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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain, Postoperative; Neuropathic Pain
• Intervention / Treatment: Device: Spinal Cord Stimulation

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 Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lutz Weise, MD, PhD; Phone Number: 902-472-6850; Email: lutz.weise@nshealth.ca

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
      • Queen Elizabeth Health Science Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stimulation On; Spinal cord stimulators will be optimized to each participant and then programmed to deliver high frequency stimulation below detectable threshold for 6 weeks.	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.
Placebo Comparator: Stimulation Off; Spinal cord stimulators will be optimized to each participant as in the experimental arm, and then programmed to deliver no stimulation for 6 weeks.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Nova Scotia Health Authority
• Investigators: Principal Investigator: Lutz Weise, MD, PhD, Nova Scotia Health Authority

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: April 25, 2024
• First Submitted That Met QC Criteria: April 25, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Spinal cord stimulation; Post intra-thoracic surgery pain syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pain, Postoperative; Neuralgia
• Other Study ID Numbers: SCS2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No