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The purpose of this study is to evaluate the therapeutic efficacy of microdosing BurstDR stimulation in spinal cord stimulation (SCS) patients with chronic intractable back and/or leg pain.
Microdosing BurstDR consists of periods during which stimulation is delivered with standard BurstDR stimulation parameters alternated with periods during which no stimulation is being delivered.
In this study the investigators propose to evaluate therapeutic efficacy of BurstDR microdosing, and determine optimal microdosing programming parameters in chronic pain patients, who are eligible for SCS therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microdosing group | Experimental | Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. | Device | BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Analog Scale Pain (VAS) Scores Between Baseline and Trial Stimulation | Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable) | baseline and 1 week after trial lead implant (trial stimulation) |
| Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 1 | Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable) | Baseline and 1 month follow up visit |
| Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 2 | Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable) | Baseline and 3 month follow up visit |
| Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 3 | Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable) | Baseline and 6 month follow up visit |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life Between Baseline and Trial Stimulation | Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life) | Baseline and 1 week after trial lead implant (trial stimulation) |
| Measure | Description | Time Frame |
|---|---|---|
| Stimulation ON/OFF Ratio | Percentage of patients using each ON/OFF ratio | 6 month follow up visit |
Inclusion Criteria:
Exclusion Criteria:
Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease, post-herpetic neuralgia or uncontrolled diabetes mellitus;
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| Name | Affiliation | Role |
|---|---|---|
| Timothy R Deer, MD | The Center for Pain Relief | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thrive Clinic | Santa Rosa | California | 95403 | United States | ||
| Nevada advanced pain specialists |
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| ID | Title | Description |
|---|---|---|
| FG000 | Microdosing Group | Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Included subjects that started the SCS trial (50). One subjects had missing demographic data
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| ID | Title | Description |
|---|---|---|
| BG000 | Microdosing Group | Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients. |
| 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 | Change in Visual Analog Scale Pain (VAS) Scores Between Baseline and Trial Stimulation | Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable) | Change in visual analogue scale score between baseline and spinal cord stimulation (SCS) trial missing data for 3 subjects | Posted | Mean | Standard Deviation | units on a scale | baseline and 1 week after trial lead implant (trial stimulation) |
|
From enrollment to completion of the study at 6 month follow up.
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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 | Microdosing Group | Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Subject fractured <1 vertebrae (compression) and was hospitalized overnight | Injury, poisoning and procedural complications | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Trial lead migration | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Filippo Agnesi | Abbott | +19725264860 | 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 | May 19, 2017 | Feb 18, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010148 | Pain, Intractable |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Change in Quality of Life Between Baseline and Follow up 1 |
Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life) |
| Baseline and 1 month follow up visit |
| Change in Quality of Life Between Baseline and Follow up 2 | Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life) | Baseline and 3 month follow up visit |
| Change in Quality of Life Between Baseline and Follow up 3 | Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life) | Baseline and 6 month follow up visit |
| Change in Disability Index Between Baseline and Trial Stimulation | questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability) | Baseline and 1 week after trial lead implant (trial stimulation) |
| Change in Disability Index Between Baseline and and Follow up 1 | questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability) | Baseline and 1 month follow up visit |
| Change in Disability Index Between Baseline and and Follow up 2 | questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability) | Baseline and 3 month follow up visit |
| Change in Disability Index Between Baseline and and Follow up 3 | questionnaire on disability (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability) | Baseline and 6 month follow up visit |
| Change in Pain Catastrophizing Scale Between Baseline and Trial Stimulation | Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising) | Baseline and 1 week after trial lead implant (trial stimulation) |
| Change in Pain Catastrophizing Scale Between Baseline and Follow up 1 | Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising) | Baseline and 1 month follow up visit |
| Change in Pain Catastrophizing Scale Between Baseline and Follow up 2 | Questionnaire on pain catastrophizing (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising) | Baseline and 3 month follow up visit |
| Change in Pain Catastrophizing Scale Between Baseline and Follow up 3 | Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising) | Baseline and 6 month follow up visit |
| Reno |
| Nevada |
| 89511 |
| United States |
| OnSite Clinical Solutions | Asheville | North Carolina | 28803 | United States |
| Ambulatory Surgery Center of Killeen | Killeen | Texas | 76542 | United States |
| Premier Pain Solutions | Charleston | West Virginia | 25301 | United States |
| Non compliance |
|
| Denial by insurance |
|
| Adverse Event |
|
| Trial failure |
|
| Did not proceed to permanent implant |
|
| Withdrawal by Subject |
|
| Subject moving out of state |
|
| Lost to Follow-up |
|
| Lack of Efficacy |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| duration of pain | One subject had missing data for duration of pain | Mean | Standard Deviation | years |
|
|
|
| Primary | Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 1 | Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable) | Change in VAS score between baseline and 1 month follow up missing data for 2 subjects | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 month follow up visit |
|
|
|
| Primary | Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 2 | Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable) | Change in VAS between baseline and 3 month follow up missing data for 2 subject | Posted | Mean | Standard Deviation | units on a scale | Baseline and 3 month follow up visit |
|
|
|
| Primary | Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 3 | Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable) | Change in VAS score between baseline and 6 months visit | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 month follow up visit |
|
|
|
| Secondary | Change in Quality of Life Between Baseline and Trial Stimulation | Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life) | Change in EQ-5D score between baseline and SCS trial 1 subject had missing data | Posted | Mean | Standard Deviation | score on a scale | Baseline and 1 week after trial lead implant (trial stimulation) |
|
|
|
| Secondary | Change in Quality of Life Between Baseline and Follow up 1 | Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life) | Change in EQ-5D score between baseline and 1 month follow up Two subjects had missing data | Posted | Mean | Standard Deviation | score on a scale | Baseline and 1 month follow up visit |
|
|
|
| Secondary | Change in Quality of Life Between Baseline and Follow up 2 | Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life) | Change in EQ-5D score between baseline and 3 month follow up One subjects had missing data | Posted | Mean | Standard Error | score on a scale | Baseline and 3 month follow up visit |
|
|
|
| Secondary | Change in Quality of Life Between Baseline and Follow up 3 | Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life) | Change in EQ-5D score between baseline and 6 month follow up | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 month follow up visit |
|
|
|
| Secondary | Change in Disability Index Between Baseline and Trial Stimulation | questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability) | Change in ODI score between baseline and SCS trial 3 subjects had missing data | Posted | Mean | Standard Deviation | score on a scale | Baseline and 1 week after trial lead implant (trial stimulation) |
|
|
|
| Secondary | Change in Disability Index Between Baseline and and Follow up 1 | questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability) | Change in ODI score between baseline and 1 month follow up 2 subjects had missing data | Posted | Mean | Standard Deviation | score on a scale | Baseline and 1 month follow up visit |
|
|
|
| Secondary | Change in Disability Index Between Baseline and and Follow up 2 | questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability) | Change in disability score between baseline and 3 month follow up Two subjects had missing data | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 month follow up visit |
|
|
|
| Secondary | Change in Disability Index Between Baseline and and Follow up 3 | questionnaire on disability (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability) | Change in disability score between baseline and 6 month follow up | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 month follow up visit |
|
|
|
| Secondary | Change in Pain Catastrophizing Scale Between Baseline and Trial Stimulation | Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising) | Change in PCS between baseline and SCS trial One subject had missing data | Posted | Mean | Standard Deviation | score on a scale | Baseline and 1 week after trial lead implant (trial stimulation) |
|
|
|
| Secondary | Change in Pain Catastrophizing Scale Between Baseline and Follow up 1 | Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising) | Change in PCS score between baseline and 1 month follow up 2 subjects had missing data | Posted | Mean | Standard Deviation | score on a scale | Baseline and 1 month follow up visit |
|
|
|
| Secondary | Change in Pain Catastrophizing Scale Between Baseline and Follow up 2 | Questionnaire on pain catastrophizing (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising) | Change in PCS between baseline and 3 month follow up 2 subjects had missing data | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 month follow up visit |
|
|
|
| Secondary | Change in Pain Catastrophizing Scale Between Baseline and Follow up 3 | Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising) | Change in PCS score between baseline and 6 month follow up 1 subject had missing data | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 month follow up visit |
|
|
|
| Other Pre-specified | Stimulation ON/OFF Ratio | Percentage of patients using each ON/OFF ratio | Posted | Count of Participants | Participants | 6 month follow up visit |
|
|
|
| 0 |
| 60 |
| 2 |
| 60 |
| 3 |
| 60 |
|
| Hospitalization for abdominal pain | General disorders | Non-systematic Assessment |
|
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| subjects using 120 seconds OFF intervals |
|
| subjects using 90 seconds OFF intervals |
|