Comparing active and passive spinal cord stimulation for chronic pain relief

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 multicenter randomized clinical trial aims to evaluate the effectiveness of two types of burst spinal cord stimulation (SCS) - active recharge and passive recharge - in patients suffering from Persistent Spinal Pain Syndrome Type 2. A total of 96 participants will be recruited from six hospitals in the Netherlands and will be randomly assigned to receive either type of stimulation. The study will assess pain relief and emotional aspects of pain through various questionnaires over a 12-month period following implantation. The primary outcome will be measured using the pain catastrophizing score at six months, alongside several secondary outcomes to provide a comprehensive understanding of the treatment effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subjects between 18 and 70 years of age
* At least moderate level of catastrophizing as measured with the Pain catastrophizing scale (PCS) of at least 20 at first visit of the pain clinic.
* Chronic pain diagnoses as PSPS Type 2 of at least 6 months
* Neurologic exam without marked motor deficit.
* LBP and/or leg pain intensity should be 5 or higher measured with the 11-box NRS 0-10
* Meets all the inclusion criteria for the implantation of a neurostimulation system as typically utilized in the study center. PM: depression is not an exclusion criteria
* Subject has been screened by a multi-disciplinary panel including a psychologist and deemed suitable for implantation
* Subject is able and willing to comply with the follow-up schedule and protocol
* Subject is able to provide written informed consent

Exclusion Criteria:

* Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study
* Escalating or changing pain condition within the past month as evidenced by investigator examination
* BMI ≥35
* "Subject has had injection therapy or radiofrequency treatment for their low back pain (LBP) or leg pain within the past 3 months"
* Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump
* Subject is unable to operate the device
* Severe spinal column degeneration likely to cause technical problems with neuromodulation, to be assessed by the treating physician
* Previous Neurostimulation therapy

Where it's running

• Rijnstate Hospital
  Arnhem, Gelderland, Netherlands Recruiting
• Bravis Hospital
  Roosendaal, North Brabant, Netherlands Recruiting
• Elizabeth TweeSteden Hospital
  Tilburg, North Brabant, Netherlands Recruiting
• Amsterdam University Medical Hospitals A-UMC
  Amsterdam, North Holland, Netherlands Recruiting
• Diakonessen Hospital
  Zeist, Utrecht, Netherlands Recruiting
• Alrijne Hospital
  Leiderdorp, South Holland, Netherlands Not yet recruiting

Study contacts

• Study coordinator: Martijn Mons, Msc.
• Email: m.mons@maastrichtuniversity.nl
• Phone: +31433881034

Similar studies

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

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• Helping patients with persistent spinal pain return to work

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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.