Open and Closed Loop DTM SCS in Patients With PSPS Type 2: ENDLESS Study

Universitair Ziekenhuis Brussel

Status: Not yet enrolling

Conditions: Persistent Spinal Pain Syndrome Type 2; Failed Neck Surgery Syndrome; Failed Back Surgery Syndrome

Treatments: Device: Spinal Cord Stimulation

Study type: Observational

Funder types: Other

Identifiers

NCT07211308

ENDLESS

Details and patient eligibility

About

Evaluation of the effectiveness of differential target multiplexed spinal cord stimulation for treatment of Persistent Spinal Pain Syndrome Type II (PSPS-T2). Identification of clinical effective parameters concerning frequency, pulse duration, amplitude and battery consumption/recharge frequency and safety evaluation.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• having chronic pain as a result of PSPS-T2 that exists for at least 6 months with at least moderate pain intensity (4 or higher measured on numeric rating scale (NRS) or 31mm or higher measured on visual analogue scale (VAS) for the dominant pain location.
• being offered treatment with DTM SCS
• being at least 18 years old

Exclusion criteria

• Expected inability of patients to properly operate the SCS system
• History of coagulation disorders, lupus erythematosus, diabetic neuropathy
• Active malignancy
• Addiction to drugs and/or alcohol (more than 5 units /day)
• Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to complete questionnaires, as determined by the investigator
• Immune deficiency (e.g. HIV positive, immunosuppressiva)
• Life expectancy < 1 year
• Local infection or other skin disorder at site of incision
• Pregnancy
• Other implanted active medical device