Failed Back Surgery SyndromeNCT04710355
Objective Data on Daily Activity in Patients Treated with SCS: the Intellis Study
An observational study of Failed Back Surgery Syndrome, run by Sahlgrenska University Hospital at 7 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Failed Back Surgery Syndrome
- What is being tested?
- Spinal cord stimulation
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 1 Aug 2020to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Refractory chronic pain in low-back and/or legs that persists for at least 6 months following the most recent spinal surgery
- 18-70 years of age. Patients >70 years will not be included due to the reduction in general activity level that is usually seen in older patient cohorts.
- Mean pain intensity should be 5 or higher measured on a Visual Analogue Scale (VAS).
- Patient has been informed of the study procedures and has given written informed consent.
Who cannot join
- Expected inability of patients to receive or properly operate the spinal cord stimulation system
- History of coagulation disorders, lupus erythematosus, rheumatoid arthritis
- Addiction to drugs, alcohol (5E/day) and/or medication
- Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator
- Active malignancy
- Life expectancy < 1 year
- Local infection or other skin disorder at site of incision
- Pregnancy
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Netherlands4 sites
Rijnstate Hospital
Arnhem
MCL Leeuwarden
Leeuwarden
Bravis Hospital
Roosendaal
Diakonissenhuis Hospital
Zeist
About this study
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
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.
Read the 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 and/or leg(s) 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:
- Utilize an existing neurostimulator-based data diary to measure gross daily activity in patients with chronic pain
- Test the usefulness of this data diary as a tool for objective evaluation of SCS efficacy on chronic pain.
- Investigate how the collected objective data relates to the subjective experience of the patient when evaluating the effects of SCS.
Materials/Methods:
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 subject's 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 (FBSS).1 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 sensors.2.3 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 FBSS.4 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 upright/upright 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
- Utilize an existing neurostimulator-based data diary to measure gross daily activity in patients with CBLP.
- Test the usefulness of this data diary as a tool for objective evaluation of SCS efficacy on CBLP.
- Investigate how the collected objective data relates to the subjective experience of the patient when evaluating the effects of SCS.
- Conditions
- Failed Back Surgery Syndrome
- Being tested
- Spinal cord stimulation
- Medical subject headings
- Failed Back Surgery Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal cord stimulationDevice
Adhesion of Intellis spinal cord stimulator to the skin of the abdomen for 4 weeks for baseline recording of activity level prior to trial with spinal cord stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Chronic pain | Failed back surgery syndrome Receives: Device: Spinal cord stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Position reporting: Intellis SnapShot Reporting
The Intellis neurostimulator provides reports (extracted with the physician programmer) on the position of the patient over a certain time-period. The built-in software provides summary reports over periods of weeks.
Measured: Change from baseline Intellis SnapShot Reporting at 12 months
Secondary outcomes (4)
Pain: Visual Analogue Scale (VAS)
The VAS questionnaire is a standardized instrument that tries to measure the amount of pain that a patient feels across a continuum from none to an extreme amount of pain. Operationally a VAS is a horizontal line, 100 mm in length, anchored by word descriptors at each end. A score of 0 (zero) is "no pain" while a score of 10 (ten) is "worst possible pain". The patient marks on the line the point that they feel represents their perception of their current state.
Measured: Change from baseline VAS at 12 months
Health Related Quality of Life: EuroQoL Group - 5 Dimensional (EQ-5D)
The EuroQoL EQ-5D is a generic measure of self-rated health status, where health is characterized on five dimensions: mobility, self-care, ability to undertake usual activities, pain and anxiety/ depression. Patients are asked to indicate their level of health on each dimension using one of three levels: "no health problems", "moderate health problems", and "severe health problems". Designed for self-completion, this scale provides a simple descriptive profile and a single index value for health status.
Measured: Change from baseline EQ-5D at 12 months
Disability: Oswestry Disability Index (ODI)
ODI is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Measured: Change from baseline ODI at 12 months
Sleep: Pain and Sleep Questionnaire eight item index (PSQ-8)
The Pain and Sleep Questionnaire (PSQI) is a self-report questionnaire that assesses the impact of pain on sleep in patients with chronic non-malignant pain of various etiologies The measure consists of 8 individual items that produce one global score.
Measured: Change from baseline PSQI at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start1 Aug 2020
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Failed Back Surgery SyndromeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kliment Gatzinsky, Vastra Gotaland Region
- Investigators
- Kliment Gatzinsky, MD, PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710355
- Sponsor's protocol ID
- Dnr 2020-00785
- Status last verified
- Jan 2025
- First submitted
- 12 Jan 2021
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hallen T, Meier K, Kallewaard JW, Billet B, Elzinga L, Schapendonk J, Van den Bosch E, Zuidema X, Eygloardottir KL, Gulisano H, Gatzinsky K. Objective, long-term mobility data in patients with chronic pain after lumbar spine surgery treated with spinal cord stimulation-a prospective, multicenter trial. Reg Anesth Pain Med. 2025 Jul 10:rapm-2025-106726. doi: 10.1136/rapm-2025-106726. Online ahead of print.
PubMed 40639954
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04710355
- Acronym / sponsor ID
- Dnr 2020-00785
- Conditions
- Failed Back Surgery Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 14 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 and/or leg(s) 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:
- Utilize an existing neurostimulator-based data diary to measure gross daily activity in patients with chronic pain
- Test the usefulness of this data diary as a tool for objective evaluation of SCS efficacy on chronic pain.
- Investigate how the collected objective data relates to the subjective experience of the patient when evaluating the effects of SCS.
Materials/Methods:
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 subject's 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 (FBSS).1 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 sensors.2.3 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 FBSS.4 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 upright/upright 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
- Utilize an existing neurostimulator-based data diary to measure gross daily activity in patients with CBLP.
- Test the usefulness of this data diary as a tool for objective evaluation of SCS efficacy on CBLP.
- Investigate how the collected objective data relates to the subjective experience of the patient when evaluating the effects of SCS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic pain | – | Device: Spinal cord stimulationFailed back surgery syndrome |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Refractory chronic pain in low-back and/or legs that persists for at least 6 months following the most recent spinal surgery
- 18-70 years of age. Patients >70 years will not be included due to the reduction in general activity level that is usually seen in older patient cohorts.
- Mean pain intensity should be 5 or higher measured on a Visual Analogue Scale (VAS).
- Patient has been informed of the study procedures and has given written informed consent.
Key exclusion criteria (8 listed)
- Expected inability of patients to receive or properly operate the spinal cord stimulation system
- History of coagulation disorders, lupus erythematosus, rheumatoid arthritis
- Addiction to drugs, alcohol (5E/day) and/or medication
- Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator
- Active malignancy
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 |
|---|---|---|
| Spinal cord stimulationAdhesion of Intellis spinal cord stimulator to the skin of the abdomen for 4 weeks for baseline recording of activity level prior to trial with spinal cord stimulation. | Device | Chronic pain |
Primary outcome
Position reporting: Intellis SnapShot Reporting
Time frame: Change from baseline Intellis SnapShot Reporting at 12 months
The Intellis neurostimulator provides reports (extracted with the physician programmer) on the position of the patient over a certain time-period. The built-in software provides summary reports over periods of weeks.
4 secondary outcomes
Pain: Visual Analogue Scale (VAS)
Time frame: Change from baseline VAS at 12 months
Health Related Quality of Life: EuroQoL Group - 5 Dimensional (EQ-5D)
Time frame: Change from baseline EQ-5D at 12 months
Disability: Oswestry Disability Index (ODI)
Time frame: Change from baseline ODI at 12 months
Sleep: Pain and Sleep Questionnaire eight item index (PSQ-8)
Time frame: Change from baseline PSQI at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Derived from this study: PubMed 40639954Hallen T, Meier K, Kallewaard JW, Billet B, Elzinga L, Schapendonk J, Van den Bosch E, Zuidema X, Eygloardottir KL, Gulisano H, Gatzinsky K. Objective, long-term mobility data in patients with chronic pain after lumbar spine surgery treated with spinal cord stimulation-a prospective, multicenter trial. Reg Anesth Pain Med. 2025 Jul 10:rapm-2025-106726. doi: 10.1136/rapm-2025-106726. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Failed Back Surgery Syndrome
RecruitingObservational study
Open and Closed Loop DTM SCS in Patients With PSPS Type 2: ENDLESS Study
Persistent Spinal Pain Syndrome Type 2, Failed Back Surgery Syndrome
RecruitingPhase 4
Success Rates and Safety of Steroid Injections in Managing Spinal and Sacro-Iliac Pain (CORTisone Injection Spine Study)
Back Pain Lower Back, Neck Pain
Not yet recruitingObservational study
SPINE-RISK VE: Multimodal Predictive Model for Failed Back Surgery Syndrome in Venezuelan Surgical Patients
Persistent Spinal Pain Syndrome Type 2 (PSPS-T) Lower Spine, Chronic Low Back Pain
Active, not recruiting
Restoring Segmental Lumbar Lordosis After Failed Previous Fusion at the Same Level
Failed Back Surgery Syndrome, Degeneration Lumbar Spine
Recruiting
Improvement of Gait by Spinal Stimulation in Patients With Postoperative Chronic Lumbosciatalgia: Pilot Study (GaitStim)
Failed Back Surgery Syndrome
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.
Kliment Gatzinsky, MD, PhD principal investigator
Sahlgrenska University Hospital
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Failed Back Surgery Syndrome, run by Sahlgrenska University Hospital at 7 sites in 4 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 4 inclusion and 8 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 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Netherlands, Belgium, Denmark, Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Position reporting: Intellis SnapShot Reporting (time frame: Change from baseline Intellis SnapShot Reporting at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04710355, which also lists 1 linked publication.
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 16 Jan 2025.