Chronic Pain
Conditions
Brief summary
The goal of this interventional study is to test effects of spinal cord stimulation in patients receiving treatment for their chronic pain. The main question of the study is: • 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.
Interventions
DEVICEStimulation OFF
Stimulation is turned OFF
DEVICEStimulation ON
Stimulation is turned ON
DRUGTold ON
Verbal suggestion that stimulation is ON
DEVICETold OFF
Verbal suggestion that stimulation is OFF
Sponsors
University of Aarhus
Aarhus University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patients (\>18 years of age) with SCS implanted to treat chronic pain. * 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity, Visual Analogue Scale | Every 15 minutes during study session (max 4 hours) | 0-10 (0=no pain, 10=worst imaginable pain). Continual assessments to register changes. |
Countries
Denmark
Contacts
CONTACTLene Vase
CONTACTChristina Emborg, PhD
Outcome results
None listed