Pain, Back, Pain, Intractable
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEStimulation 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.
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is able to provide informed consent to participate in the study; * Subject diagnosed with chronic intractable pain associated with back and/or limbs; * Subject is 18 years of age or older; * Subject has failed to respond to at least 6 months of conventional treatment which may include pharmacological treatment, physical therapy, epidural injections; * Subject has a back and/or leg pain intensity of at least 6.0 cm out of 10.0 cm on the average back and/or leg pain visual analogue scale at baseline; * Subject's medical record has been evaluated by the Investigator to ensure that the subject is a good candidate for a neurostimulation system; * Subject is on stable pain medications with a total opioid for at least 28 days prior to enrolling in this study, and is willing to stay on those medications with no dose increase until the 3 month visit; * Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all office visits; * Female candidates of child-bearing potential agree to commit to the use of an effective method of contraception (including but not limited to sterilization, barrier devices, oral contraceptives, intrauterine devices (IUDs), condoms, rhythm method, or abstinence) for the duration of the study
Exclusion criteria
Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease, post-herpetic neuralgia or uncontrolled diabetes mellitus; * Subject is currently participating in a clinical investigation that includes an active treatment arm; * Subject has been implanted with or participated in a trial period for a neurostimulation system; * Subject has an infusion pump; * Subject has evidence of an active disruptive psychological or psychiatric disorder as determined as per standard of care; * Subject has a current diagnosis of a progressive neurological disease as determined by the Investigator; * Subject is immunocompromised; * Subject has an existing medical condition that is likely to require repetitive MRI evaluation in the future (i.e. epilepsy, stroke, multiple sclerosis, acoustic neuroma, tumor); * Subject has history of cancer requiring active treatment in the last 12 months; * Subject has an existing medical condition that is likely to require the use of diathermy in the future; * Subject has documented history of allergic response to titanium or silicone; * Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection; * Subject is a female candidates of child bearing potential that are pregnant (confirmed by positive urine/blood pregnancy test); * Subject has life expectancy of less than 6 months; * Subject is involved in an injury claim under current litigation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 3 | Baseline and 6 month follow up visit | Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable) |
| Change in Visual Analog Scale Pain (VAS) Scores Between Baseline and Trial Stimulation | baseline and 1 week after trial lead implant (trial stimulation) | Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable) |
| Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 1 | Baseline and 1 month follow up visit | Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable) |
| Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 2 | Baseline and 3 month follow up visit | Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life Between Baseline and Follow up 3 | Baseline and 6 month follow up visit | 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 Disability Index Between Baseline and Trial Stimulation | Baseline and 1 week after trial lead implant (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 Disability Index Between Baseline and and Follow up 1 | Baseline and 1 month follow up visit | 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 Index Between Baseline and and Follow up 2 | Baseline and 3 month follow up visit | questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability) |
| Change in Pain Catastrophizing Scale Between Baseline and Trial Stimulation | Baseline and 1 week after trial lead implant (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 Pain Catastrophizing Scale Between Baseline and Follow up 1 | Baseline and 1 month follow up visit | 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 Pain Catastrophizing Scale Between Baseline and Follow up 2 | Baseline and 3 month follow up visit | Questionnaire on pain catastrophizing (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising) |
| Change in Pain Catastrophizing Scale Between Baseline and Follow up 3 | Baseline and 6 month follow up visit | 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 Disability Index Between Baseline and and Follow up 3 | Baseline and 6 month follow up visit | questionnaire on disability (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability) |
| Change in Quality of Life Between Baseline and Trial Stimulation | Baseline and 1 week after trial lead implant (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 Quality of Life Between Baseline and Follow up 1 | Baseline and 1 month follow up visit | 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 Quality of Life Between Baseline and Follow up 2 | Baseline and 3 month follow up visit | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Stimulation ON/OFF Ratio | 6 month follow up visit | Percentage of patients using each ON/OFF ratio |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 49 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Denial by insurance | 1 |
| Overall Study | Did not proceed to permanent implant | 3 |
| Overall Study | Inclusion/exclusion violation | 4 |
| Overall Study | Lack of Efficacy | 2 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Non compliance | 2 |
| Overall Study | Protocol Violation | 3 |
| Overall Study | Recommended for other therapies | 2 |
| Overall Study | Subject moving out of state | 1 |
| Overall Study | Trial failure | 12 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Microdosing Group | — |
|---|---|---|
| Age, Continuous | 56.8 years STANDARD_DEVIATION 3.95 | — |
| duration of pain | 9.98 years STANDARD_DEVIATION 3.31 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 49 participants | — |
| Sex: Female, Male Female | 30 Participants | — |
| Sex: Female, Male Male | 19 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 60 |
| other Total, other adverse events | 3 / 60 |
| serious Total, serious adverse events | 2 / 60 |
Outcome results
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)
Time frame: Baseline and 1 month follow up visit
Population: Change in VAS score between baseline and 1 month follow up missing data for 2 subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microdosing Group | Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 1 | -41.07 units on a scale | Standard Deviation 24.74 |
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)
Time frame: Baseline and 3 month follow up visit
Population: Change in VAS between baseline and 3 month follow up missing data for 2 subject
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microdosing Group | Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 2 | -36.56 units on a scale | Standard Deviation 29.53 |
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)
Time frame: Baseline and 6 month follow up visit
Population: Change in VAS score between baseline and 6 months visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microdosing Group | Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 3 | -36.62 units on a scale | Standard Deviation 29.54 |
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)
Time frame: baseline and 1 week after trial lead implant (trial stimulation)
Population: Change in visual analogue scale score between baseline and spinal cord stimulation (SCS) trial missing data for 3 subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microdosing Group | Change in Visual Analog Scale Pain (VAS) Scores Between Baseline and Trial Stimulation | -46.28 units on a scale | Standard Deviation 23.83 |
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)
Time frame: Baseline and 1 month follow up visit
Population: Change in ODI score between baseline and 1 month follow up 2 subjects had missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microdosing Group | Change in Disability Index Between Baseline and and Follow up 1 | -12.76 score on a scale | Standard Deviation 14.5 |
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)
Time frame: Baseline and 3 month follow up visit
Population: Change in disability score between baseline and 3 month follow up Two subjects had missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microdosing Group | Change in Disability Index Between Baseline and and Follow up 2 | -17 score on a scale | Standard Deviation 19.1 |
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)
Time frame: Baseline and 6 month follow up visit
Population: Change in disability score between baseline and 6 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microdosing Group | Change in Disability Index Between Baseline and and Follow up 3 | -15.5 score on a scale | Standard Deviation 16.6 |
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)
Time frame: Baseline and 1 week after trial lead implant (trial stimulation)
Population: Change in ODI score between baseline and SCS trial 3 subjects had missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microdosing Group | Change in Disability Index Between Baseline and Trial Stimulation | -17.6 score on a scale | Standard Deviation 18.15 |
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)
Time frame: Baseline and 1 month follow up visit
Population: Change in PCS score between baseline and 1 month follow up 2 subjects had missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microdosing Group | Change in Pain Catastrophizing Scale Between Baseline and Follow up 1 | -12.17 score on a scale | Standard Deviation 12.83 |
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)
Time frame: Baseline and 3 month follow up visit
Population: Change in PCS between baseline and 3 month follow up 2 subjects had missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microdosing Group | Change in Pain Catastrophizing Scale Between Baseline and Follow up 2 | -13.32 score on a scale | Standard Deviation 14.38 |
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)
Time frame: Baseline and 6 month follow up visit
Population: Change in PCS score between baseline and 6 month follow up~1 subject had missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microdosing Group | Change in Pain Catastrophizing Scale Between Baseline and Follow up 3 | -13.42 score on a scale | Standard Deviation 12.68 |
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)
Time frame: Baseline and 1 week after trial lead implant (trial stimulation)
Population: Change in PCS between baseline and SCS trial One subject had missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microdosing Group | Change in Pain Catastrophizing Scale Between Baseline and Trial Stimulation | -8.98 score on a scale | Standard Deviation 12.3 |
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)
Time frame: Baseline and 1 month follow up visit
Population: Change in EQ-5D score between baseline and 1 month follow up Two subjects had missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microdosing Group | Change in Quality of Life Between Baseline and Follow up 1 | 0.148 score on a scale | Standard Deviation 0.121 |
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)
Time frame: Baseline and 3 month follow up visit
Population: Change in EQ-5D score between baseline and 3 month follow up One subjects had missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microdosing Group | Change in Quality of Life Between Baseline and Follow up 2 | 0.106 score on a scale | Standard Error 0.209 |
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)
Time frame: Baseline and 6 month follow up visit
Population: Change in EQ-5D score between baseline and 6 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microdosing Group | Change in Quality of Life Between Baseline and Follow up 3 | 0.148 score on a scale | Standard Deviation 0.136 |
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)
Time frame: Baseline and 1 week after trial lead implant (trial stimulation)
Population: Change in EQ-5D score between baseline and SCS trial~1 subject had missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microdosing Group | Change in Quality of Life Between Baseline and Trial Stimulation | 0.172 score on a scale | Standard Deviation 0.1625 |
Other Pre-specified
Stimulation ON/OFF Ratio
Percentage of patients using each ON/OFF ratio
Time frame: 6 month follow up visit
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Microdosing Group | Stimulation ON/OFF Ratio | subjects using 360 seconds OFF intervals | 11 Participants |
| Microdosing Group | Stimulation ON/OFF Ratio | subjects using 240 seconds OFF intervals | 3 Participants |
| Microdosing Group | Stimulation ON/OFF Ratio | subjects using 150 seconds OFF intervals | 3 Participants |
| Microdosing Group | Stimulation ON/OFF Ratio | subjects using 120 seconds OFF intervals | 3 Participants |
| Microdosing Group | Stimulation ON/OFF Ratio | subjects using 90 seconds OFF intervals | 4 Participants |