Osteoarthritis, KneeNCT06017674
Intra-articular Pulsed Radiofrequency in Chronic Knee Pain
A study testing Intra-articular Pulsed Radiofrequency and Steroid Injection in people with Osteoarthritis, Knee and Osteoarthritis, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the additional effect of Intra-articular Pulsed Radiofrequency (IAPRF) on pain and functional activities in addition to intra-articular steroids in patients with grade II and III knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis, Pain, Chronic
- What is being tested?
- Intra-articular Pulsed Radiofrequency and Steroid Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 31 Dec 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years,
- Having knee pain persisting for more than 3 months due to knee osteoarthritis (OA),
- Kellgren-Lawrence Classification grades II and III OA,
- Giving written and verbal informed consents.
Who cannot join
- Patients with a history of undergoing knee surgery and/or receiving any intra-articular knee injection within the previous 6 months,
- Having a local or systemic infection or a coagulation disorder,
- Patients who refused to participate in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Başakşehir Cam and Sakura Şehir Hospital
Istanbul, 34488
About this study
Official title: The Effectiveness of Intra-articular Pulsed Radiofrequency in Patients With Painful Knee Osteoarthritis
The aim of this study is to investigate the additional effect of Intra-articular Pulsed Radiofrequency (IAPRF) on pain and functional activities in addition to intra-articular steroids in patients with grade II and III knee osteoarthritis.
Read the detailed description
This randomized controlled trial included patients over 18 years of age with knee pain persisting for more than 3 months and stage II-III knee OA according to the Kellgren-Lawrence scale. The participants were randomized into two groups: the IAPRF + steroid injection (Group 1) and only steroid injection (Group 2) groups. The injections were administered under fluoroscopic guidance in both groups, and the needle was advanced to the midline of the tibiofemoral joint in the anteroposterior and lateral views. Group 1 received 8 mg of intra-articular dexamethasone after IAPRF application for 360 s at 45 V voltage, with the temperature not exceeding 42°C. Group 2 received 8 mg of intra-articular dexamethasone only. Pain intensity and participation in daily activities were evaluated using the numerical rating scale (NRS) and Western Ontario and McMaster Universities arthritis index (WOMAC), respectively, before the procedure and 1, 4, and 12 weeks after the procedure.
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Pain, Chronic
- Being tested
- Intra-articular Pulsed Radiofrequency, Steroid Injection
- Keywords
- intra-articular pulsed radiofrequency, knee osteoarthritis, intra-articular steroid injection
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular Pulsed RadiofrequencyProcedure or surgery
A 22-gauge 10 cm radiofrequency cannula with a 10-mm active tip was advanced to the mid-tibiofemoral joint under fluoroscopic guidance. After needle insertion, paresthesia-pain and motor stimulation tests were performed using sensory (50 Hz) and motor (2 Hz, 1 V) stimulation to confirm the absence of stimulation. Intra-articular Pulsed Radiofrequency (IAPRF) was applied at 45 V voltage for 20 ms pulse width for 360 s, followed by a 480 ms silent phase. The tissue temperature was adjusted to not exceed 42°C.
Steroid InjectionDrug
8 mg dexamethasone was applied into the tibio-femoral joint with a 22-gauge, 10 cm needle under fluoroscopy.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Intra-articular Pulsed Radiofrequency and Steroid Injection Receives: Procedure: Intra-articular Pulsed Radiofrequency; Drug: Steroid Injection |
| Group 2 | Experimental | Only Intra-articular Steroid Injection Receives: Drug: Steroid Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale
Pain levels before and 1, 4, 12 weeks after the procedure were evaluated with Numeric Rating Scale (NRS). The patients were instructed to score their pain intensity on a scale of 0 to 10, where "0" represents "no pain at all" and "10" represents "worst pain ever possible."
Measured: 0, 1, 4 and 12 weeks
Secondary outcomes (1)
Western Ontario and McMaster Universities Arthritis Index
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) was used to assess daily living activities at all evaluation points.The WOMAC consists of 24 items on three subscales: pain, stiffness, and physical function. All items were scored on a scale of 0 to 4, where "0" represents none, "1" represents mild, "2" represents moderate, "3" represents severe, and "4" represents extreme. The total score ranges from 0 to 96, with a higher score indicating poorer function in daily living activities.
Measured: 0, 1, 4 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start1 May 2022
- Primary completion30 Sep 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies 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
- Single-center, single-blinded, randomized prospective trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Burak Erken, Başakşehir Çam & Sakura City Hospital
- Investigators
- Burak Erken, MD, Principal investigator, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017674
- Sponsor's protocol ID
- 2022.03.89
- Status last verified
- Aug 2023
- First submitted
- 24 Aug 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Filippiadis D, Tsochatzis A, Petsatodis E, Galanis S, Velonakis G, Giankoulof C, Kelekis A. Intra-Articular Application of Sluijter-Teixera Poisson Pulsed Radiofrequency in Symptomatic Patients with Knee Osteoarthritis: Focus upon Clinical Efficacy and Safety. Pain Res Manag. 2021 Feb 20;2021:5554631. doi: 10.1155/2021/5554631. eCollection 2021.
PubMed 34518775Masala S, Fiori R, Raguso M, Morini M, Calabria E, Simonetti G. Pulse-dose radiofrequency for knee osteoartrithis. Cardiovasc Intervent Radiol. 2014 Apr;37(2):482-7. doi: 10.1007/s00270-013-0694-z. Epub 2013 Aug 14.
PubMed 23942592Karaman H, Tufek A, Kavak GO, Yildirim ZB, Uysal E, Celik F, Kaya S. Intra-articularly applied pulsed radiofrequency can reduce chronic knee pain in patients with osteoarthritis. J Chin Med Assoc. 2011 Aug;74(8):336-40. doi: 10.1016/j.jcma.2011.06.004. Epub 2011 Jul 23.
PubMed 21872812Sluijter ME, Teixeira A, Serra V, Balogh S, Schianchi P. Intra-articular application of pulsed radiofrequency for arthrogenic pain--report of six cases. Pain Pract. 2008 Jan-Feb;8(1):57-61. doi: 10.1111/j.1533-2500.2007.00172.x. No abstract available.
PubMed 18211593
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Intra-articular Pulsed Radiofrequency in Patients With Painful Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06017674
- Acronym / sponsor ID
- 2022.03.89
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Pain, Chronic
- Keywords
- intra-articular pulsed radiofrequency, knee osteoarthritis, intra-articular steroid injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 30 Aug 2023 (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 aim of this study is to investigate the additional effect of Intra-articular Pulsed Radiofrequency (IAPRF) on pain and functional activities in addition to intra-articular steroids in patients with grade II and III knee osteoarthritis.
Detailed description
This randomized controlled trial included patients over 18 years of age with knee pain persisting for more than 3 months and stage II-III knee OA according to the Kellgren-Lawrence scale. The participants were randomized into two groups: the IAPRF + steroid injection (Group 1) and only steroid injection (Group 2) groups. The injections were administered under fluoroscopic guidance in both groups, and the needle was advanced to the midline of the tibiofemoral joint in the anteroposterior and lateral views. Group 1 received 8 mg of intra-articular dexamethasone after IAPRF application for 360 s at 45 V voltage, with the temperature not exceeding 42°C. Group 2 received 8 mg of intra-articular dexamethasone only. Pain intensity and participation in daily activities were evaluated using the numerical rating scale (NRS) and Western Ontario and McMaster Universities arthritis index (WOMAC), respectively, before the procedure and 1, 4, and 12 weeks after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Single-center, single-blinded, randomized prospective trial
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Procedure: Intra-articular Pulsed Radiofrequency, Drug: Steroid InjectionIntra-articular Pulsed Radiofrequency and Steroid Injection |
| Group 2 | Experimental | Drug: Steroid InjectionOnly Intra-articular Steroid Injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years,
- Having knee pain persisting for more than 3 months due to knee osteoarthritis (OA),
- Kellgren-Lawrence Classification grades II and III OA,
- Giving written and verbal informed consents.
Key exclusion criteria (3 listed)
- Patients with a history of undergoing knee surgery and/or receiving any intra-articular knee injection within the previous 6 months,
- Having a local or systemic infection or a coagulation disorder,
- Patients who refused to participate in the study.
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 |
|---|---|---|
| Intra-articular Pulsed RadiofrequencyA 22-gauge 10 cm radiofrequency cannula with a 10-mm active tip was advanced to the mid-tibiofemoral joint under fluoroscopic guidance. After needle insertion, paresthesia-pain and motor stimulation tests were performed using sensory (50 Hz) and motor (2 Hz, 1 V) stimulation to confirm the absence of stimulation. Intra-articular Pulsed Radiofrequency (IAPRF) was applied at 45 V voltage for 20 ms pulse width for 360 s, followed by a 480 ms silent phase. The tissue temperature was adjusted to not exceed 42°C. | Procedure or surgery | Group 1 |
| Steroid Injection8 mg dexamethasone was applied into the tibio-femoral joint with a 22-gauge, 10 cm needle under fluoroscopy. | Drug | Group 1, Group 2 |
Primary outcome
Numeric Rating Scale
Time frame: 0, 1, 4 and 12 weeks
Pain levels before and 1, 4, 12 weeks after the procedure were evaluated with Numeric Rating Scale (NRS). The patients were instructed to score their pain intensity on a scale of 0 to 10, where "0" represents "no pain at all" and "10" represents "worst pain ever possible."
1 secondary outcome
Western Ontario and McMaster Universities Arthritis Index
Time frame: 0, 1, 4 and 12 weeks
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 Aug 2023.
- Results publication: PubMed 34518775Filippiadis D, Tsochatzis A, Petsatodis E, Galanis S, Velonakis G, Giankoulof C, Kelekis A. Intra-Articular Application of Sluijter-Teixera Poisson Pulsed Radiofrequency in Symptomatic Patients with Knee Osteoarthritis: Focus upon Clinical Efficacy and Safety. Pain Res Manag. 2021 Feb 20;2021:5554631. doi: 10.1155/2021/5554631. eCollection 2021.
- Results publication: PubMed 23942592Masala S, Fiori R, Raguso M, Morini M, Calabria E, Simonetti G. Pulse-dose radiofrequency for knee osteoartrithis. Cardiovasc Intervent Radiol. 2014 Apr;37(2):482-7. doi: 10.1007/s00270-013-0694-z. Epub 2013 Aug 14.
- Results publication: PubMed 21872812Karaman H, Tufek A, Kavak GO, Yildirim ZB, Uysal E, Celik F, Kaya S. Intra-articularly applied pulsed radiofrequency can reduce chronic knee pain in patients with osteoarthritis. J Chin Med Assoc. 2011 Aug;74(8):336-40. doi: 10.1016/j.jcma.2011.06.004. Epub 2011 Jul 23.
- Results publication: PubMed 18211593Sluijter ME, Teixeira A, Serra V, Balogh S, Schianchi P. Intra-articular application of pulsed radiofrequency for arthrogenic pain--report of six cases. Pain Pract. 2008 Jan-Feb;8(1):57-61. doi: 10.1111/j.1533-2500.2007.00172.x. No abstract available.
- Individual participant dataSharing planned: No
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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.
Burak Erken, MD principal investigator
Başakşehir Çam & Sakura City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-articular Pulsed Radiofrequency and Steroid Injection in people with Osteoarthritis, Knee and Osteoarthritis, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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 Aug 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 Turkey (Türkiye). 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. 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?
Numeric Rating Scale (time frame: 0, 1, 4 and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06017674, which also lists 4 linked publications.
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 Aug 2023.