Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
25 participants
INTERVENTIONAL
2023-05-01
2028-12-31
Brief Summary
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• What is the effect of spinal cord stimulation when compared to placebo? Participants will rate their pain with their usual spinal cord stimulation on and off.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Spinal cord stimulation turned on
Spinal cord stimulation turned on (suggestions: off)
Spinal cord stimulation turned on with verbal suggestions of treatment off
Spinal cord stimulation turned off
Spinal cord stimulation turned off (suggestions: on)
Spinal cord stimulation turned off with verbal suggestions of treatment on
Spinal cord stimulation turned on and suggestions
Spinal cord stimulation turned on with suggestions (suggestions on)
Spinal cord stimulation turned on with verbal suggestions of treatment on
Control
No interventions assigned to this group
Interventions
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Spinal cord stimulation turned on (suggestions: off)
Spinal cord stimulation turned on with verbal suggestions of treatment off
Spinal cord stimulation turned off (suggestions: on)
Spinal cord stimulation turned off with verbal suggestions of treatment on
Spinal cord stimulation turned on with suggestions (suggestions on)
Spinal cord stimulation turned on with verbal suggestions of treatment on
Eligibility Criteria
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Inclusion Criteria
* Patients who consent to participation and can cooperate in the study.
* Use of continuous paresthesia-free SCS for minimum 6 months prior to participation in the study.
* Pain score of 7 or less on a 0-10 scale in the most painful area treated with SCS, rated upon inclusion.
* Patients not receiving other neuromodulation treatment.
* Patients who have not undergone changes in their (pain relevant) medication during the last 30 days (pro necessitate medication allowed).
18 Years
99 Years
ALL
No
Sponsors
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Aarhus University Hospital
OTHER
University of Aarhus
OTHER
Responsible Party
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Locations
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Department of Neurosurgery, Aarhus University Hospital
Aarhus, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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UAarhus_SCS
Identifier Type: -
Identifier Source: org_study_id
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