Clinical trial NCT06390150: Spinal Cord Stimulation Pioneering Analgesia for Resilient Recovery in Post Intra-Thoracic Surgery Pain
Official title: Spinal Cord Stimulation Pioneering Analgesia for Resilient Recovery in Post Intra-Thoracic Surgery Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain, Postoperative
Neuropathic Pain
Keywords: Spinal cord stimulation
Post intra-thoracic surgery pain syndrome
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study will be conducted as a placebo-controlled, crossover, randomized clinical trial of the intervention spinal cord stimulation for the indication neuropathic pain following intra-thoracic surgery. Following a 4-week recovery period post-surgery, participants will be randomly assigned to Group A (stimulation on, treatment) or Group B (stimulation off, placebo). After 6 weeks, participants will cross-over into the other treatment arm for another 6 weeks (Group A, stimulation off, placebo; Group B, stimulation on, treatment). All participants will then have stimulation turned on for the remainder of the study.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of post intra-thoracic surgery pain syndrome
* Medically fit for neurosurgery
* Informed consent

Exclusion Criteria:

* Previous spinal cord stimulation
* Uncontrolled psychiatric comorbidities and substance abuse
* Electrical or other devices that preclude implantation of a spinal cord stimulator device
* Lack of informed consent

Primary outcomes:
measure: Change from baseline on the Numerical Rating Scale (NRS) for pain intensity
timeFrame: Baseline and at 4, 10, 16, 26, and 52 weeks post-surgery
Secondary outcomes:
measure: Change in score on Oswestry Disability Index
timeFrame: Baseline and at 4, 10, 16, 26, and 52 weeks post-surgery
measure: Change in score on EuroQol 5 Dimension Questionnaire
timeFrame: Baseline and at 4, 10, 16, 26, and 52 weeks post-surgery
measure: Change in morphine equivalents used
timeFrame: Baseline and at 4, 10, 16, 26, and 52 weeks post-surgery
measure: Change in score on the Brief Pain Inventory Short Form
timeFrame: Baseline and at 4, 10, 16, 26, and 52 weeks post-surgery
measure: Change in score on the 12-item Short Form Survey
timeFrame: Baseline and at 4, 10, 16, 26, and 52 weeks post-surgery
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Queen Elizabeth Health Science Centre
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health Authority
name: Lutz Weise, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: