OASIS: Objective Assessment of Activity and Sleep Quality In Burst Spinal Cord Stimulation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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 |
Other: Accelerometry
Record of activity levels using a wrist worn accelerometer
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 Visual Analog Scale (VAS) for Pain [between baseline and 1 month post permanent spinal cord stimulator activation followup]
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 Visual Analog Scale (VAS) for Pain [between baseline and 2 month post permanent spinal cord stimulator activation followup]
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 Visual Analog Scale (VAS) for Pain [between baseline and 3 month post permanent spinal cord stimulator activation followup]
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 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.
- Change in European Quality of Life 5 Dimensions (EQ-5D) [between baseline and 1 month post permanent spinal cord stimulator activation followup]
Questionnaire pertaining to quality of life. Minimum Value 0, maximum value 1 with higher numbers representing higher quality of life
- Change in European Quality of Life 5 Dimensions (EQ-5D) [between baseline and 2 month post permanent spinal cord stimulator activation followup]
Questionnaire pertaining to quality of life. Minimum Value 0, maximum value 1 with higher numbers representing higher quality of life
- Change in European Quality of Life 5 Dimensions (EQ-5D) [between baseline and 3 month post permanent spinal cord stimulator activation followup]
Questionnaire pertaining to quality of life. Minimum Value 0, maximum value 1 with higher numbers representing higher quality of life
- 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 Oswestry Disability Index (ODI) [between baseline and 1 month post permanent spinal cord stimulator activation followup]
Questionnaire pertaining to disability levels. Minimum value 0, maximum value 100 with higher values representing higher levels of disability.
- Change in Oswestry Disability Index (ODI) [between baseline and 2 month post permanent spinal cord stimulator activation followup]
Questionnaire pertaining to disability levels. Minimum value 0, maximum value 100 with higher values representing higher levels of disability.
- Change in Oswestry Disability Index (ODI) [between baseline and 3 month post permanent spinal cord stimulator activation followup]
Questionnaire pertaining to disability levels. Minimum value 0, maximum value 100 with higher values representing higher levels of disability.
- 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 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 2 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 Sleep Quality [between baseline and 2 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 3 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 Sleep Quality [between baseline and 3 month post permanent spinal cord stimulator activation followup]
Recording performed with wrist worn accelerometer. Sleep duration was calculated based on accelerometry data.
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | AZ Sint-Augustinus | Wilrijk | Antwerp | Belgium | 2610 |
| 2 | AZ Middelheim | Antwerpen | Flanders | Belgium | 2020 |
| 3 | Erasmus MC | Rotterdam | South Holland | Netherlands | 3015 CE |
Sponsors and Collaborators
- Abbott Medical Devices
- AZ Sint-Augustinus, Wilrijk
- AZ Middelheim, Antwerpen
- Erasmus Medical Center
Investigators
- Study Director: Lalit Venkatesan, Ph.D., Abbott Medical Devices
Study Documents (Full-Text)
More Information
Publications
None provided.- SJM-CIP-10133
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Activity and Sleep Quality Recording |
|---|---|
| Arm/Group Description | 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 |
| Period Title: Overall Study | |
| STARTED | 27 |
| Complete Trial | 26 |
| Permanent Implant | 20 |
| 4 Week Follow up | 20 |
| 8 Weeks Follow up | 19 |
| COMPLETED | 18 |
| NOT COMPLETED | 9 |
Baseline Characteristics
| Arm/Group Title | Activity and Sleep Quality Recording |
|---|---|
| Arm/Group Description | 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 |
| Overall Participants | 27 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
23
85.2%
|
| >=65 years |
4
14.8%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
51.8
(11.3)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
19
70.4%
|
| Male |
8
29.6%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
0
0%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
27
100%
|
| Region of Enrollment (participants) [Number] | |
| Netherlands |
22
81.5%
|
| Belgium |
5
18.5%
|
Outcome Measures
| Title | Change in Activity Levels |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Average change in MVPA (h/day) from baseline value is reported. Activity recording files were not available for 2 patients. |
| Arm/Group Title | Activity and Sleep Quality Recording |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 24 |
| Mean (Standard Deviation) [change in MVPA h/day from baseline value] |
-0.17
(0.22)
|
| Title | Change in Sleep Quality |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change in average sleep duration from baseline value is reported. Activity recording files were not available for 2 patients. |
| Arm/Group Title | Activity and Sleep Quality Recording |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 24 |
| Mean (Standard Deviation) [Change h/day from baseline value] |
-0.05
(1.05)
|
| Title | Change in Visual Analog Scale (VAS) for Pain |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Percentage change in average VAS value from baseline is reported (pain relief) Data was not available for 1 subject |
| Arm/Group Title | Activity and Sleep Quality Recording |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 25 |
| Mean (Standard Error) [Percentage reduction from baseline score] |
-57.73
(31.4)
|
| Title | Change in Visual Analog Scale (VAS) for Pain |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Percentage reduction in average VAS value from baseline is reported (pain relief) |
| Arm/Group Title | Activity and Sleep Quality Recording |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 20 |
| Mean (Standard Error) [Percentage change from baseline score] |
-49.04
(47.49)
|
| Title | Change in Visual Analog Scale (VAS) for Pain |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Percentage change in average VAS value from baseline is reported (pain relief) |
| Arm/Group Title | Activity and Sleep Quality Recording |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 19 |
| Mean (Standard Deviation) [Percentage reduction from baseline score] |
-53.55
(43.81)
|
| Title | Change in Visual Analog Scale (VAS) for Pain |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Percentage change in average VAS value from baseline is reported (pain relief) |
| Arm/Group Title | Activity and Sleep Quality Recording |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 18 |
| Mean (Standard Deviation) [Percentage change from baseline score] |
52.04
(44.95)
|
| Title | Change in European Quality of Life 5 Dimensions (EQ-5D) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change in average EQ-5D scores from baseline is reported |
| Arm/Group Title | Activity and Sleep Quality Recording |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 26 |
| Mean (Standard Deviation) [change in score on a scale] |
0.23
(0.12)
|
| Title | Change in European Quality of Life 5 Dimensions (EQ-5D) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change in average EQ-5D scores from baseline is reported |
| Arm/Group Title | Activity and Sleep Quality Recording |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 20 |
| Mean (Standard Deviation) [change in score on a scale] |
0.19
(0.17)
|
| Title | Change in European Quality of Life 5 Dimensions (EQ-5D) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change in average EQ-5D scores from baseline is reported |
| Arm/Group Title | Activity and Sleep Quality Recording |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 19 |
| Mean (Standard Deviation) [change in score on a scale] |
0.23
(0.14)
|
| Title | Change in European Quality of Life 5 Dimensions (EQ-5D) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change in average EQ-5D scores from baseline is reported |
| Arm/Group Title | Activity and Sleep Quality Recording |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 18 |
| Mean (Standard Deviation) [change in score on a scale] |
0.18
(0.19)
|
| Title | Change in Oswestry Disability Index (ODI) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Percentage change in average ODI value from baseline is reported. One patient did not complete the ODI form correctly. |
| Arm/Group Title | Activity and Sleep Quality Recording |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 25 |
| Mean (Standard Error) [change in score on a scale] |
-18.6
(15.8)
|
| Title | Change in Oswestry Disability Index (ODI) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change in average ODI value from baseline is reported. |
| Arm/Group Title | Activity and Sleep Quality Recording |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 20 |
| Mean (Standard Deviation) [change in score on a scale] |
-17.4
(14.6)
|
| Title | Change in Oswestry Disability Index (ODI) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change in average ODI value from baseline is reported. |
| Arm/Group Title | Activity and Sleep Quality Recording |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 19 |
| Mean (Standard Deviation) [change in score on a scale] |
-18.8
(14.0)
|
| Title | Change in Oswestry Disability Index (ODI) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change in average ODI value from baseline is reported. |
| Arm/Group Title | Activity and Sleep Quality Recording |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 18 |
| Mean (Standard Deviation) [change in score on a scale] |
-19.1
(13.6)
|
| Title | Change in Activity Levels |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Average change in MVPA (h/day) from baseline value is reported. Activity recording files were not available for 1 patient |
| Arm/Group Title | Activity and Sleep Quality Recording |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 19 |
| Mean (Standard Deviation) [change in MVPA h/day from baseline value] |
-0.01
(0.09)
|
| Title | Change in Sleep Quality |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change in average sleep duration from baseline value is reported. Activity recording files were not available for 1 patient |
| Arm/Group Title | Activity and Sleep Quality Recording |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 19 |
| Mean (Standard Deviation) [Change h/day from baseline value] |
0.1
(0.82)
|
| Title | Change in Activity Levels |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Average change in MVPA (h/day) from baseline value is reported. Activity recording files were not available for 1 patient |
| Arm/Group Title | Activity and Sleep Quality Recording |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 18 |
| Mean (Standard Deviation) [change in MVPA h/day from baseline value] |
0.03
(0.08)
|
| Title | Change in Sleep Quality |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change in average sleep duration from baseline value is reported. Activity recording files were not available for 1 patient |
| Arm/Group Title | Activity and Sleep Quality Recording |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 18 |
| Mean (Standard Deviation) [Change h/day from baseline value] |
-0.06
(0.81)
|
| Title | Change in Activity Levels |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Average change in MVPA (h/day) from baseline value is reported. Activity files were not available for 5 patients |
| Arm/Group Title | Activity and Sleep Quality Recording |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 13 |
| Mean (Standard Deviation) [change in MVPA h/day from baseline value] |
0.02
(0.08)
|
| Title | Change in Sleep Quality |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Percent change in average sleep duration from baseline value is reported. Activity files were not available for 5 patients |
| Arm/Group Title | Activity and Sleep Quality Recording |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 13 |
| Mean (Standard Deviation) [Change h/day from baseline value] |
0
(0.61)
|
Adverse Events
| Time Frame | From baseline to 3rd month follow up for an average duration of 4.6 months (including trial and wait time between trial and permanent implant) | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Activity and Sleep Quality Recording | |
| Arm/Group Description | 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 | |
All Cause Mortality |
||
| Activity and Sleep Quality Recording | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/27 (0%) | |
Serious Adverse Events |
||
| Activity and Sleep Quality Recording | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/27 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Activity and Sleep Quality Recording | ||
| Affected / at Risk (%) | # Events | |
| Total | 3/27 (11.1%) | |
| General disorders | ||
| IPG pocket pain | 1/27 (3.7%) | 1 |
| Nervous system disorders | ||
| Increased pain/inadequate pain relief that required device reprogramming | 2/27 (7.4%) | 4 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Filippo Agnesi |
|---|---|
| Organization | St. Jude Medical |
| Phone | 14694184987 |
| filippo.agnesi@abbott.com |
- SJM-CIP-10133