Objective Data on Daily Activity in Patients Treated With SCS: the Intellis Study
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|ClinicalTrials.gov Identifier: NCT04710355|
Recruitment Status : Recruiting
First Posted : January 14, 2021
Last Update Posted : January 14, 2021
|Condition or disease||Intervention/treatment|
|Failed Back Surgery Syndrome||Device: Spinal cord stimulation|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|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|
|Actual Study Start Date :||August 1, 2020|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Failed back surgery syndrome
Device: Spinal cord stimulation
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.
- 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.
- Pain: Visual Analogue Scale (VAS) [ Time Frame: Change from baseline VAS at 12 months ]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.
- Health Related Quality of Life: EuroQoL Group - 5 Dimensional (EQ-5D) [ Time Frame: Change from baseline EQ-5D at 12 months ]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.
- Disability: Oswestry Disability Index (ODI) [ Time Frame: Change from baseline ODI at 12 months ]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.
- Sleep: Pain and Sleep Questionnaire eight item index (PSQ-8) [ Time Frame: Change from baseline PSQI at 12 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04710355
|Contact: Kliment Gatzinsky, MD, PhDemail@example.com|
|Contact: Kaare Meier, MD, PhDfirstname.lastname@example.org|
|AZ Delta Hospital||Not yet recruiting|
|Contact: Bart Billet|
|Aalborg University Hospital||Not yet recruiting|
|Contact: Helga Gulisano|
|Contact: Jan Willem Kallewaard|
|Contact: Eric van den Bosch|
|Contact: Lars Elzinga|
|Diakonissenhuis Hospital||Active, not recruiting|
|Sahlgrenska University Hospital||Recruiting|
|Contact: Kliment Gatzinsky|
|Principal Investigator:||Kliment Gatzinsky, MD, PhD||Sahlgrenska University Hospital, Sweden|