Spinal Cord Stimulation Pioneering Analgesia for Resilient Recovery in Post Intra-Thoracic Surgery Pain — SPARK  

Pain, Postoperative Clinical Trial

Official title: Spinal Cord Stimulation Pioneering Analgesia for Resilient Recovery in Post Intra-Thoracic Surgery Pain

Status Not yet recruiting

Clinical Trial Summary

This study aims to determine the effectiveness of spinal cord stimulation in patients with post intra-thoracic surgery pain syndrome in a placebo-controlled, crossover, randomized clinical trial.

Clinical Trial Description

Post intra-Thoracic surgery Pain Syndrome (PTPS) is a debilitating condition marked by persistent neuropathic pain in the surgical incision area for at least 2 months after the initial procedure. Proper pain control is instrumental in allowing patients to ambulate and breathe normally, without the need for splinting, and to take deep breaths necessary for effective coughing. The most common surgeries leading to PTPS are video-assisted thoracoscopic surgery (VATS) and (open) thoracotomy. The prevalence of PTPS has been reported between 5-70%, underscoring the high risk of severe chronic postoperative pain associated with thoracic surgery. Spinal cord stimulation (SCS), known for its efficacy in neuropathic pain of any origin, emerges as a potential solution. SCS can be regarded as an effective, safe, well-tolerated, and reversible treatment for severe drug-refractory neuropathic pain. While chronic pain guidelines strongly recommend SCS for certain conditions, such as persistent pain following spinal surgery, it is not typically listed as an option for PTPS. SCS appears promising for treating PTPS, particularly when a patient is resistant to other treatments and driven by neuropathic mechanisms. The potential for sustained pain relief, improved quality of life, and the prospect of reducing or discontinuing medication suggest that SCS may significantly impact the daily lives of individuals suffering from PTPS. This study aims to determine the effectiveness of SCS, which involves the placement of an implantable pulse generator connected to electrodes with leads that stimulate the spinal cord, in patients with PTPS. The hypothesis is that SCS leads to a reduction from baseline in the severity of pain in the Numeric Rating Scale (NRS) score, as well as an improvement in quality of life. ;

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Pain, Postoperative

• NCT number: NCT06390150
• Study type: Interventional
• Source: Nova Scotia Health Authority
• Contact: Lutz Weise, MD, PhD
• Phone: 902-472-6850
• Email: lutz.weise@nshealth.ca
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Completion date: July 2027