Evaluating spinal cord stimulation for chronic back and leg pain
Differential Target Multiplexed Spinal Cord Stimulation: a Multicenter Cohort Study
This study is testing a new spinal cord stimulation method to see if it can help people with ongoing back and leg pain after surgery feel better and improve their daily activities.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitair Ziekenhuis Brussel Academic / other |
| Locations | 14 sites (Jette, Brussels Capital and 13 other locations) |
| Trial ID | NCT05068011 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of differential target multiplexed spinal cord stimulation (DTM SCS) in treating chronic back and leg pain associated with Failed Back Surgery Syndrome and Persistent Spinal Pain Syndrome Type 2. It aims to analyze the outcomes of patients receiving DTM SCS, with a specific focus on comparing the effectiveness of paddle/surgical leads versus percutaneous leads. Participants will be monitored over time to assess pain relief and functional improvement. The study includes patients who have experienced severe chronic pain for at least six months and are suitable candidates for this treatment.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with severe chronic pain due to Failed Back Surgery Syndrome or Persistent Spinal Pain Syndrome Type 2.
Not a fit: Patients with conditions that may impair their ability to operate the spinal cord stimulation system or those with active malignancies or severe psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide significant pain relief and improved quality of life for patients suffering from chronic pain.
How similar studies have performed: While spinal cord stimulation has been studied previously, this specific approach of differential target multiplexed stimulation is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with severe chronic pain (\> 5 on numeric rating scale, NRS) for at least 6 months due to FBSS (PSPS T2) and suitable for treatment with DTM SCS according to the treating physician * Age \> 18 years * Patient has been informed of the study procedures and has given written informed consent * Patient willing to comply with study protocol including attending the study visits Exclusion Criteria: * Expected inability of the patient to receive or properly operate the spinal cord stimulation system * History of coagulation disorder, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis, or morbus Bechterew * Active malignancy * Addiction to drugs, alcohol (\>5 units per day) and/or medication * Evidence of an active disruptive psychiatric disorder or other known condition that may impact perception of pain, compliance to the intervention, and/or ability to evaluate treatment outcome as determined by investigator * Immune deficiency (e.g. HIV positive, immunosuppressive treatment) * Life expectancy \< 1 year * Local infection or any other skin disorder at site of incision * Pregnancy * Other implanted active medical device
Where this trial is running
Jette, Brussels Capital and 13 other locations
- Universitair Ziekenhuis Brussel — Jette, Brussels Capital, Belgium (Recruiting)
- Zna — Antwerp, Belgium (Recruiting)
- AZ Sint-Jan Brugge-Oostende — Bruges, Belgium (Recruiting)
- AZ Sint-Lucas Brugge — Bruges, Belgium (Recruiting)
- Jessa Ziekenhuis — Hasselt, Belgium (Recruiting)
- AZ Groeninge — Kortrijk, Belgium (Recruiting)
- UZ Leuven — Leuven, Belgium (Recruiting)
- Heilig Hart Ziekenhuis Lier — Lier, Belgium (Recruiting)
- Centre Hospitalier Régional (CHR) de la Citadelle — Liège, Belgium (Recruiting)
- AZ Sint-Maarten — Mechelen, Belgium (Recruiting)
- AZ Delta — Roeselare, Belgium (Recruiting)
- Vitaz — Sint-Niklaas, Belgium (Recruiting)
- AZ Turnhout — Turnhout, Belgium (Recruiting)
- Gza — Wilrijk, Belgium (Recruiting)
Study contacts
- Study coordinator: Maarten Moens, prof.dr.
- Email: maarten.moens@uzbrussel.be
- Phone: +3224775514
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.