Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
Inclusion Criteria
Having informed consent
I have pain after chest surgery.
I am healthy enough for brain surgery.
Exclusion Criteria
History of previous spinal cord stimulation
Presence of electrical or other devices that preclude implantation of a spinal cord stimulator device
Lack of informed consent
+1 more
Participant Groups
This study is looking at how well spinal cord stimulation helps with pain after chest surgery. It's a controlled trial where patients are randomly chosen to receive either the real treatment or a placebo, and then they switch.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Stimulation OnExperimental Treatment1 Intervention
Spinal cord stimulators will be optimized to each participant and then programmed to deliver high frequency stimulation below detectable threshold for 6 weeks.
Group II: Stimulation OffPlacebo Group1 Intervention
Spinal cord stimulators will be optimized to each participant as in the experimental arm, and then programmed to deliver no stimulation for 6 weeks.
Spinal Cord Stimulation is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Spinal Cord Stimulation for:
- Failed back surgery syndrome (FBSS)
- Adhesive arachnoiditis
- Peripheral causalgia/neuropathy
- Reflex sympathetic dystrophy (RSD)
- Phantom limb/stump pain
- Ischemic pain of vascular origin
- Complex regional pain syndrome
- Pain after an amputation
- Visceral abdominal pain and perineal pain
🇪🇺 Approved in European Union as Spinal Cord Stimulation for:
- Chronic pain
- Neuropathic pain
- Spinal cord injury pain
- Failed back surgery syndrome (FBSS)
- Adhesive arachnoiditis
- Peripheral causalgia/neuropathy
- Reflex sympathetic dystrophy (RSD)
🇨🇦 Approved in Canada as Spinal Cord Stimulation for:
- Chronic pain
- Neuropathic pain
- Spinal cord injury pain
- Failed back surgery syndrome (FBSS)
- Adhesive arachnoiditis
- Peripheral causalgia/neuropathy
- Reflex sympathetic dystrophy (RSD)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Queen Elizabeth Health Science CentreHalifax, Canada
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Who Is Running the Clinical Trial?
Nova Scotia Health AuthorityLead Sponsor