Spinal Cord Stimulation in Patients With Post-Laminectomy Syndrome in Testing Phase
Primary Purpose
Laminectomy, Post-laminectomy Syndrome, Spinal Cord Syndrome
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
spinal cord stimulation conventional
spinal cord stimulation experimental
Sponsored by
About this trial
This is an interventional health services research trial for Laminectomy focused on measuring Spinal cord stimulation, Back surgery, Chronic pain
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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
Sites / Locations
- Hospital San Pedro de Logroño
- Complejo Asistencial Universitario de Salamanca
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
CME branch
EME branch
Arm Description
In this study, the conventional spinal cord stimulation method (control Branch-CME branch)
In this study, the experimental spinal cord stimulation method are used in the same patient with the EVOLVE programming guide (EME branch)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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)
Full Information
NCT ID
NCT03702010
First Posted
September 25, 2018
Last Updated
August 6, 2021
Sponsor
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Collaborators
Instituto de Investigación Biomédica de Salamanca
1. Study Identification
Unique Protocol Identification Number
NCT03702010
Brief Title
Spinal Cord Stimulation in Patients With Post-Laminectomy Syndrome in Testing Phase
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
November 20, 2018 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Collaborators
Instituto de Investigación Biomédica de Salamanca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laminectomy, Post-laminectomy Syndrome, Spinal Cord Syndrome, Failed Back Surgery Syndrome
Keywords
Spinal cord stimulation, Back surgery, Chronic pain
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Single-blind, multicenter, crossover
Masking
Participant
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CME branch
Arm Type
Active Comparator
Arm Description
In this study, the conventional spinal cord stimulation method (control Branch-CME branch)
Arm Title
EME branch
Arm Type
Experimental
Arm Description
In this study, the experimental spinal cord stimulation method are used in the same patient with the EVOLVE programming guide (EME branch)
Intervention Type
Device
Intervention Name(s)
spinal cord stimulation conventional
Other Intervention Name(s)
CME
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
spinal cord stimulation experimental
Other Intervention Name(s)
EME
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparing Visual Analogue Scale (VAS)
Description
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.
Time Frame
Baseline, After first stimulation (5days), after washout and second stimulation (12 days), After 30-day follow-up (42 days)
Secondary Outcome Measure Information:
Title
Change (%) in VAS Scale at the End of Treatment.
Description
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.
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)
Title
Evaluation Disability
Description
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.
Time Frame
Baseline, After first stimulation (+5 days), After washout and second stimulation (+12 days), at the end of follow-up (+42days)
Title
Number of Participants With Adverse Events in Each Arm
Description
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)
Time Frame
42 days from baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco J Sánchez-Montero, MD
Organizational Affiliation
IBSAL-Instituto de Investigación Biomédica de Salamanca
Official's Role
Study Director
Facility Information:
Facility Name
Hospital San Pedro de Logroño
City
Logroño
State/Province
La Rioja
ZIP/Postal Code
26006
Country
Spain
Facility Name
Complejo Asistencial Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Spinal Cord Stimulation in Patients With Post-Laminectomy Syndrome in Testing Phase
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