Comparing subthreshold spinal cord stimulation to best medical treatment for persistent spinal pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.