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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
Sponsor:
Information provided by (Responsible Party):
Kliment Gatzinsky, Sahlgrenska University Hospital, Sweden

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.

Condition or disease Intervention/treatment
Failed Back Surgery Syndrome Device: Spinal cord stimulation

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
Chronic pain
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Kliment Gatzinsky, MD, PhD +46733407733 kliment.gatzinsky@neuro.gu.se
Contact: Kaare Meier, MD, PhD kaare@kaare.org

Locations
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Belgium
AZ Delta Hospital Not yet recruiting
Roeselare, Belgium
Contact: Bart Billet         
Denmark
Aalborg University Hospital Not yet recruiting
Aalborg, Denmark
Contact: Helga Gulisano         
Netherlands
Rijnstate Hospital Recruiting
Arnhem, Netherlands
Contact: Jan Willem Kallewaard         
MCL Leeuwarden Recruiting
Leeuwarden, Netherlands
Contact: Eric van den Bosch         
Bravis Hospital Recruiting
Roosendaal, Netherlands
Contact: Lars Elzinga         
Diakonissenhuis Hospital Active, not recruiting
Zeist, Netherlands
Sweden
Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden
Contact: Kliment Gatzinsky         
Sponsors and Collaborators
Kliment Gatzinsky
Investigators
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Principal Investigator: Kliment Gatzinsky, MD, PhD Sahlgrenska University Hospital, Sweden
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Responsible Party: Kliment Gatzinsky, MD, PhD, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT04710355    
Other Study ID Numbers: Dnr 2020-00785
First Posted: January 14, 2021    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Syndrome
Failed Back Surgery Syndrome
Disease
Pathologic Processes
Postoperative Complications
Back Pain
Pain
Neurologic Manifestations