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| ID | Type | Description | Link |
|---|---|---|---|
| E.C.P.S. 18/1398 | Other Identifier | IBSAL (INSTITUTO DE INVESTIGACIÓN BIOMÉDICA DE SALAMANCA) |
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| Name | Class |
|---|---|
| Instituto de Investigación Biomédica de Salamanca | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CME branch | Active Comparator | In this study, the conventional spinal cord stimulation method (control Branch-CME branch) |
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| 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| spinal cord stimulation conventional | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, After first stimulation (5days), after washout and second stimulation (12 days), After 30-day follow-up (42 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Change (%) in VAS Scale at the End of Treatment. | Change (%) in Visual Analogue Scale (VAS) at the end of treatment.
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. | After first stimulation (Five days after baseline), After second stimulation (12 days after baseline), at the end of follow-up (42 days after baseline) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francisco J Sánchez-Montero, MD | IBSAL-Instituto de Investigación Biomédica de Salamanca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital San Pedro de Logroño | Logroño | La Rioja | 26006 | Spain | ||
| Complejo Asistencial Universitario de Salamanca |
27 of 28 patients screened were randomized, as one patient did not meet inclusion/exclusion criteria.
All patients underwent both treatments, as the study design was cross-section.
Planned enrollment: 24. Final enrollment: 27. Screened: 28.
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| ID | Title | Description |
|---|---|---|
| FG000 | CME - EME Branch | In this study, the conventional spinal cord stimulation method (control Branch-CME branch) CME control group: after mapping the search for the pain area, the neurostimulator is programmed to conventional stimulation with paresthesia at 60 Hz and a pulse width between 300-450 μs, for 5 days. The device is then deprogrammed and a 2-day washout period is initiated. On day 7, EME protocol is initiated: stimulation is programmed at 90% of the subthreshold with a pulse width of 90 μs and frequency of 1000 Hz, placing the bipole in the T9-T10 space, for 5 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Stimulation (5 Days) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 4, 2018 |
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Single-blind, multicenter, crossover
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| spinal cord stimulation experimental | Device | 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. |
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| 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. | 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) | 42 days from baseline |
| Salamanca |
| 37007 |
| Spain |
| FG001 | EME - CME Branch | In this study, the experimental spinal cord stimulation method are used in the same patient with the EVOLVE programming guide (EME branch) EME experimental group: fter mapping the search for the pain area, the neurostimulator is programmed at 90% of the subthreshold with a pulse width of 90 μs and frequency of 1000 Hz, placing the bipole in the T9-T10 space, for 5 days. The device is then deprogrammed and a 2-day washout period is initiated. On day 7, conventional CME stimulation is programmed with paresthesia at 60 Hz and a pulse width between 300-450 μs, for 5 days. |
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| NOT COMPLETED |
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| Washout + Second Stimulation (2+5days) |
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| Follow-up (30days) |
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All participants underwent both neurostimulation protocols, as it was a crossover study.
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| ID | Title | Description |
|---|---|---|
| BG000 | CME - EME Branch | After mapping the search for the pain area, the neurostimulator is programmed to conventional stimulation (CME) with paresthesia at 60 Hz and a pulse width between 300-450 μs, for 5 days. The device is then deprogrammed and a 2-day washout period is initiated. On day 7, EME experimental protocol is initiated: stimulation is programmed at 90% of the subthreshold with a pulse width of 90 μs and frequency of 1000 Hz, placing the bipole in the T9-T10 space, for 5 days. |
| BG001 | EME - CME Branch | After mapping the search for the pain area, the neurostimulator is programmed to EME experimental protocol is initiated: stimulation is programmed at 90% of the subthreshold with a pulse width of 90 μs and frequency of 1000 Hz, placing the bipole in the T9-T10 space, for 5 days. The device is then deprogrammed and a 2-day washout period is initiated. On day 7, conventional stimulation (CME) stimulation is programmed with paresthesia at 60 Hz and a pulse width between 300-450 μs, for 5 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, After first stimulation (5days), after washout and second stimulation (12 days), After 30-day follow-up (42 days) |
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| Secondary | Change (%) in VAS Scale at the End of Treatment. | Change (%) in Visual Analogue Scale (VAS) at the end of treatment.
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. | Posted | Mean | Standard Deviation | percentage of VAS change | After first stimulation (Five days after baseline), After second stimulation (12 days after baseline), at the end of follow-up (42 days after baseline) |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, After first stimulation (+5 days), After washout and second stimulation (+12 days), at the end of follow-up (+42days) |
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| Secondary | 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) | Posted | Count of Participants | Participants | 42 days from baseline |
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From baseline to the end of Follow-up (42 days).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CME - Conventional Stimulation | Conventional stimulation with paresthesia at 60 Hz and a pulse width between 300-450 μs, for 5 days. | 0 | 27 | 0 | 27 | 3 | 27 |
| EG001 | EME - EVOLVE Experimental Stimulation | The neurostimulator is programmed to stimulation is programmed at 90% of the subthreshold with a pulse width of 90 μs and frequency of 1000 Hz, placing the bipole in the T9-T10 space, for 5 days. | 0 | 27 | 0 | 27 | 4 | 27 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | Surgical and medical procedures | Systematic Assessment | One patient reported pain in the surgical wound, and also experienced abnormal stimulation. |
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| Electrode migration | Surgical and medical procedures | Systematic Assessment |
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| post-dural puncture headache | Injury, poisoning and procedural complications | Systematic Assessment | two dural punctures resulting in post-dural puncture headache (one episode on each branch) |
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| Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Abnormal stimulation | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Francisco José Sánchez Montero | Hospital Universitario de Salamanca | 923291100 | fjsmontero@saludcastillayleon.es |
| Mar 29, 2021 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 8, 2018 | Mar 29, 2021 | ICF_001.pdf |
| ID | Term |
|---|---|
| C000711512 | post laminectomy syndrome |
| D013119 | Spinal Cord Injuries |
| D055111 | Failed Back Surgery Syndrome |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| After washout and second stimulation (day +12) |
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| After Follow-up (day +42) |
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| 0.323 |
| Superiority |
| After second stimulation | t-test, 2 sided | 0.760 | Superiority |
| End of Follow-up | t-test, 2 sided | 0.624 | Superiority |
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