Comparing subthreshold spinal cord stimulation to best medical treatment for persistent spinal pain
The Holistic Response of Patients With Persistent Spinal Pain Syndrome Type II by Subthreshold Spinal Cord Stimulation Compared to Best Medical Treatment, Investigated by a Multicentric Randomized Controlled Trial
NA · Universitair Ziekenhuis Brussel · NCT05169047
This study is testing if a new type of spinal cord stimulation can help people with ongoing spinal pain feel better compared to the best medical treatments currently available.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 114 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitair Ziekenhuis Brussel (other) |
| Locations | 5 sites (Hasselt and 4 other locations) |
| Trial ID | NCT05169047 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of subthreshold spinal cord stimulation (SCS) compared to best medical treatment (BMT) in patients suffering from Persistent Spinal Pain Syndrome Type 2 (PSPS-T2). The study will assess the percentage of clinical holistic responders at 6 months, as well as improvements in self-management, work status, and pain relief. Patients will be randomly assigned to either treatment group, with the option to switch treatments based on their response. The trial seeks to provide high-quality evidence to guide treatment choices for this challenging condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with chronic pain from PSPS-T2 that has not responded to conservative treatments.
Not a fit: Patients with active psychiatric disorders or other chronic illnesses characterized by widespread pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with persistent spinal pain, potentially improving their quality of life.
How similar studies have performed: While there is limited direct evidence comparing subthreshold SCS to BMT, similar studies on spinal cord stimulation have shown promising results in pain management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Persistent Spinal Pain Syndrome Type II (PSPS-T2) * Chronic pain as a result of PSPS-T2 that exists for at least 6 months with a pain intensity of at least 4/10 on the Numeric Rating Scale, refractory to conservative treatment. * PSPS-T2 patients eligible for subthreshold SCS * 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 patients to receive or properly operate the spinal cord stimulation system * Evidence of an active psychiatric disorder * Suffering from another chronic illness characterised by chronic generalized widespread pain (e.g. rheumatoid arthritis, fibromyalgia, chronic fatigue syndrome, scleroderma). * Pregnancy
Where this trial is running
Hasselt and 4 other locations
- Jessa Ziekenhuis — Hasselt, Belgium (RECRUITING)
- Universitair Ziekenhuis Brussel — Jette, Belgium (RECRUITING)
- Emmaüs, AZ Sint-Maarten — Mechelen, Belgium (RECRUITING)
- AZ Delta — Roeselare, Belgium (RECRUITING)
- AZ Turnhout — Turnhout, 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.
Conditions: Failed Back Surgery Syndrome