Chronic Pain
Conditions
Keywords
Chronic Pain, BurstDR, spinal cord stimulation, Accelerometry
Brief summary
The purpose of this study is to assess feasibility of using wearable sensors to capture objective assessments of patient's activity and sleep quality during the spinal cord stimulation (SCS) treatment continuum.
Detailed description
Eligible patients will undergo standard clinical care using BurstDR SCS and will be asked to wear a wrist worn accelerometer for a baseline period, during SCS trial and for 3 months after activation of the SCS stimulation.
Interventions
OTHERAccelerometry
Record of activity levels using a wrist worn accelerometer
Sponsors
AZ Sint-Augustinus, Wilrijk
AZ Middelheim, Antwerpen
Erasmus Medical Center
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is able to provide informed consent to participate in the study; * Subject is 18 years of age or older; * Subject has failed to respond to at least 6 months of conventional treatment including pharmacological treatment, physical therapy, epidural injections and/or radiofrequency therapy; * Subjects with the diagnosis of failed back surgery syndrome or chronic intractable trunk and/or lower limb pain and are eligible for a SCS trial; * Subjects have an average trunk pain VAS score of at least 6.0 out of 10.0, and/or lower limb pain VAS score of at least 6.0 out of 10.0; * Subject is on stable pain medications, as determined by the Investigator, for at least 28 days prior to enrolling in this study, and is willing to stay on those medications with no dose adjustments until activation of the permanently implanted SCS device; * 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 willing to cooperate with the study requirements including compliance with the regimen and completion of all office visits; * Subject agrees to wear the wearable sensor for the duration of the study; * 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 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; * Non- ambulatory subjects who are not expected to become ambulatory after receiving neurostimulation; * Subject diagnosed with fibromyalgia or chronic fatigue; * 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 coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus; * Subject has a current diagnosis of a progressive neurological disease as determined by the Investigator; * Subject is immunocompromised; * Subjects with concurrent clinically significant or disabling chronic pain problem that requires additional treatment; * 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; * Female candidates of child bearing potential that are pregnant (confirmed by positive urine/blood pregnancy test)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Activity Levels | between baseline and the end of spinal cord stimulation trial period (average of 1 month) | Recording performed with wrist worn accelerometer. Medium to Vigorous Physical Activity (MVPA) were calculated based on accelerometry data. MVPA value represents the hours of medium to vigorous physical activity in a day. |
| Change in Sleep Quality | between baseline and the end of spinal cord stimulation trial period (average of 1 month) | Recording performed with wrist worn accelerometer. Sleep duration was calculated based on accelerometry data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Oswestry Disability Index (ODI) | between baseline and the end of spinal cord stimulation trial period (average of 1 month) | Questionnaire pertaining to disability levels. Minimum value 0, maximum value 100 with higher values representing higher levels of disability. |
| Change in Visual Analog Scale (VAS) for Pain | between baseline and the end of spinal cord stimulation trial period (average of 1 month) | Subjective evaluation of pain levels used in clinical practice as standard. Minimum value is 0 (no pain), maximum value is 10 (maximum pain imaginable) |
| Change in Sleep Quality | between baseline and 1 month post permanent spinal cord stimulator activation followup | Recording performed with wrist worn accelerometer. Sleep duration was calculated based on accelerometry data. |
| Change in Activity Levels | between baseline and 1 month post permanent spinal cord stimulator activation followup | Recording performed with wrist worn accelerometer. Medium to Vigorous Physical Activity (MVPA) were calculated based on accelerometry data. MVPA value represents the hours of medium to vigorous physical activity in a day. Average percent change in MVPA from baseline value is reported. |
| Change in European Quality of Life 5 Dimensions (EQ-5D) | between baseline and the end of spinal cord stimulation trial period (average of 1 month) | Questionnaire pertaining to quality of life. Minimum Value 0, maximum value 1 with higher numbers representing higher quality of life. |
Countries
Belgium, Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Activity and Sleep Quality Recording Patients will receive a wrist worn accelerometer and accelerometry will be used to monitor physical activity and sleep quality during standard BurstDR Spinal Cord Stimulation clinical treatment
Accelerometry: Record of activity levels using a wrist worn accelerometer | 27 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | stimulation trail failure | 5 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Activity and Sleep Quality Recording |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Age, Continuous | 51.8 years STANDARD_DEVIATION 11.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 27 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Belgium | 5 participants |
| Region of Enrollment Netherlands | 22 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 27 |
| other Total, other adverse events | 3 / 27 |
| serious Total, serious adverse events | 0 / 27 |
Outcome results
Primary
Change in Activity Levels
Recording performed with wrist worn accelerometer. Medium to Vigorous Physical Activity (MVPA) were calculated based on accelerometry data. MVPA value represents the hours of medium to vigorous physical activity in a day.
Time frame: between baseline and the end of spinal cord stimulation trial period (average of 1 month)
Population: Average change in MVPA (h/day) from baseline value is reported. Activity recording files were not available for 2 patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Activity and Sleep Quality Recording | Change in Activity Levels | -0.17 change in MVPA h/day from baseline value | Standard Deviation 0.22 |
Primary
Change in Sleep Quality
Recording performed with wrist worn accelerometer. Sleep duration was calculated based on accelerometry data.
Time frame: between baseline and the end of spinal cord stimulation trial period (average of 1 month)
Population: Change in average sleep duration from baseline value is reported. Activity recording files were not available for 2 patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Activity and Sleep Quality Recording | Change in Sleep Quality | -0.05 Change h/day from baseline value | Standard Deviation 1.05 |
Secondary
Change in Activity Levels
Recording performed with wrist worn accelerometer. Medium to Vigorous Physical Activity (MVPA) were calculated based on accelerometry data. MVPA value represents the hours of medium to vigorous physical activity in a day. Average percent change in MVPA from baseline value is reported.
Time frame: between baseline and 1 month post permanent spinal cord stimulator activation followup
Population: Average change in MVPA (h/day) from baseline value is reported. Activity recording files were not available for 1 patient
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Activity and Sleep Quality Recording | Change in Activity Levels | -0.01 change in MVPA h/day from baseline value | Standard Deviation 0.09 |
Secondary
Change in Activity Levels
Recording performed with wrist worn accelerometer. Medium to Vigorous Physical Activity (MVPA) were calculated based on accelerometry data. MVPA value represents the hours of medium to vigorous physical activity in a day. Average percent change in MVPA from baseline value is reported.
Time frame: between baseline and 3 month post permanent spinal cord stimulator activation followup
Population: Average change in MVPA (h/day) from baseline value is reported. Activity files were not available for 5 patients
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Activity and Sleep Quality Recording | Change in Activity Levels | 0.02 change in MVPA h/day from baseline value | Standard Deviation 0.08 |
Secondary
Change in Activity Levels
Recording performed with wrist worn accelerometer. Medium to Vigorous Physical Activity (MVPA) were calculated based on accelerometry data. MVPA value represents the hours of medium to vigorous physical activity in a day. Average percent change in MVPA from baseline value is reported.
Time frame: between baseline and 2 month post permanent spinal cord stimulator activation followup
Population: Average change in MVPA (h/day) from baseline value is reported. Activity recording files were not available for 1 patient
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Activity and Sleep Quality Recording | Change in Activity Levels | 0.03 change in MVPA h/day from baseline value | Standard Deviation 0.08 |
Secondary
Change in European Quality of Life 5 Dimensions (EQ-5D)
Questionnaire pertaining to quality of life. Minimum Value 0, maximum value 1 with higher numbers representing higher quality of life
Time frame: between baseline and 1 month post permanent spinal cord stimulator activation followup
Population: Change in average EQ-5D scores from baseline is reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Activity and Sleep Quality Recording | Change in European Quality of Life 5 Dimensions (EQ-5D) | 0.19 change in score on a scale | Standard Deviation 0.17 |
Secondary
Change in European Quality of Life 5 Dimensions (EQ-5D)
Questionnaire pertaining to quality of life. Minimum Value 0, maximum value 1 with higher numbers representing higher quality of life
Time frame: between baseline and 2 month post permanent spinal cord stimulator activation followup
Population: Change in average EQ-5D scores from baseline is reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Activity and Sleep Quality Recording | Change in European Quality of Life 5 Dimensions (EQ-5D) | 0.23 change in score on a scale | Standard Deviation 0.14 |
Secondary
Change in European Quality of Life 5 Dimensions (EQ-5D)
Questionnaire pertaining to quality of life. Minimum Value 0, maximum value 1 with higher numbers representing higher quality of life.
Time frame: between baseline and the end of spinal cord stimulation trial period (average of 1 month)
Population: Change in average EQ-5D scores from baseline is reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Activity and Sleep Quality Recording | Change in European Quality of Life 5 Dimensions (EQ-5D) | 0.23 change in score on a scale | Standard Deviation 0.12 |
Secondary
Change in European Quality of Life 5 Dimensions (EQ-5D)
Questionnaire pertaining to quality of life. Minimum Value 0, maximum value 1 with higher numbers representing higher quality of life
Time frame: between baseline and 3 month post permanent spinal cord stimulator activation followup
Population: Change in average EQ-5D scores from baseline is reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Activity and Sleep Quality Recording | Change in European Quality of Life 5 Dimensions (EQ-5D) | 0.18 change in score on a scale | Standard Deviation 0.19 |
Secondary
Change in Oswestry Disability Index (ODI)
Questionnaire pertaining to disability levels. Minimum value 0, maximum value 100 with higher values representing higher levels of disability.
Time frame: between baseline and the end of spinal cord stimulation trial period (average of 1 month)
Population: Percentage change in average ODI value from baseline is reported. One patient did not complete the ODI form correctly.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Activity and Sleep Quality Recording | Change in Oswestry Disability Index (ODI) | -18.6 change in score on a scale | Standard Error 15.8 |
Secondary
Change in Oswestry Disability Index (ODI)
Questionnaire pertaining to disability levels. Minimum value 0, maximum value 100 with higher values representing higher levels of disability.
Time frame: between baseline and 1 month post permanent spinal cord stimulator activation followup
Population: Change in average ODI value from baseline is reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Activity and Sleep Quality Recording | Change in Oswestry Disability Index (ODI) | -17.4 change in score on a scale | Standard Deviation 14.6 |
Secondary
Change in Oswestry Disability Index (ODI)
Questionnaire pertaining to disability levels. Minimum value 0, maximum value 100 with higher values representing higher levels of disability.
Time frame: between baseline and 2 month post permanent spinal cord stimulator activation followup
Population: Change in average ODI value from baseline is reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Activity and Sleep Quality Recording | Change in Oswestry Disability Index (ODI) | -18.8 change in score on a scale | Standard Deviation 14 |
Secondary
Change in Oswestry Disability Index (ODI)
Questionnaire pertaining to disability levels. Minimum value 0, maximum value 100 with higher values representing higher levels of disability.
Time frame: between baseline and 3 month post permanent spinal cord stimulator activation followup
Population: Change in average ODI value from baseline is reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Activity and Sleep Quality Recording | Change in Oswestry Disability Index (ODI) | -19.1 change in score on a scale | Standard Deviation 13.6 |
Secondary
Change in Sleep Quality
Recording performed with wrist worn accelerometer. Sleep duration was calculated based on accelerometry data.
Time frame: between baseline and 1 month post permanent spinal cord stimulator activation followup
Population: Change in average sleep duration from baseline value is reported. Activity recording files were not available for 1 patient
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Activity and Sleep Quality Recording | Change in Sleep Quality | 0.1 Change h/day from baseline value | Standard Deviation 0.82 |
Secondary
Change in Sleep Quality
Recording performed with wrist worn accelerometer. Sleep duration was calculated based on accelerometry data.
Time frame: between baseline and 2 month post permanent spinal cord stimulator activation followup
Population: Change in average sleep duration from baseline value is reported. Activity recording files were not available for 1 patient
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Activity and Sleep Quality Recording | Change in Sleep Quality | -0.06 Change h/day from baseline value | Standard Deviation 0.81 |
Secondary
Change in Sleep Quality
Recording performed with wrist worn accelerometer. Sleep duration was calculated based on accelerometry data.
Time frame: between baseline and 3 month post permanent spinal cord stimulator activation followup
Population: Percent change in average sleep duration from baseline value is reported. Activity files were not available for 5 patients
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Activity and Sleep Quality Recording | Change in Sleep Quality | 0 Change h/day from baseline value | Standard Deviation 0.61 |
Secondary
Change in Visual Analog Scale (VAS) for Pain
Subjective evaluation of pain levels used in clinical practice as standard. Minimum value is 0 (no pain), maximum value is 10 (maximum pain imaginable)
Time frame: between baseline and the end of spinal cord stimulation trial period (average of 1 month)
Population: Percentage change in average VAS value from baseline is reported (pain relief) Data was not available for 1 subject
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Activity and Sleep Quality Recording | Change in Visual Analog Scale (VAS) for Pain | -57.73 Percentage reduction from baseline score | Standard Error 31.4 |
Secondary
Change in Visual Analog Scale (VAS) for Pain
Subjective evaluation of pain levels used in clinical practice as standard. Minimum value is 0 (no pain), maximum value is 10 (maximum pain imaginable)
Time frame: between baseline and 1 month post permanent spinal cord stimulator activation followup
Population: Percentage reduction in average VAS value from baseline is reported (pain relief)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Activity and Sleep Quality Recording | Change in Visual Analog Scale (VAS) for Pain | -49.04 Percentage change from baseline score | Standard Error 47.49 |
Secondary
Change in Visual Analog Scale (VAS) for Pain
Subjective evaluation of pain levels used in clinical practice as standard. Minimum value is 0 (no pain), maximum value is 10 (maximum pain imaginable)
Time frame: between baseline and 2 month post permanent spinal cord stimulator activation followup
Population: Percentage change in average VAS value from baseline is reported (pain relief)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Activity and Sleep Quality Recording | Change in Visual Analog Scale (VAS) for Pain | -53.55 Percentage reduction from baseline score | Standard Deviation 43.81 |
Secondary
Change in Visual Analog Scale (VAS) for Pain
Subjective evaluation of pain levels used in clinical practice as standard. Minimum value is 0 (no pain), maximum value is 10 (maximum pain imaginable)
Time frame: between baseline and 3 month post permanent spinal cord stimulator activation followup
Population: Percentage change in average VAS value from baseline is reported (pain relief)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Activity and Sleep Quality Recording | Change in Visual Analog Scale (VAS) for Pain | 52.04 Percentage change from baseline score | Standard Deviation 44.95 |