Radiofrequency Ablation for Chronic Knee Pain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Chronic Knee PainRadiofrequency Ablation - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this study is to assess how clinically useful and safe genicular nerve radiofrequency ablation is in people with chronic pain after total knee arthroplasty performed for osteoarthritis.

Treatment Effectiveness

Study Objectives

3 Primary · 10 Secondary · Reporting Duration: 1-, 3-, and 6-month visits

1-, 3-, and 6-month visits
Chair Stand Test
Daily Step Count
Pharmaceutical Preparations
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Physical Activity Scale for the Elderly (PASE)
Knee
Quality of Life Measured using Patient Reported Outcome Measurement Information System (PROMIS) Global 10
Walk Test
3 months
Acceptability by actively treated participants Outcome
Efficacy Outcome
Activation Analysis
6 months
Pain
Safety Outcome

Trial Safety

Trial Design

2 Treatment Groups

Radiofrequency Ablation
1 of 2
Sham
1 of 2

Active Control

Non-Treatment Group

30 Total Participants · 2 Treatment Groups

Primary Treatment: Radiofrequency Ablation · Has Placebo Group · N/A

Sham
Device
ShamComparator Group · 1 Intervention: Sham · Intervention Types: Device
Radiofrequency Ablation
Device
ActiveComparator Group · 1 Intervention: Radiofrequency Ablation · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1-, 3-, and 6-month visits

Who is running the clinical trial?

Tufts Medical CenterLead Sponsor
238 Previous Clinical Trials
244,953 Total Patients Enrolled
Boston UniversityOTHER
420 Previous Clinical Trials
10,038,921 Total Patients Enrolled
Timothy E McAlindon, MD, MPHPrincipal InvestigatorTufts Medical Center
1 Previous Clinical Trials
30 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a chronic knee pain and are over 18 years of age.
You have had knee replacement surgery at least one year ago.
You are willing to complete all study procedures, including a daily pain NRS, AE, and medication usage questions via daily notification.
You have had knee pain for at least one month during the previous six months.