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| Name | Class |
|---|---|
| Medizinische Einrichtungen der Universität Düsseldorf | UNKNOWN |
| Klinikum Duisburg GmbH | UNKNOWN |
| NKO Sint-Augustinus Antwerpen | UNKNOWN |
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This purpose of this study is to evaluate the therapeutic efficacy of burst microdosing stimulation paradigms in patients with chronic pain.
This is a prospective, multicenter, randomized, double-blinded crossover study designed to compare conventional burst stimulation parameters to two different burst microdosing paradigms.
Subjects will be randomized 1:1:1 to one of the three groups. Each group will evaluate all 3 stimulation paradigms in different order.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stimulation order 1 | Experimental | Stimulations delivered in following order:
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| Stimulation order 2 | Experimental | Stimulations delivered in following order:
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| Stimulation order 3 | Experimental | Stimulations delivered in following order:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol | Device | Stimulation parameters are reprogrammed from original values to study defined ones |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) for Pain | Standard evaluation of pain intensity. Scale goes from 0 to 100 millimiters. 0 means no pain, 100 means strongest imaginable pain | assessed every 2 weeks after each intervention, for a total of 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| EQ-5D | European Quality of life questionnaire 5 dimensions. Range goes from 0 to 1. 0 represents low quality of life, 1 represents high quality of life | assessed every 2 weeks after each intervention, for a total of 6 weeks |
| Subject Preference |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lalit Venkatesan, Ph.D. | Abbott Medical Devices | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NKO Sint-Augustinus | Antwerp | 2610 | Belgium | |||
| Klinikum Duisburg GmbH |
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27 of the 29 participants received the study intervention. Of those did not receive study intervention, 1 did not meet inclusion/exlusion criteria and 1 was withdrawn for non compliance.
29 patients were screened for elegibility between july 2016 and may 2017 Dusseldorf (GER) and Wilrijk (BEL)
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| ID | Title | Description |
|---|---|---|
| FG000 | Stimulation Order 1 | Stimulations delivered in following order:
Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol: Stimulation parameters are reprogrammed from original values to study defined ones |
| FG001 | Stimulation Order 2 | Stimulations delivered in following order:
Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol: Stimulation parameters are reprogrammed from original values to study defined ones |
| FG002 | Stimulation Order 3 | Stimulations delivered in following order:
Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol: Stimulation parameters are reprogrammed from original values to study defined ones |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (2 Weeks) |
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| Second Intervention (2 Weeks) |
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| Third Intervention (2 Weeks) |
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Baseline information collected from the two patients that exited the study before receiving intervention was included in the basline analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | Baseline characteristics for all subjects |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Analog Scale (VAS) for Pain | Standard evaluation of pain intensity. Scale goes from 0 to 100 millimiters. 0 means no pain, 100 means strongest imaginable pain | Posted | Mean | Standard Deviation | units on a scale | assessed every 2 weeks after each intervention, for a total of 6 weeks |
|
6 weeks
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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 | Standard Burst | reporting "per intervention" adverse events experienced while standard continuous burst was delivered |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bilateral ISG syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment | One subject reported an adverse event 35 days after randomization to Group 2. The subject developed a new pain condition, bilateral ISG syndrome after enrollment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Filippo Agnesi, PhD | Abbott Neuromodulation | 972-526-4860 | filippo.agnesi@abbott.com |
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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 | Mar 2, 2016 | Aug 3, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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questionnaire to identify preferred stimulation paradigm. multiple choice questionnaire. Possible answers were
| assessed 6 weeks after baseline at the last follow up visit |
| Subject Satisfaction | questionnaire on satisfaction with current therapy | assessed every 2 weeks after each intervention, for a total of 6 weeks |
| Percentage of Participants With Adverse Events | assessed over 6 weeks of study participation |
| Duisburg |
| North Rhine-Westphalia |
| 47055 |
| Germany |
| Medizinische Einrichtungen der Universität Düsseldorf | Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
| NOT COMPLETED |
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| NOT COMPLETED |
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| years |
|
| 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 |
|
| Region of Enrollment | Number | participants |
|
Continuously delivered burst SCS |
|
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| Secondary | EQ-5D | European Quality of life questionnaire 5 dimensions. Range goes from 0 to 1. 0 represents low quality of life, 1 represents high quality of life | Posted | Mean | Standard Deviation | score on a scale | assessed every 2 weeks after each intervention, for a total of 6 weeks |
|
|
|
| Secondary | Subject Preference | questionnaire to identify preferred stimulation paradigm. multiple choice questionnaire. Possible answers were
| Posted | Count of Participants | Participants | assessed 6 weeks after baseline at the last follow up visit |
|
|
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| Secondary | Subject Satisfaction | questionnaire on satisfaction with current therapy | Posted | Count of Participants | Participants | assessed every 2 weeks after each intervention, for a total of 6 weeks |
|
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| Secondary | Percentage of Participants With Adverse Events | Posted | Number | percentage of patients with AE | assessed over 6 weeks of study participation |
|
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| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Burst Microdosing 1 | reporting "per intervention" adverse events experienced while burst microdosing 1 was delivered | 0 | 27 | 0 | 27 | 0 | 27 |
| EG002 | Burst Microdosing 2 | reporting "per intervention" adverse events experienced while burst microdosing 2 was delivered | 0 | 26 | 0 | 26 | 1 | 26 |
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| third intervention |
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| no preference |
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| satisfied |
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| very dissatisfied |
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| very satisfied |
|