Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06390150
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-25
Brief Title:
Spinal Cord Stimulation Pioneering Analgesia for Resilient Recovery in Post Intra-Thoracic Surgery Pain
Sponsor:
Nova Scotia Health Authority
Organization:
Nova Scotia Health Authority
Study Overview
Official Title:
Spinal Cord Stimulation Pioneering Analgesia for Resilient Recovery in Post Intra-Thoracic Surgery Pain
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPARK
Brief 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
Detailed 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None