DETECT

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 and leg 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 chronic low back and leg pain due to Persistent Spinal Pain Syndrome Type II will be included.

The study is registered at ClinicalTrials.gov under number NCT05068011.

Effectiveness endpoints

• Overall pain, defined as a combination of back and leg pain (but not pain from other body parts), measured with the Visual Analogue Scale (VAS).
• Leg pain intensity
• Back pain intensity
• Disability
• Medication use
• Quality of life
• Patient global impression of change
• Clinical holistic responder status
• Patient activation measure-13 (PAM)
• Pain catastrophizing
• Symptoms of central sensitization
• Anxiety and Depression
• Work status
• Healthcare utilisation
• Time spent in seven body postures

Safety 

• (Serious) Adverse Events

Feasibility                          

• Proportion of successful DTM trials
• Battery consumption / recharge frequency
• Prevalence of technical issues with regard to DTM SCS programming
• DTM stimulation parameters