Project overview
In this prospective, multicenter cohort study, the aim is to evaluate the effectiveness of differential target multiplexed spinal cord stimulation for the treatment of chronic back/neck and leg/arm pain. Identification of clinical effective parameters concerning frequency, pulse duration, amplitude and battery consumption/recharge frequency and safety evaluation will also be performed. In total, 200 patients with Persistent Spinal Pain Syndrome Type II will be included in several European countries.
The study is registered at ClinicalTrials.gov under number NCT07211308.
Criteria
Criteria for evaluation: Effectiveness
Primary effectiveness endpoint
Current pain intensity measured with the Visual Analogue Scale (VAS) through ecological momentary assessment.
Secondary effectiveness endpoints
- Average pain intensity without medication and with medication
- Negative affect
- Disability
- Actigraphy
- Medication use
- Health-related quality of life
- Patient global impression of change
- Clinical holistic responder status
- Pain catastrophizing
- Patient unwanted stimulation awareness
- Anxiety and Depression
- Work status
- Time spent in seven body postures
Criteria for evaluation: Safety
Primary safety endpoint
(Serious) Adverse Events
Criteria for evaluation: Feasibility
Feasibility
Proportion of successful DTM trials
Technical feasibility
- Battery consumption/ recharge frequency
- Prevalence of technical issues with regard to DTM SCS programming
- DTM stimulation parameters
- Technical IPG details
Study status
Recruitment has started in UZ Brussel and Vitaz.
Publications
No publications yet.
Contact
Please contact stimulusresearchgroup@gmail.com for more information about the trial.
