Chronic Knee PainRACKTKANCT05473663
Radiofrequency Ablation After Total Knee Arthroplasty
A study testing Radiofrequency Ablation in people with Chronic Knee Pain, run by University of Massachusetts, Worcester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Knee Pain
- What is being tested?
- Radiofrequency Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible individuals over 18 years of age in general good health apart from their chronic knee pain
- At least one year post-TKA
- Report of chronic knee pain classified using a standard question about the presence of "pain, aching, or stiffness in the knee on most days for at least one month during the prior 6 months"
- In an unacceptable symptom state classified using a validated question: "Think about all consequences of your arthroplasty in the last week. If you were to remain for the rest of your life as you were during the last week, would the current state be acceptable or unacceptable for you?"
- Willingness to complete all the study procedures, including a daily pain NRS, AE, and medication usage questions via daily notification
- Subjects must have read and understood the informed consent form (ICF), and must have signed and dated it prior to any study-related procedure being performed
Who cannot join
- Pregnant women, breastfeeding women, and women who are not post-menopausal (defined at 12 months with no menses without an alternative medical cause) or permanently surgically sterile (includes hysterectomy, bilateral salpingectomy, and bilateral oophorectomy)
- Women who are not post-menopausal or permanently surgically sterile who are sexually active, and who are not willing to use birth control as outlined in Section 5.3.1 during the study period
- Significant evidence of infection within the knee or radiographic evidence of prosthesis loosening as defined by the orthopedic surgeon
- Individuals with pain exclusively located in the posterior knee, evaluated systematically using a validated Knee Pain Map
- Individuals who do not achieve a 70% pain reduction following the initial prognostic block, consistent with clinical practice
- Participation in a clinical research trial that included the receipt of an investigational product (IP) or any experimental therapeutic procedure within 30 days prior to the Screening Visit, or planned participation in any such trial
- Use of anticoagulants and inability to withhold for three days prior to the study RFA procedure with clearance by the prescribing physician
- Other conditions that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655
About this study
Official title: A 6-month, Double-blinded, Sham-controlled Clinical Trial Assessing the Clinical Usefulness of Radiofrequency Ablation for Chronic Knee Pain After Total Knee Arthroplasty
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.
- Conditions
- Chronic Knee Pain
- Being tested
- Radiofrequency Ablation, Sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency AblationDevice
Genicular nerve RFA is a standard outpatient procedure using fluoroscopic guidance to ensure accurate placement of the radiofrequency cannula. After placement of the radiofrequency cannula, nerve stimulation is performed to confirm proper position and ensure that the cannula is not too close to motor fibers. One mL of 2% lidocaine is placed at each of the cannulas. The RFA treatment is then proceeded by rhizotomizing each genicular nerve at 80°C for 90 seconds with a 15-second ramp-up.
ShamDevice
Is performed identically to the active treatment but without the application of the RFA current
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency Ablation | Active comparator | Patient undergoing genicular nerve radiofrequency ablation. Receives: Device: Radiofrequency Ablation |
| Sham | Sham comparator | Patient undergoing sham. Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability by actively treated participants Outcome
Our a priori decision rule for acceptability of RFA will be that 50% of the actively treated participants respond affirmatively at the 3-month visit: "Would you recommend the treatment used in this study to someone in a similar situation with knee pain after a knee replacement?"
Measured: 3 months
Safety Outcome
<2 serious adverse events among 20 actively treated participants. After enrollment, participants will complete training regarding the daily notification for daily adverse event monitoring. During the study, participants will be automatically prompted daily to report adverse events on their mobile device or home computer. If a participant does not complete adverse event monitoring daily, a member of the study team will contact them to troubleshoot.
Additionally, a more thorough examination of patient safety will be conducted during the clinical exam in the 1-, 3-, and 6-month follow-up visits. Prosthesis safety will be assessed with skyline, lateral, and anteroposterior radiographs (e.g. aseptic loosening, osteolysis) at baseline and 6 months69. Serious adverse events will be consistent with our institution's IRB definitions and with a definition of serious adverse drug experience in FDA 21 CFR 312.32(a).
Measured: 6 months
Efficacy Outcome
<5 number needed to treat to achieve a patient-acceptable symptom state. Patient acceptable symptom state will be defined with the following question: "Think about all consequences of your arthroplasty in the last week. If you were to remain for the rest of your life as you were last week, would the current state be acceptable or unacceptable for you?"61 Primary efficacy measure will be whether a participant considers themselves in an acceptable symptom state at the 3-month visit after the intervention. A <5 number is needed to treat to achieve a patient-acceptable symptom state.
Measured: 3 months
Secondary outcomes (10)
Pain Number Rating Score (NRS)
Change from baseline in daily pain number rating scale (NRS) scores via text or online platform until study completion. Min= 0, Max=10. Larger change in scores mean a better outcome.
Measured: 6 months
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Change from baseline in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Activities of Daily Living subscales at 1-, 3-, and 6-month visits. Questions measured from 0-4. Min = 0 (none), Max= 4 (extreme). Larger change in scores mean a better outcome.
Measured: 1-, 3-, and 6-month visits
Physical Activity Scale for the Elderly (PASE)
Change from baseline in the Physical Activity Scale for the Elderly (PASE) at 1-, 3-, and 6-month visits. Measured based on frequency 0 (never)- 3 (often). Larger change in score means better outcome.
Measured: 1-, 3-, and 6-month visits
Quality of Life Measured using Knee Injury and Osteoarthritis Outcome Score Quality of Life (KOOS QOL)
Change from baseline in the KOOS Quality of Life subscale at 1-, 3-, and 6-month visits. not at all- extreme. Larger change in score means better outcome.
Measured: 1-, 3-, and 6-month visits
Quality of Life Measured using Patient Reported Outcome Measurement Information System (PROMIS) Global 10
Change from baseline in the PROMIS Global 10 at 1-, 3-, and 6-month visits.
Measured: 1-, 3-, and 6-month visits
Walk Test
Change from baseline in 20-meter walk test time at 1-, 3-, and 6 month visits
Measured: 1-, 3-, and 6-month visits
Chair Stand Test
Change from baseline in chair stand speed at 1-, 3-, and 6- month visits
Measured: 1-, 3-, and 6-month visits
Daily Step Count
Change from baseline in daily step count via Wearable Activity Monitor (i.e. Fitbit) averaged over the one week following 1-, 3-, and 6- month visits
Measured: 1-, 3-, and 6-month visits
Incidence of Pain Medication use
Change from baseline in usage of pain medication for target knee pain at 1-, 3-, and 6- month visits. Measured using questionnaire.
Measured: 1-, 3-, and 6-month visits
Gait Analysis
An optional sub-study will assess change from baseline in spatiotemporal metrics of gait at the 3 month visit. . Data collected will include knee kinematics and kinetics using optical motion capture and spatiotemporal gait parameters using wearable inertial sensors. Larger change from baseline means better outcome.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start1 Sep 2022
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Knee PainStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University, Tufts Medical Center, Rheumatology Research Foundation
- Responsible party
- Principal investigator, Timothy McAlindon, University of Massachusetts, Worcester
- Investigators
- Timothy E McAlindon, MD, MPH, Principal investigator, UMass Worcester (UMass Chan Medical School)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473663
- Sponsor's protocol ID
- STUDY00001815
- Acronym
- RACKTKA
- Status last verified
- Jan 2026
- First submitted
- 18 Jul 2022
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-month, Double-blinded, Sham-controlled Clinical Trial Assessing the Clinical Usefulness of Radiofrequency Ablation for Chronic Knee Pain After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05473663
- Acronym / sponsor ID
- RACKTKA / STUDY00001815
- Conditions
- Chronic Knee Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Boston University, Tufts Medical Center, Rheumatology Research Foundation
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency Ablation | Active comparator | Device: Radiofrequency AblationPatient undergoing genicular nerve radiofrequency ablation. |
| Sham | Sham comparator | Device: ShamPatient undergoing sham. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Eligible individuals over 18 years of age in general good health apart from their chronic knee pain
- At least one year post-TKA
- Report of chronic knee pain classified using a standard question about the presence of "pain, aching, or stiffness in the knee on most days for at least one month during the prior 6 months"
- In an unacceptable symptom state classified using a validated question: "Think about all consequences of your arthroplasty in the last week. If you were to remain for the rest of your life as you were during the last week, would the current state be acceptable or unacceptable for you?"
- Willingness to complete all the study procedures, including a daily pain NRS, AE, and medication usage questions via daily notification
Key exclusion criteria (8 listed)
- Pregnant women, breastfeeding women, and women who are not post-menopausal (defined at 12 months with no menses without an alternative medical cause) or permanently surgically sterile (includes hysterectomy, bilateral salpingectomy, and bilateral oophorectomy)
- Women who are not post-menopausal or permanently surgically sterile who are sexually active, and who are not willing to use birth control as outlined in Section 5.3.1 during the study period
- Significant evidence of infection within the knee or radiographic evidence of prosthesis loosening as defined by the orthopedic surgeon
- Individuals with pain exclusively located in the posterior knee, evaluated systematically using a validated Knee Pain Map
- Individuals who do not achieve a 70% pain reduction following the initial prognostic block, consistent with clinical practice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency AblationGenicular nerve RFA is a standard outpatient procedure using fluoroscopic guidance to ensure accurate placement of the radiofrequency cannula. After placement of the radiofrequency cannula, nerve stimulation is performed to confirm proper position and ensure that the cannula is not too close to motor fibers. One mL of 2% lidocaine is placed at each of the cannulas. The RFA treatment is then proceeded by rhizotomizing each genicular nerve at 80°C for 90 seconds with a 15-second ramp-up. | Device | Radiofrequency Ablation |
| ShamIs performed identically to the active treatment but without the application of the RFA current | Device | Sham |
Primary outcome
Acceptability by actively treated participants Outcome
Time frame: 3 months
Our a priori decision rule for acceptability of RFA will be that 50% of the actively treated participants respond affirmatively at the 3-month visit: "Would you recommend the treatment used in this study to someone in a similar situation with knee pain after a knee replacement?"
Safety Outcome
Time frame: 6 months
<2 serious adverse events among 20 actively treated participants. After enrollment, participants will complete training regarding the daily notification for daily adverse event monitoring. During the study, participants will be automatically prompted daily to report adverse events on their mobile device or home computer. If a participant does not complete adverse event monitoring daily, a member of the study team will contact them to troubleshoot. Additionally, a more thorough examination of patient safety will be conducted during the clinical exam in the 1-, 3-, and 6-month follow-up visits. Prosthesis safety will be assessed with skyline, lateral, and anteroposterior radiographs (e.g. aseptic loosening, osteolysis) at baseline and 6 months69. Serious adverse events will be consistent with our institution's IRB definitions and with a definition of serious adverse drug experience in FDA 21 CFR 312.32(a).
Efficacy Outcome
Time frame: 3 months
<5 number needed to treat to achieve a patient-acceptable symptom state. Patient acceptable symptom state will be defined with the following question: "Think about all consequences of your arthroplasty in the last week. If you were to remain for the rest of your life as you were last week, would the current state be acceptable or unacceptable for you?"61 Primary efficacy measure will be whether a participant considers themselves in an acceptable symptom state at the 3-month visit after the intervention. A <5 number is needed to treat to achieve a patient-acceptable symptom state.
10 secondary outcomes
Pain Number Rating Score (NRS)
Time frame: 6 months
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 1-, 3-, and 6-month visits
Physical Activity Scale for the Elderly (PASE)
Time frame: 1-, 3-, and 6-month visits
Quality of Life Measured using Knee Injury and Osteoarthritis Outcome Score Quality of Life (KOOS QOL)
Time frame: 1-, 3-, and 6-month visits
Quality of Life Measured using Patient Reported Outcome Measurement Information System (PROMIS) Global 10
Time frame: 1-, 3-, and 6-month visits
Walk Test
Time frame: 1-, 3-, and 6-month visits
Chair Stand Test
Time frame: 1-, 3-, and 6-month visits
Daily Step Count
Time frame: 1-, 3-, and 6-month visits
Incidence of Pain Medication use
Time frame: 1-, 3-, and 6-month visits
Gait Analysis
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Knee Pain
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VR and Cooled Genicular Nerve Radio Frequency Ablation for Chronic Knee Pain
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy E McAlindon, MD, MPH principal investigator
UMass Worcester (UMass Chan Medical School)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency Ablation in people with Chronic Knee Pain, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability by actively treated participants Outcome (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.