Transcriptomic Profile of Patients Treated With Different Modalities of Spinal Cord Stimulation

Launched by HOSPITAL GENERAL UNIVERSITARIO DE VALENCIA · Jan 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a condition called Failed Back Surgery Syndrome (FBSS), which occurs when patients continue to experience severe pain even after having surgery on their back. The researchers want to learn more about how spinal cord stimulation (SCS) therapy can help these patients and what biological markers might indicate how well the therapy is working. They will analyze blood samples from 40 patients who are experiencing chronic pain due to FBSS and are receiving different types of SCS treatment. The goal is to identify potential markers that could help diagnose pain and predict how patients will respond to SCS therapy.

To be eligible for this trial, participants need to be adults aged 18 to 65 who have had ongoing severe pain (rated over 6 out of 10) for more than six months, despite trying various treatments. However, patients with serious health issues that could complicate their pain or those with certain psychological concerns will not be included. If you join the study, you can expect to provide blood samples and be part of efforts to improve understanding and treatment of chronic pain related to FBSS. This research is important because it may lead to better management of pain for those who struggle with it after surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult patients affected by FBSS, defined as "surgical end stage after one or several interventions on the lumbar neuroaxis indicated to relief lower back pain, root pain or the combination of both, without effect"
• • Age between 18 and 65 years
• • Severe pain measured on a numerical rating scale (NRS \> 6/10), more than six months of evolution
• • Refractory pain despite having carried out pharmacological treatment according to WHO's stratified approach; physical/rehabilitation therapy and/or interventional procedures (e.g. epidural steroid injections, radiofrequency, epiduroscopy/adhesiolysis)
• Exclusion Criteria:
• • Patients with severe associated comorbidities (e.g. severe high blood pressure, diabetes mellitus, peripheral vasculopathy, severe heart disease, etc...) that may in themselves cause pain or aggravate the existence of previous pain.
• • Extensive osteosynthesis encompassing the thoraco-lumbar region where the tips of the electrodes are routinely positioned.
• • Abnormal pain behavior, unresolved psychiatric illness, unresolved issues of secondary gain or inappropriate medication use
• • Patients not consenting or refusing to participate will be excluded
• • Negative evaluation of the psychologist previous to the implant