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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and at 4, 10, 16, 26, and 52 weeks post-surgery

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

Inadequate analgesia

Back pain

100%

80%

60%

40%

20%

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

0 / 1Eligibility criteria met