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

Pain, Postoperative Clinical Trial

— SPARK  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06390150
• Other study ID #: SCS2024
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: July 2027

Study information

• Verified date: April 2024
• Source: Nova Scotia Health Authority
• Contact: Lutz Weise, MD, PhD
• Phone: 902-472-6850
• Email: lutz.weise[@]nshealth.ca
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: July 2027
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Pain, Postoperative

Intervention

Device:
• Spinal Cord Stimulation
The spinal cord stimulator is an implantable pulse generator connected to electrodes with leads that stimulate the spinal cord. The device is programmed to deliver therapeutic stimulation to treat pain.

Locations

Country	Name	City	State
Canada	Queen Elizabeth Health Science Centre	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline on the Numerical Rating Scale (NRS) for pain intensity	The primary outcome is the self-reported difference in change from baseline of the severity of pain quantified in the Numerical Rating Scale. This will be assessed at baseline (pre-surgery) and at regular follow-up appointments.	Baseline and at 4, 10, 16, 26, and 52 weeks post-surgery
Secondary	Change in score on Oswestry Disability Index	Assesses a patient's quality of life in relation to back pain on a 10-section questionnaire. A low score indicates no disability and a high score indicates severe disability.	Baseline and at 4, 10, 16, 26, and 52 weeks post-surgery
Secondary	Change in score on EuroQol 5 Dimension Questionnaire	Assesses overall quality of life in five dimensions including mobility, self-care, daily routine, pain, and anxiety/depression. A low score indicates poor health and a high score indicates excellent health.	Baseline and at 4, 10, 16, 26, and 52 weeks post-surgery
Secondary	Change in morphine equivalents used	Measures patient pain by assessing the amount of pain medication taken by a patient. Higher usage indicates a greater level of pain and a lower usage indicates a lower level of pain.	Baseline and at 4, 10, 16, 26, and 52 weeks post-surgery
Secondary	Change in score on the Brief Pain Inventory Short Form	Assesses the impact of pain on a patient's quality of life. A high score indicates a severe impact and a lower score indicates minimal impact.	Baseline and at 4, 10, 16, 26, and 52 weeks post-surgery
Secondary	Change in score on the 12-item Short Form Survey	Assesses how a patient's health impacts their quality of life. A higher score indicates a better quality of life, and a low score indicates a poorer quality of life.	Baseline and at 4, 10, 16, 26, and 52 weeks post-surgery