Ignite Creation Date:
2024-05-06 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04710355
Status:
COMPLETED
Last Update Posted:
2023-03-23
First Post:
2021-01-12
Brief Title:
Objective Data on Daily Activity in Patients Treated With SCS the Intellis Study
Sponsor:
Sahlgrenska University Hospital Sweden
Organization:
Sahlgrenska University Hospital Sweden
Study Overview
Official Title:
Objective Long-term Data Recording of Daily Activity in Patients With Failed Back Surgery Syndrome Treated With Spinal Cord Stimulation - a Prospective 12-month Follow-up Study
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In spinal cord stimulation SCS most outcome data are based on patient questionnaires The lack of tools for objective evaluation of the effects of SCS on chronic pain has posed a barrier for providing solid proof of the therapy Currently however SCS-devices with an accelerator included are available on the market The position orientation data provided by the neurostimulator therefore gives new possibilities for objective measurement of gross activity in daily life
Detailed Description:
Although the interaction between chronic pain and physical functioning is a well-accepted paradigm objective data on how pain affects individuals daily life is scanty Most data are based on patient questionnaires The purpose of this study is to objectively assess the activity of daily living in chronic pain patients treated with spinal cord stimulation SCS
Indication Chronic pain in the low-back andor legs due to failed back surgery syndrome
Study Design Prospective open-label multi-center observational study
Sample Size 50 patients receiving an Intellis neurostimulator for treatment with SCS
Study Centers Up to 10 sites in Europe
Objectives
1 Utilize an existing neurostimulator-based data diary to measure gross daily activity in patients with chronic pain
2 Test the usefulness of this data diary as a tool for objective evaluation of SCS efficacy on chronic pain
3 Investigate how the collected objective data relates to the subjective experience of the patient when evaluating the effects of SCS
MaterialsMethods
Patients diagnosed with failed back surgery syndrome FBSS with chronic back and leg pain that have been evaluated as candidates for SCS will be included
Gross daily activity is recorded using the Intellis neurostimulator Medtronic Inc which contains a diary AdaptiveStim Diary that continuously stores data of seven different body positions upright upright mobile recline and 4 lying positions Recordings are performed for 4 weeks before the SCS trial baseline using an external Intellis device adhered to the skin of the abdomen and thereafter in patients who responded to SCS during the SCS-trial period utilizing the permanent Intellis implanted subcutaneously at the same site Data will be extracted from the data diary at 3 6 and 12 months after implantation of the SCS system and compared with changes in pain quality of life and sleep as assessed by patient self-report questionnaires using validated tools
Study Duration
The estimated duration of the study from first enrolment to final report is 24 months including a 10 months enrolment period The estimated duration of a subjects participation in the study is approximately 12 months Interim analyses will be performed after 3 and 6 months follow up
BACKGROUND The use of spinal cord stimulation SCS for pain control has already a history of more than 50 years During the last decades many articles have been published indicating the effectiveness and safety of SCS in the pain management of chronic neuropathic pain and in particular in patients with chronic back and leg pain due to persisting new or recurrent pain after spinal surgery so called failed back surgery syndrome FBSS1 In this patient group the interaction between chronic pain and physical functioning is a well-accepted paradigm although objective data that shows how pain affects individuals daily life is scanty Correlation between reduction in pain intensity and sustained improvement in physical activity has previously been demonstrated using kinematical sensors23 In SCS most outcome data are based on patient questionnaires The lack of tools for objective evaluation of the effects of SCS on chronic pain has posed a barrier for providing solid proof of the therapy Currently however SCS-devices with an accelerator included are available on the market The position orientation data provided by the neurostimulator therefore gives new possibilities for objective measurement of gross activity in daily life
In an earlier single center pilot study with the first implantable neurostimulator with an accelerometer the potential of objective outcome measurements was explored in six patients with FBSS4 A positive correlation between decrease in pain and increase in time spent in upright position has been demonstrated by the preliminary pilot study utilizing this neurostimulator in which position and uprightupright mobile changes were recorded based on 24-hour cycles However not all patients that experience good pain relief showed an increased activity level depending on which position that is painful
With the new neurostimulator Intellis position changes and level of activity are recorded on an hour by hour basis which makes it possible to differentiate between day and night activity The goal of the current study is to repeat the pilot study on objective outcomes with the newly available neurostimulator with inbuilt accelerometer using a prospective open-label observational study design
OBJECTIVES
1 Utilize an existing neurostimulator-based data diary to measure gross daily activity in patients with CBLP
2 Test the usefulness of this data diary as a tool for objective evaluation of SCS efficacy on CBLP
3 Investigate how the collected objective data relates to the subjective experience of the patient when evaluating the effects of SCS
Indication Chronic pain in the low-back andor legs due to failed back surgery syndrome
Study Design Prospective open-label multi-center observational study
Sample Size 50 patients receiving an Intellis neurostimulator for treatment with SCS
Study Centers Up to 10 sites in Europe
Objectives
1 Utilize an existing neurostimulator-based data diary to measure gross daily activity in patients with chronic pain
2 Test the usefulness of this data diary as a tool for objective evaluation of SCS efficacy on chronic pain
3 Investigate how the collected objective data relates to the subjective experience of the patient when evaluating the effects of SCS
MaterialsMethods
Patients diagnosed with failed back surgery syndrome FBSS with chronic back and leg pain that have been evaluated as candidates for SCS will be included
Gross daily activity is recorded using the Intellis neurostimulator Medtronic Inc which contains a diary AdaptiveStim Diary that continuously stores data of seven different body positions upright upright mobile recline and 4 lying positions Recordings are performed for 4 weeks before the SCS trial baseline using an external Intellis device adhered to the skin of the abdomen and thereafter in patients who responded to SCS during the SCS-trial period utilizing the permanent Intellis implanted subcutaneously at the same site Data will be extracted from the data diary at 3 6 and 12 months after implantation of the SCS system and compared with changes in pain quality of life and sleep as assessed by patient self-report questionnaires using validated tools
Study Duration
The estimated duration of the study from first enrolment to final report is 24 months including a 10 months enrolment period The estimated duration of a subjects participation in the study is approximately 12 months Interim analyses will be performed after 3 and 6 months follow up
BACKGROUND The use of spinal cord stimulation SCS for pain control has already a history of more than 50 years During the last decades many articles have been published indicating the effectiveness and safety of SCS in the pain management of chronic neuropathic pain and in particular in patients with chronic back and leg pain due to persisting new or recurrent pain after spinal surgery so called failed back surgery syndrome FBSS1 In this patient group the interaction between chronic pain and physical functioning is a well-accepted paradigm although objective data that shows how pain affects individuals daily life is scanty Correlation between reduction in pain intensity and sustained improvement in physical activity has previously been demonstrated using kinematical sensors23 In SCS most outcome data are based on patient questionnaires The lack of tools for objective evaluation of the effects of SCS on chronic pain has posed a barrier for providing solid proof of the therapy Currently however SCS-devices with an accelerator included are available on the market The position orientation data provided by the neurostimulator therefore gives new possibilities for objective measurement of gross activity in daily life
In an earlier single center pilot study with the first implantable neurostimulator with an accelerometer the potential of objective outcome measurements was explored in six patients with FBSS4 A positive correlation between decrease in pain and increase in time spent in upright position has been demonstrated by the preliminary pilot study utilizing this neurostimulator in which position and uprightupright mobile changes were recorded based on 24-hour cycles However not all patients that experience good pain relief showed an increased activity level depending on which position that is painful
With the new neurostimulator Intellis position changes and level of activity are recorded on an hour by hour basis which makes it possible to differentiate between day and night activity The goal of the current study is to repeat the pilot study on objective outcomes with the newly available neurostimulator with inbuilt accelerometer using a prospective open-label observational study design
OBJECTIVES
1 Utilize an existing neurostimulator-based data diary to measure gross daily activity in patients with CBLP
2 Test the usefulness of this data diary as a tool for objective evaluation of SCS efficacy on CBLP
3 Investigate how the collected objective data relates to the subjective experience of the patient when evaluating the effects of SCS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None