Evaluating the effectiveness of 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 clinical trial aims to determine whether spinal cord stimulation (SCS) is more effective than a placebo in reducing chronic postoperative neuropathic leg pain in patients who have undergone lumbar spinal surgery. The study employs a multicenter, double-blind, randomized, sham-controlled design, where participants will receive either active or subthreshold stimulation over a 12-month period. The primary outcome will be assessed through changes in leg pain intensity scores, alongside secondary measures including quality of life and medication use. Participants must demonstrate adequate pain relief during a preliminary test trial to qualify for the study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* History consistent with PSPS2 of at least 6 months after the last spinal surgery. The patient experienced no effect of conservative treatments and has been assessed as not eligible for further spinal surgery.
* Patients between 18-70 years of age.
* Average perceived pain intensity in one or both legs of 5 or more and average perceived pain intensity in the back of less than 3 measured with the validated 11-box NRS (0 no pain, 10 worst imaginable pain)
* The patient should have been informed verbally and in writing about the study and should have provided informed written consent to participate.
* Adequate pain relief effect (50% or more) after a two week trial with active test stimulation.

Exclusion Criteria:

* Subject is unable to understand or operate the SCS device.
* Subject currently has an active implantable device including pacemakers, spinal cord stimulator or intrathecal drug delivery system.
* Ongoing coagulation disorder.
* Ongoing abuse of alcohol, drugs, or prescription opioids.
* Active debilitating psychiatric illness.
* Active malignancy.
* Condition with increased general infection sensitivity, such as known immunodeficiency.
* Expected lifespan \<1 year.
* Ongoing local infection or other skin disease where the IPG is planned to be placed.
* Pregnancy.

Where it's running

• Department of Anaesthesiology and Pain Management, Rijnstate Hospital
  Arnhem, Netherlands Recruiting
• Department of Neurosurgery, Stavanger University hospital
  Stavanger, Norway Recruiting
• Department of Neurosurgery, Sahlgrenska University Hospital
  Gothenburg, Sweden Recruiting
• Department of Anesthesiology and Intensive Care/Pain Center, Sahlgrenska University Hospital Östra
  Gothenburg, Sweden Recruiting

Study contacts

• Principal investigator: Kliment Gatzinsky, MD, PhD — Department of Neurosurgery, Sahlgrenska University Hospital
• Study coordinator: Kliment Gatzinsky, MD, PhD
• Email: kliment.gatzinsky@neuro.gu.se
• Phone: +46733407733

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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.