Knee OsteoarthritisNCT04238598
Intra-articular Pulsed Radiofrequency Neuromodulation Versus Intra-articular Steroids for Painful Knee Osteoarthritis
A study testing Pulse Radiofrequency in people with Knee Osteoarthritis, run by Center For Interventional Pain and Spine at 1 site in United States.
Trial summary
To compare the efficacy of intra-articular pulsed radiofrequency to intra-articular steroids in patients with moderate-severe painful osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Pulse Radiofrequency
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2019to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Capable of giving written informed consent
- Patients aged 18 years or older
- Patients with unilateral or bilateral knee pain for at least 3 months
- Radiographic evidence of knee osteoarthritis
- Appropriate candidate for steroid injection as determined by the investigator
Who cannot join
- Chronic knee pain caused by infection, inflammation, tumors, and fractures
- A history of acute knee pain, previous knee surgery, connective tissue diseases, progressive neurologic disease or uncontrolled psychiatric disorders
- The administration of steroids or hyaluronic acids within the last three months
- Coagulation disorders
- Local infection at the site of intervention planned
- Active litigation related to this pain complaint
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Interventional Pain and Spine
Exton, Pennsylvania, 19341
About this study
Official title: Sham-controlled Randomized Trial of Intra-articular Pulsed Radiofrequency Neuromodulation Versus Intra-articular Steroids for Painful Knee Osteoarthritis
To compare the efficacy of intra-articular pulsed radiofrequency to intra-articular steroids in patients with moderate-severe painful osteoarthritis of the knee.
Read the detailed description
Patients Adult patients with intractable knee pain for more than 6 months and radiographic evidence of grade II, III or IV knee osteoarthritis. Must not have had a knee injection or other interventional procedure for knee pain within the past 12 weeks. Must be on stable medications for the past 12 weeks and willing to keep medications stable for the first 12 weeks of the study.
Study Design Pilot study will enroll 30 patients randomized 1:1:1.
- Active control - intra-articular 4 milliliters 0.5% bupivacaine + 10mg dexamethasone + sham Pulsed Radiofrequency
- Placebo control - intra-articular 5 milliliters 0.9% saline + sham Pulsed Radiofrequency
- Treatment group - intra-articular 5 milliliters 0.5% bupivacaine + Pulsed Radiofrequency
Methods Two 18-gauge radiofrequency needle with 10 millimeter active tip will be placed intra-articularly from an anterolateral and anteromedial approach to target the medial and lateral compartments. Once satisfactory fluoroscopic placement is noted, the Pulsed Radiofrequency or sham-Pulsed Radiofrequency treatment will be administered. Subsequently, the injectate will be administered. Dexamethasone is selected as the corticosteroid as it is colorless and will be indistinguishable from the saline used in the Intra-articular Pulsed Radiofrequency and placebo groups.
- Conditions
- Knee Osteoarthritis
- Being tested
- Pulse Radiofrequency, Standard of Care Intra- Articular Injection, Placebo Intra-Articular Injection
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse RadiofrequencyProcedure or surgery
Two 20-gauge radiofrequency needle with 10mm active tip will be placed intra-articularly from an anterolateral and anteromedial approach to target the medial and lateral compartments. Once satisfactory fluoroscopic placement is noted, the Pulsed Radiofrequency treatment will be administered.
Standard of Care Intra- Articular InjectionProcedure or surgery
Two 20-gauge radiofrequency needle with 10mm active tip will be placed intra-articularly from an anterolateral and anteromedial approach to target the medial and lateral compartments. Once satisfactory fluoroscopic placement is noted, the Intra-Articular treatment will be administered.
Placebo Intra-Articular InjectionProcedure or surgery
Two 20-gauge radiofrequency needle with 10mm active tip will be placed intra-articularly from an anterolateral and anteromedial approach to target the medial and lateral compartments. Once satisfactory fluoroscopic placement is noted, the Placebo Intra-Articular treatment will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | intra-articular 4 milliliters 0.5% bupivacaine + 10mg dexamethasone + sham Pulsed Radiofrequency Receives: Procedure: Placebo Intra-Articular Injection |
| Control | Placebo comparator | intra-articular 5 milliliters 0.9% saline + sham Pulsed Radiofrequency Receives: Procedure: Standard of Care Intra- Articular Injection |
| Experimental | Experimental | intra-articular 5 milliliters 0.5% bupivacaine + Pulsed Radiofrequency Receives: Procedure: Pulse Radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analogue Scale pain scores
Evaluates the level of pain. Minimum=0 Maximum=10, Larger number indicates worse outcome
Measured: 1-week, 1-, 3-, 6-, and 12-months
Secondary outcomes (4)
Change in Patient-Reported Outcomes Measurement Information System-29 and Western Ontario and McMaster Universities Osteoarthritis (Index)
Evaluates level of pain. For Patient-Reported Outcomes Measurement Information System-29, Minimum= 8 and Maximum=40. For Western Ontario and McMaster Universities Osteoarthritis (Index), Minimum=0 Maximum=20. Larger number indicates worse outcome
Measured: 1-week, 1-, 3-, 6-, and 12-months
Change in Analgesic use
Evaluates number of medications, doses of medications
Measured: 1-week, 1-, 3-, 6-, and 12-months
Change in Timed Up and Go Test
Evaluates physical mobility
Measured: 1-week, 1-, 3-, 6-, and 12-months
Change in Progression to Surgery
Evaluates effectiveness of treatment
Measured: 1-week, 1-, 3-, 6-, and 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start8 Oct 2019
- Primary completion19 Jan 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- Model description
- test, active, control
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center For Interventional Pain and Spine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael A Fishman, MD, Principal investigator, Center For Interventional Pain and Spine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238598
- Sponsor's protocol ID
- 2019IA-PRF
- Status last verified
- Mar 2023
- First submitted
- 25 Oct 2019
- Last updated
- 30 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sham-controlled Randomized Trial of Intra-articular Pulsed Radiofrequency Neuromodulation Versus Intra-articular Steroids for Painful Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04238598
- Acronym / sponsor ID
- 2019IA-PRF
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Center For Interventional Pain and SpineUniversity, hospital or other
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 19 Jan 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 23 Jan 2020 (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.
To compare the efficacy of intra-articular pulsed radiofrequency to intra-articular steroids in patients with moderate-severe painful osteoarthritis of the knee.
Detailed description
Patients Adult patients with intractable knee pain for more than 6 months and radiographic evidence of grade II, III or IV knee osteoarthritis. Must not have had a knee injection or other interventional procedure for knee pain within the past 12 weeks. Must be on stable medications for the past 12 weeks and willing to keep medications stable for the first 12 weeks of the study.
Study Design Pilot study will enroll 30 patients randomized 1:1:1.
- Active control - intra-articular 4 milliliters 0.5% bupivacaine + 10mg dexamethasone + sham Pulsed Radiofrequency
- Placebo control - intra-articular 5 milliliters 0.9% saline + sham Pulsed Radiofrequency
- Treatment group - intra-articular 5 milliliters 0.5% bupivacaine + Pulsed Radiofrequency
Methods Two 18-gauge radiofrequency needle with 10 millimeter active tip will be placed intra-articularly from an anterolateral and anteromedial approach to target the medial and lateral compartments. Once satisfactory fluoroscopic placement is noted, the Pulsed Radiofrequency or sham-Pulsed Radiofrequency treatment will be administered. Subsequently, the injectate will be administered. Dexamethasone is selected as the corticosteroid as it is colorless and will be indistinguishable from the saline used in the Intra-articular Pulsed Radiofrequency and placebo groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- test, active, control
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Procedure: Placebo Intra-Articular Injectionintra-articular 4 milliliters 0.5% bupivacaine + 10mg dexamethasone + sham Pulsed Radiofrequency |
| Control | Placebo comparator | Procedure: Standard of Care Intra- Articular Injectionintra-articular 5 milliliters 0.9% saline + sham Pulsed Radiofrequency |
| Experimental | Experimental | Procedure: Pulse Radiofrequencyintra-articular 5 milliliters 0.5% bupivacaine + Pulsed Radiofrequency |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Capable of giving written informed consent
- Patients aged 18 years or older
- Patients with unilateral or bilateral knee pain for at least 3 months
- Radiographic evidence of knee osteoarthritis
- Appropriate candidate for steroid injection as determined by the investigator
Key exclusion criteria (6 listed)
- Chronic knee pain caused by infection, inflammation, tumors, and fractures
- A history of acute knee pain, previous knee surgery, connective tissue diseases, progressive neurologic disease or uncontrolled psychiatric disorders
- The administration of steroids or hyaluronic acids within the last three months
- Coagulation disorders
- Local infection at the site of intervention planned
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 |
|---|---|---|
| Pulse RadiofrequencyTwo 20-gauge radiofrequency needle with 10mm active tip will be placed intra-articularly from an anterolateral and anteromedial approach to target the medial and lateral compartments. Once satisfactory fluoroscopic placement is noted, the Pulsed Radiofrequency treatment will be administered. | Procedure or surgery | Experimental |
| Standard of Care Intra- Articular InjectionTwo 20-gauge radiofrequency needle with 10mm active tip will be placed intra-articularly from an anterolateral and anteromedial approach to target the medial and lateral compartments. Once satisfactory fluoroscopic placement is noted, the Intra-Articular treatment will be administered. | Procedure or surgery | Control |
| Placebo Intra-Articular InjectionTwo 20-gauge radiofrequency needle with 10mm active tip will be placed intra-articularly from an anterolateral and anteromedial approach to target the medial and lateral compartments. Once satisfactory fluoroscopic placement is noted, the Placebo Intra-Articular treatment will be administered. | Procedure or surgery | Active |
Primary outcome
Change in Visual Analogue Scale pain scores
Time frame: 1-week, 1-, 3-, 6-, and 12-months
Evaluates the level of pain. Minimum=0 Maximum=10, Larger number indicates worse outcome
4 secondary outcomes
Change in Patient-Reported Outcomes Measurement Information System-29 and Western Ontario and McMaster Universities Osteoarthritis (Index)
Time frame: 1-week, 1-, 3-, 6-, and 12-months
Change in Analgesic use
Time frame: 1-week, 1-, 3-, 6-, and 12-months
Change in Timed Up and Go Test
Time frame: 1-week, 1-, 3-, 6-, and 12-months
Change in Progression to Surgery
Time frame: 1-week, 1-, 3-, 6-, and 12-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
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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.
Michael A Fishman, MD principal investigator
Center For Interventional Pain and Spine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse Radiofrequency in people with Knee Osteoarthritis, run by Center For Interventional Pain and Spine 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 30 Mar 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Visual Analogue Scale pain scores (time frame: 1-week, 1-, 3-, 6-, and 12-months). 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 30 Mar 2023.