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Procedure

Spinal Cord Stimulation for Postoperative Pain (SPARK Trial)

N/A
Waitlist Available
Led By Lutz Weise, MD, PhD
Research Sponsored by Nova Scotia Health Authority
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of post intra-thoracic surgery pain syndrome
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and at 4, 10, 16, 26, and 52 weeks post-surgery
Awards & highlights

Summary

This trial will test if spinal cord stimulation is effective in treating pain in patients who have had thoracic surgery.

What is being tested?
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have pain after chest surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and at 4, 10, 16, 26, and 52 weeks post-surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and at 4, 10, 16, 26, and 52 weeks post-surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline on the Numerical Rating Scale (NRS) for pain intensity
Secondary study objectives
Change in morphine equivalents used
Change in score on EuroQol 5 Dimension Questionnaire
Change in score on Oswestry Disability Index
+2 more

Side effects data

From 2019 Phase 4 trial • 30 Patients • NCT03284411
10%
Device stimulation issue
3%
Inadequate analgesia
3%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Spinal Cord Stimulation

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spinal Cord Stimulation
2020
Completed Phase 4
~420

Find a Location

Who is running the clinical trial?

Nova Scotia Health AuthorityLead Sponsor
286 Previous Clinical Trials
94,240 Total Patients Enrolled
1 Trials studying Postoperative Pain
50 Patients Enrolled for Postoperative Pain
Lutz Weise, MD, PhDPrincipal InvestigatorNova Scotia Health Authority
2 Previous Clinical Trials
120 Total Patients Enrolled
~16 spots leftby Jun 2026
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