Spinal Cord Stimulation
Conditions
Keywords
Spinal Cord Stimulation, Chronic pain
Brief summary
The aim of the study is to evaluate treatment outcomes of Spinal Cord Stimulation. In the study each patient participates in four test sessions of 4-5 hours. Patients arrive for test days with their stimulation on. In each test session, baseline pain is first evaluated. Then, SCS is regulated (on/off) and patients evaluate their pain intensity immidiately and every 15 minutes during the test sessions. Patients are blinded to the treatment conditions during their participation in the study. At all times, patients can resume their usual treatment.
Interventions
DEVICEStimulation ON
Stimulator will be turned on
DEVICEStimulation OFF
Stimulation is turned off
DEVICETold ON
Verbal suggestion that stimulation is on
DEVICETold OFF
Verbal suggestion that stimulation is off
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 |
|---|---|
| Patients' subjective pain intensity evaluated on a 0-10 Mechanical Visual Analogue Scale (M-VAS) | From enrollment to completion of four test sessions scheduled with a minimum interval of one week between each session. |
Countries
Denmark
Outcome results
None listed