.
- Background: PubMed 23750425Kalmar Z, Kovacs N, Balas I, Perlaki G, Plozer E, Orsi G, Altbacker A, Schwarcz A, Hejjel L, Komoly S, Janszky J. Effects of spinal cord stimulation on heart rate variability in patients with chronic pain. Ideggyogy Sz. 2013 Mar 30;66(3-4):102-6.
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Failed Back Surgery Syndrome
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.
Maarten Moens, Prof. dr. principal investigator
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCS is switched off and SCS is switched on in people with Failed Back Surgery Syndrome, run by Moens Maarten 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 3 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 18 Jun 2019. 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. 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?
Heart rate variability changes (time frame: Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day.). 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 NCT03768791, 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 18 Jun 2019.