Clinical trial NCT02931435: Radiofrequency For Chronic Knee Pain Post-Arthroplasty
Official title: Radiofrequency For The Treatment Of Chronic Knee Pain Following Total Knee Arthroplasty: A Double-Blind Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Knee Pain
Osteoarthritis, Knee
Keywords: Genicular Radiofrequency Ablation
Knee Arthroplasty, Total
Lead sponsor: Willis-Knighton River Cities Clinical Research Center
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
name: Abbott
First posted: 2016-10-13
Enrollment: 9
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic knee osteoarthritis (OA) is one of the most common diseases with increasing prevalence in advanced age. Knee OA results in movement restriction, sleep disturbance, and disability. Total knee arthroplasty (TKA) is employed often in the symptomatic treatment of knee OA. It has been estimated that 3.4 million TKAs will be performed in the year 2030 in the United States alone. Many studies report rewarding outcomes for patients, but other research shows there are many patients that remain dissatisfied post-arthroplasty.

The purpose of this study is to evaluate whether genicular radiofrequency ablation can relieve chronic post-arthroplasty knee pain.

Detailed description: Chronic knee osteoarthritis (OA) is one of the most common diseases with increasing prevalence in advanced age. Knee OA results in movement restriction, sleep disturbance, and disability. Total knee arthroplasty (TKA) is employed often in the symptomatic treatment of knee OA. It has been estimated that 3.4 million TKAs will be performed in the year 2030 in the United States alone. Many studies report rewarding outcomes for patients, but other research shows there are many patients that remain dissatisfied post-arthroplasty.

As the prevalence of knee arthroplasty increases, so does the frequency of revisions. It has been found that 20% of patients reporting painful knee arthroplasties were not able to be diagnosed with a specific cause and were therefore referred to a pain specialist. Pharmacologic therapy and non-surgical interventions are often employed with minimal benefit to the patient's level of disability as indicated by clinical evidence.

Genicular radiofrequency ablation seems to be a safe, effective and minimally invasive therapy for chronic knee OA patients who have had a positive diagnostic block. No study has determined whether genicular radiofrequency ablation can relieve chronic post-arthroplasty knee pain. The investigators propose to examine the effect of genicular radiofrequency ablation in chronic post-arthroplasty knee pain in patients who respond positively to diagnostic nerve blocks.

Eligibility criteria: Inclusion Criteria:

* Study candidate must provide written informed consent.
* Must be ≥ 50 years of age at the time of consent
* Chronic knee pain despite total knee arthroplasty at least 6 months prior to consent
* Orthopedic evaluation indicating no further surgery is warranted
* Stable pain medication regimen for 30 days prior to baseline visit
* Knee pain is primary pain complaint

Exclusion Criteria:

* Acute knee pain
* Connective tissue disorders affecting the knee
* Serious neurologic or psychiatric disorders that would affect the outcome of the study as determined by the Principal Investigator
* Steroid or hyaluronic acid injections into the affected knee in the past 3 months
* Confounding pain conditions of the index leg that may affect medication requirements or study outcomes

Primary outcomes:
measure: Mean difference in knee pain intensities as indicated on the Visual Analog Scale
timeFrame: Baseline and 6 weeks post-radiofrequency ablation
Secondary outcomes:
measure: Change in Visual Analog Score of average knee pain
timeFrame: Baseline to 1 week, 6 weeks, and 12 weeks
measure: Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Baseline to 1 week, 6 weeks, and 12 weeks
measure: Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Baseline to 1 week, 6 weeks, and 12 weeks
measure: Change of Patient Global Assessment
timeFrame: Baseline to 1 week, 6 weeks, and 12 weeks
measure: Satisfaction with Radiofrequency Procedure
timeFrame: Baseline to 1 week, 6 weeks, and 12 weeks
measure: Rate of procedure-related Adverse Events
timeFrame: From informed consent through study completion, up to 20 weeks
measure: Rate of Serious Adverse Events
timeFrame: From informed consent through study completion, up to 20 weeks
Other outcomes:
Locations:
city: Shreveport
country: United States
facility: WK River Cities Clinical Research Center
state: Louisiana
Study officials:
affiliation: WK River Cities Clinical Research Center
name: Randall Brewer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
citation: Nikolaou VS, Chytas D, Babis GC. Common controversies in total knee replacement surgery: Current evidence. World J Orthop. 2014 Sep 18;5(4):460-8. doi: 10.5312/wjo.v5.i4.460. eCollection 2014 Sep 18.
citation: Choi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, Shin JW. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain. 2011 Mar;152(3):481-487. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4.
citation: Al-Hadithy N, Rozati H, Sewell MD, Dodds AL, Brooks P, Chatoo M. Causes of a painful total knee arthroplasty. Are patients still receiving total knee arthroplasty for extrinsic pathologies? Int Orthop. 2012 Jun;36(6):1185-9. doi: 10.1007/s00264-011-1473-6. Epub 2012 Jan 11.