LaminectomyNCT03702010

Spinal Cord Stimulation in Patients With Post-Laminectomy Syndrome in Testing Phase

A study testing spinal cord stimulation conventional and spinal cord stimulation experimental in people with Laminectomy and Post-laminectomy Syndrome, run by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Laminectomy, Post-laminectomy Syndrome, Spinal Cord Syndrome
What is being tested?: spinal cord stimulation conventional and spinal cord stimulation experimental
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 2 sitesSpain
Study dates: 20 Nov 2018to 1 Jul 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Patients over 18 years of age.
Patients with FBSS syndrome with leg pain or leg and back pain.
Get a score on the visual analogue scale (VAS) ≥ 7.
Have received medical pharmacological treatment for at least 6 months after back surgery.
The patient has signed the informed consent form.

Who cannot join

Patients under 18 years of age.
Patients who require a diathermic energy source (microwave, ultrasound or short wave).
Patients with a pacemaker.
Patients carrying a defibrillator.
Patient with a cochlear implant.
Patients with other active implanted devices.

Show all 12Show fewer

Patients who are scheduled to have any of the following procedures during the study period: an MRI, defibrillation or cardioversion, electrocautery, lithotripsy, radiofrequency or microwave ablation, and any other high-frequency ultrasound procedure,
Women of childbearing age who do not use adequate contraception.
Pregnant or breastfeeding.
Participation in another trial.
Patients who have expressed a desire not to participate in the study and have not formed informed consent.
Patients with a failed spinal cord stimulation implant previously

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

Hospital San Pedro de Logroño
Logroño, La Rioja, 26006
Complejo Asistencial Universitario de Salamanca
Salamanca, 37007

Other trials in Spain

About this study

Official title: Randomized, Single-blind, Multicenter, Crossover, Controlled Clinical Trial to Compare Difference on the Visual Analogue Scale With Two Modes of Spinal Cord Stimulation in Patients With Post-Laminectomy Syndrome in Testing Phase

Traditionally, pain relief through spinal cord stimulation has been associated with the appearance of paresthesia in the affected area. Several parameters are set to maximize the overexposure zone, such as frequency,and pulse width. Although this technique has improved pain in many patients, paresthesia itself can be uncomfortable. Traditionally, the occurrence of paresthesias has been considered to be a predictor of success in pain elimination, while the non-occurrence of paresthesias would indicate failure. So far, few studies have reported pain relief below the threshold of onset of paresthesia. Some clinical trials for pathologies other than the one considered in this study have achieved relief below the threshold by reducing the amplitude of the stimulus. Recently, however, it has been observed in a pilot study that, by increasing the frequency of spinal cord stimulation to 1 kilohertz, it is possible to significantly improve pain relief compared to less frequent conventional stimulation based on the occurrence of paresthesias.

A recent review by the Cochrane Library concluded that conventional spinal cord stimulation for pain relief of Failed Back Surgery Syndrome (or FBSS) requires further clinical studies and better designs to demonstrate its superiority over other therapeutic options. Therefore, although spinal cord stimulation is accepted by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), new techniques are being introduced that offer better results in terms of pain relief. Among these techniques, there is the high frequency mode, which allows avoiding the annoying sensation of paresthesia that substitutes pain with the conventional technique. In order to provide greater rigour and scientific quality, the present study is proposed, in which the conventional spinal cord stimulation (CME) technique (control branch or CME) is compared with paresthesias and a standard frequency (60 hertz) with a high frequency (1000 hertz) EVOLVE system (Evolve workflow - standardized guidance to simplify the trial and implant experience and optimize patient outcomes) (experimental branch or EME) by means of a design with a high degree of scientific evidence, randomising the global sample of patients to each of the two branches of stimulation in the study (blind to the patient) and crossing the branches after a period of washing

Conditions: Laminectomy, Post-laminectomy Syndrome, Spinal Cord Syndrome, Failed Back Surgery Syndrome
Being tested: spinal cord stimulation conventional, spinal cord stimulation experimental
Keywords: Spinal cord stimulation, Back surgery, Chronic pain
Medical subject headings: post laminectomy syndrome, Spinal Cord Injuries, Failed Back Surgery Syndrome, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

spinal cord stimulation conventionalDevice
Also called CME
If the patient has been assigned to the branch of the CME control group, after mapping the search for the pain zone, the neurostimulator is programmed to conventional stimulation.
spinal cord stimulation experimentalDevice
Also called EME
If the patient has been randomized to the branch of the EME experimental group, after a mapping of the search for the pain zone, a 90% subthreshold stimulation is programmed.

Study groups in NCT03702010
Study group	Role	What they receive
CME branch	Active comparator	In this study, the conventional spinal cord stimulation method (control Branch-CME branch) Receives: Device: spinal cord stimulation conventional
EME branch	Experimental	In this study, the experimental spinal cord stimulation method are used in the same patient with the EVOLVE programming guide (EME branch) Receives: Device: spinal cord stimulation experimental

What is being measured

The primary outcome is the main question the study is designed to answer.

Comparing Visual Analogue Scale (VAS)
Visual analogue scale (VAS) at the end of each test phase (either with conventional spinal cord stimulation or with EVOLVE). VAS consists of a 10 centimeter (cm) line, whose ends are defined as the extreme limits of pain (left end corresponds with the absence of pain and the right end with the maximum amount of pain).
The patient is asked to point out in the line the place that better correspond to his/her pain, ranging from 0 to 10.
Measured: Baseline, After first stimulation (5days), after washout and second stimulation (12 days), After 30-day follow-up (42 days)

Secondary outcomes (3)

Change (%) in VAS Scale at the End of Treatment.
Change (%) in Visual Analogue Scale (VAS) at the end of treatment.
- Δ = [(VAS Initial Visit - VAS Final Visit) / VAS initial visit] *100
Please note that positive values indicate a decrease in the VAS scale, which would indicate pain relief, as it was calculated as the value at the earlier time point minus the value at the later time point.
Measured: After first stimulation (Five days after baseline), After second stimulation (12 days after baseline), at the end of follow-up (42 days after baseline)
Evaluation Disability
Oswestry Disability Index of the patients: it is a questionnaire consisting of 10 questions with 6 possible answers each. Every answer gives a punctuation from 0 (less disability) to 5 (more disability).
This scale is expressed in percentage in which 0 percentage (%) would the least disability and 100 percentage (%) would represent the maximum disability.
Measured: Baseline, After first stimulation (+5 days), After washout and second stimulation (+12 days), at the end of follow-up (+42days)
Number of Participants With Adverse Events in Each Arm
Considering as an adverse event those that result in death, or in severe harm to patient's health (lesion that threatens life, permanent harm on an organ or corporal function, or process that needs a medical or surgical intervention to avoid permanent harm)
Measured: 42 days from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Nov 20181 Jul 2020

First posted10 Oct 2018
Study start20 Nov 2018
Primary completion1 Jul 2020
Study completion1 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for LaminectomyStudies 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: Health services research
Allocation: Randomised
Intervention model: Crossover
Model description: Single-blind, multicenter, crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03702010
Sponsor's protocol ID: EST-MED-2018-01
Other IDs: E.C.P.S. 18/1398
Status last verified: Aug 2021
First submitted: 25 Sep 2018
Last updated: 1 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationPhase 4
Comparing Outcomes in Patients Who Have Spinal Surgery Who Have No-Ice Cold and Compression Therapy Using the NICE1 Device Versus Standard of Care
Spinal Surgery, Spinal Fusion
Recruiting
Activity Post Spinal Surgery Engagement Trial
Spinal Surgery for Lumbar Spinal Stenosis (LSS)
Active, not recruiting
SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion
Lumbar Spondylolisthesis, Grade 1 Spondylolisthesis
Not yet recruiting
Virtual Pain Education for Spinal Cord Stimulation Patients
Chronic Pain, Chronic Pain Due to Injury
Not yet recruiting
Guided Laminectomy With Augmented Duroplasty for Acute Traumatic Spinal Cord Injury
Spinal Cord Injury, Acute Spinal Cord Injury (SCI)

All Laminectomy trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Single-blind, Multicenter, Crossover, Controlled Clinical Trial to Compare Difference on the Visual Analogue Scale With Two Modes of Spinal Cord Stimulation in Patients With Post-Laminectomy Syndrome in Testing Phase
ClinicalTrials.gov ID: NCT03702010
Acronym / sponsor ID: EST-MED-2018-01
Conditions: Laminectomy, Post-laminectomy Syndrome, Spinal Cord Syndrome, Failed Back Surgery Syndrome
Keywords: Spinal cord stimulation, Back surgery, Chronic pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y LeónUniversity, hospital or other
Collaborators: Instituto de Investigación Biomédica de Salamanca
Study start: 20 Nov 2018 (actual)
Primary completion: 1 Jul 2020 (actual)
Study completion: 1 Jul 2020 (actual)
First posted: 10 Oct 2018 (actual)
Results: Posted 1 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2
Model description: Single-blind, multicenter, crossover

Arm	Type	Receives
CME branch	Active comparator	Device: spinal cord stimulation conventionalIn this study, the conventional spinal cord stimulation method (control Branch-CME branch)
EME branch	Experimental	Device: spinal cord stimulation experimentalIn this study, the experimental spinal cord stimulation method are used in the same patient with the EVOLVE programming guide (EME branch)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patients over 18 years of age.
Patients with FBSS syndrome with leg pain or leg and back pain.
Get a score on the visual analogue scale (VAS) ≥ 7.
Have received medical pharmacological treatment for at least 6 months after back surgery.
The patient has signed the informed consent form.

Key exclusion criteria (12 listed)

Patients under 18 years of age.
Patients who require a diathermic energy source (microwave, ultrasound or short wave).
Patients with a pacemaker.
Patients carrying a defibrillator.
Patient with a cochlear implant.

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 stimulation conventionalAlso: CMEIf the patient has been assigned to the branch of the CME control group, after mapping the search for the pain zone, the neurostimulator is programmed to conventional stimulation.	Device	CME branch
spinal cord stimulation experimentalAlso: EMEIf the patient has been randomized to the branch of the EME experimental group, after a mapping of the search for the pain zone, a 90% subthreshold stimulation is programmed.	Device	EME branch

Primary outcome

Comparing Visual Analogue Scale (VAS)
Time frame: Baseline, After first stimulation (5days), after washout and second stimulation (12 days), After 30-day follow-up (42 days)
Visual analogue scale (VAS) at the end of each test phase (either with conventional spinal cord stimulation or with EVOLVE). VAS consists of a 10 centimeter (cm) line, whose ends are defined as the extreme limits of pain (left end corresponds with the absence of pain and the right end with the maximum amount of pain). The patient is asked to point out in the line the place that better correspond to his/her pain, ranging from 0 to 10.

3 secondary outcomes

Change (%) in VAS Scale at the End of Treatment.
Time frame: After first stimulation (Five days after baseline), After second stimulation (12 days after baseline), at the end of follow-up (42 days after baseline)
Evaluation Disability
Time frame: Baseline, After first stimulation (+5 days), After washout and second stimulation (+12 days), at the end of follow-up (+42days)
Number of Participants With Adverse Events in Each Arm
Time frame: 42 days from baseline

Results and safety

Results posted to the registry on 1 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CME - EME Branch	13	13
EME - CME Branch	14	14

Primary outcome: Comparing Visual Analogue Scale (VAS)

Time frame: Baseline, After first stimulation (5days), after washout and second stimulation (12 days), After 30-day follow-up (42 days). Mean (Standard Deviation). Unit: score on a scale

Measure	CME -EME Branch n = 13	EME-CME Branch n = 14
Baseline	9.3 (1.1)	8.6 (1.0)
After first stimulation (day +5)	5.7 (1.7)	4.9 (2.3)
After washout and second stimulation (day +12)	5.5 (2.2)	5.2 (2.4)
After Follow-up (day +42)	4.6 (1.8)	4.2 (2.2)

CME -EME Branch vs EME-CME Branch: p = 0.112, t-test, 2 sided
CME -EME Branch vs EME-CME Branch: p = 0.323, t-test, 2 sided
CME -EME Branch vs EME-CME Branch: p = 0.760, t-test, 2 sided

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline to the end of Follow-up (42 days).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CME - Conventional Stimulation	0 of 27 (0%)	3 of 27 (11.1%)	0 of 27
EME - EVOLVE Experimental Stimulation	0 of 27 (0%)	4 of 27 (14.8%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Laminectomy

Enrolling by invitationPhase 4
Comparing Outcomes in Patients Who Have Spinal Surgery Who Have No-Ice Cold and Compression Therapy Using the NICE1 Device Versus Standard of Care
Spinal Surgery, Spinal Fusion
Recruiting
Activity Post Spinal Surgery Engagement Trial
Spinal Surgery for Lumbar Spinal Stenosis (LSS)
Active, not recruiting
SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion
Lumbar Spondylolisthesis, Grade 1 Spondylolisthesis
Not yet recruiting
Virtual Pain Education for Spinal Cord Stimulation Patients
Chronic Pain, Chronic Pain Due to Injury
Not yet recruiting
Guided Laminectomy With Augmented Duroplasty for Acute Traumatic Spinal Cord Injury
Spinal Cord Injury, Acute Spinal Cord Injury (SCI)

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.

Francisco J Sánchez-Montero, MD study director

IBSAL-Instituto de Investigación Biomédica de Salamanca

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 12 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 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. 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?

Yes. Results are posted in the registry (first posted 1 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Comparing Visual Analogue Scale (VAS) (time frame: Baseline, After first stimulation (5days), after washout and second stimulation (12 days), After 30-day follow-up (42 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 NCT03702010.

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 1 Sep 2021.