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Patients treated with a temporary PNS system for Osteoarthritis
N/A
Recruiting
Led By Mansoor M Aman, MD
Research Sponsored by Mansoor Aman, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 months post lead pull
Awards & highlights
Study Summary
The purpose of this study is to demonstrate the treatment outcomes of patients with chronic knee pain secondary to osteoarthritis that have received a temporary peripheral nerve stimulation system.
Eligible Conditions
- Osteoarthritis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 and 12 months post lead pull
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 months post lead pull
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average change from baseline to end of treatment in average pain intensity measured through BPI-SF item 5.
Secondary outcome measures
Average change from baseline to 6- and 12-months post-explant in health-related quality of life measured through PROMIS-29.
Average change from baseline to 6- and 12-months post-explant in pain interference measured through BPI-SF.
Average change from baseline to 7- and 30-days post-implant; and 6- and 12-months post-explant in average pain intensity measured through BPI-SF item 5.
+7 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Patients treated with a temporary PNS systemExperimental Treatment1 Intervention
These patients will receive a temporary PNS system for their knee pain secondary to osteoarthritis
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Who is running the clinical trial?
Mansoor Aman, MDLead Sponsor
1 Previous Clinical Trials
169 Total Patients Enrolled
Mansoor M Aman, MDPrincipal InvestigatorDirector, Interventional Pain Medicine- Oshkosh & Fond du Lac Department of Anesthesiology
1 Previous Clinical Trials
169 Total Patients Enrolled
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