Chronic PainOASISNCT02950831
Objective Assessment of Activity and Sleep Quality In Burst Spinal Cord Stimulation
A study testing Accelerometry in people with Chronic Pain, run by Abbott Medical Devices at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Accelerometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Oct 2016to Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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;
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- 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)
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Belgium2 sites
AZ Middelheim
Antwerp, Flanders, 2020
AZ Sint-Augustinus
Wilrijk, Antwerp, 2610
About this study
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Accelerometry
- Keywords
- Chronic Pain, BurstDR, spinal cord stimulation, Accelerometry
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccelerometryOther
Also called wrist worn accelerometers
Record of activity levels using a wrist worn accelerometer
| Study group | Role | What they receive |
|---|---|---|
| Activity and sleep quality recording | Experimental | 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 Receives: Other: Accelerometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: between baseline and the end of spinal cord stimulation trial period (average of 1 month)
Change in Sleep Quality
Recording performed with wrist worn accelerometer. Sleep duration was calculated based on accelerometry data.
Measured: between baseline and the end of spinal cord stimulation trial period (average of 1 month)
Secondary outcomes (18)
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)
Measured: between baseline and the end of spinal cord stimulation trial period (average of 1 month)
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)
Measured: between baseline and 1 month post permanent spinal cord stimulator activation followup
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)
Measured: between baseline and 2 month post permanent spinal cord stimulator activation followup
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)
Measured: between baseline and 3 month post permanent spinal cord stimulator activation followup
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.
Measured: between baseline and the end of spinal cord stimulation trial period (average of 1 month)
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
Measured: between baseline and 1 month post permanent spinal cord stimulator activation followup
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
Measured: between baseline and 2 month post permanent spinal cord stimulator activation followup
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
Measured: between baseline and 3 month post permanent spinal cord stimulator activation followup
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.
Measured: between baseline and the end of spinal cord stimulation trial period (average of 1 month)
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.
Measured: between baseline and 1 month post permanent spinal cord stimulator activation followup
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.
Measured: between baseline and 2 month post permanent spinal cord stimulator activation followup
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.
Measured: between baseline and 3 month post permanent spinal cord stimulator activation followup
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.
Measured: between baseline and 1 month post permanent spinal cord stimulator activation followup
Change in Sleep Quality
Recording performed with wrist worn accelerometer. Sleep duration was calculated based on accelerometry data.
Measured: between baseline and 1 month post permanent spinal cord stimulator activation followup
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.
Measured: between baseline and 2 month post permanent spinal cord stimulator activation followup
Change in Sleep Quality
Recording performed with wrist worn accelerometer. Sleep duration was calculated based on accelerometry data.
Measured: between baseline and 2 month post permanent spinal cord stimulator activation followup
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.
Measured: between baseline and 3 month post permanent spinal cord stimulator activation followup
Change in Sleep Quality
Recording performed with wrist worn accelerometer. Sleep duration was calculated based on accelerometry data.
Measured: between baseline and 3 month post permanent spinal cord stimulator activation followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AZ Sint-Augustinus, Wilrijk, AZ Middelheim, Antwerpen, Erasmus Medical Center
- Responsible party
- Sponsor
- Investigators
- Lalit Venkatesan, Ph.D., Study director, Abbott Medical Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950831
- Sponsor's protocol ID
- SJM-CIP-10133
- Acronym
- OASIS
- Status last verified
- Jul 2019
- First submitted
- 27 Oct 2016
- Last updated
- 29 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Assessment of Activity and Sleep Quality In Burst Spinal Cord Stimulation
- ClinicalTrials.gov ID
- NCT02950831
- Acronym / sponsor ID
- OASIS / SJM-CIP-10133
- Conditions
- Chronic Pain
- Keywords
- Chronic Pain, BurstDR, spinal cord stimulation, Accelerometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Collaborators
- AZ Sint-Augustinus, Wilrijk, AZ Middelheim, Antwerpen, Erasmus Medical Center
- Study start
- Oct 2016
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Posted 29 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Activity and sleep quality recording | Experimental | Other: AccelerometryPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AccelerometryAlso: wrist worn accelerometersRecord of activity levels using a wrist worn accelerometer | Other | Activity and sleep quality recording |
Primary outcome
Change in Activity Levels
Time frame: 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
Time frame: 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.
18 secondary outcomes
Change in Visual Analog Scale (VAS) for Pain
Time frame: between baseline and the end of spinal cord stimulation trial period (average of 1 month)
Change in Visual Analog Scale (VAS) for Pain
Time frame: between baseline and 1 month post permanent spinal cord stimulator activation followup
Change in Visual Analog Scale (VAS) for Pain
Time frame: between baseline and 2 month post permanent spinal cord stimulator activation followup
Change in Visual Analog Scale (VAS) for Pain
Time frame: between baseline and 3 month post permanent spinal cord stimulator activation followup
Change in European Quality of Life 5 Dimensions (EQ-5D)
Time frame: between baseline and the end of spinal cord stimulation trial period (average of 1 month)
Change in European Quality of Life 5 Dimensions (EQ-5D)
Time frame: between baseline and 1 month post permanent spinal cord stimulator activation followup
Change in European Quality of Life 5 Dimensions (EQ-5D)
Time frame: between baseline and 2 month post permanent spinal cord stimulator activation followup
Change in European Quality of Life 5 Dimensions (EQ-5D)
Time frame: between baseline and 3 month post permanent spinal cord stimulator activation followup
Change in Oswestry Disability Index (ODI)
Time frame: between baseline and the end of spinal cord stimulation trial period (average of 1 month)
Change in Oswestry Disability Index (ODI)
Time frame: between baseline and 1 month post permanent spinal cord stimulator activation followup
Change in Oswestry Disability Index (ODI)
Time frame: between baseline and 2 month post permanent spinal cord stimulator activation followup
Change in Oswestry Disability Index (ODI)
Time frame: between baseline and 3 month post permanent spinal cord stimulator activation followup
Change in Activity Levels
Time frame: between baseline and 1 month post permanent spinal cord stimulator activation followup
Change in Sleep Quality
Time frame: between baseline and 1 month post permanent spinal cord stimulator activation followup
Change in Activity Levels
Time frame: between baseline and 2 month post permanent spinal cord stimulator activation followup
Change in Sleep Quality
Time frame: between baseline and 2 month post permanent spinal cord stimulator activation followup
Change in Activity Levels
Time frame: between baseline and 3 month post permanent spinal cord stimulator activation followup
Change in Sleep Quality
Time frame: between baseline and 3 month post permanent spinal cord stimulator activation followup
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lalit Venkatesan, Ph.D. study director
Abbott Medical Devices
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerometry in people with Chronic Pain, run by Abbott Medical Devices at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Activity Levels (time frame: between baseline and the end of spinal cord stimulation trial period (average of 1 month)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2019.