Knee OsteoarthritisNCT05303766
Radiofrequency Ablation in the Pain Management of Knee Osteoarthritis
A study testing Radio-frequency ablation, Intra-articular steroids and Pulsed Radio-frequency in people with Knee Osteoarthritis, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of this study is to assess the safety and efficacy of radio frequency thermo-coagulation on the genicular nerve (RFTGN) and intra-articular pulsed radio frequency (IAPRF) for Knee Osteoarthritis (KOA) to improve physical activity , range of joint movement , pain intensity and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Radio-frequency ablation, Intra-articular steroids and Pulsed Radio-frequency
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2022to Mar 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients diagnosed with KOA based on the American College of Rheumatology criteria
- age 18-70 years
- grade 2 or 3 KOA based on the Kellgren-Lawrence classification
- patients who did not respond to conservative treatment (physiotherapy, oral NSAIDs, and/or intraarticular injections of hyaluronic acid and corticosteroid) for 3 months
- duration of knee pain ≥ 3 months
- numeric rating scale (NRS) ≥ 5 points within 24 h prior to admission.
Who cannot join
- grade 1 or 4 KOA based on the Kellgren-Lawrence classification
- severe liver, kidney, cardiovascular, and respiratory disease
- abnormal blood coagulation
- skin infections in the puncture region
- patients who previously underwent knee arthroscopy, TKA, RFTGN, or IAPRF
- mental disorders or inability to complete the follow-up observational form
- patients with bilateral knee pain.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Safety and Effectiveness of Radiofrequency Thermocoagulation on Genicular Nerve, Intraarticular Pulsed Radiofrequency With Steroid Injection in the Pain Management of Knee Osteoarthritis
The aim of this study is to assess the safety and efficacy of radio frequency thermo-coagulation on the genicular nerve (RFTGN) and intra-articular pulsed radio frequency (IAPRF) for Knee Osteoarthritis (KOA) to improve physical activity , range of joint movement , pain intensity and quality of life.
Read the detailed description
After obtaining the consent from patients and being informed about the study and potential risks , all patients were randomly assigned to the RFTGN, IAPRF, and intraarticular steroid injection (IAS) groups. All procedures were performed under the guidance of C-arm X-ray machine. The observation indicators of this study were the numeric rating scale (NRS), Oxford knee scale (OKS), and perceived global effect (GPE). The time points for the assessment were 1-week, 1-month, 3-months, 6-months and 9-months after the treatment.
- Conditions
- Knee Osteoarthritis
- Being tested
- Radio-frequency ablation, Intra-articular steroids, Pulsed Radio-frequency
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radio-frequency ablationDevice
Also called Radiofrequency generator
Radiofrequency thermocoagulation of the genicular nerves
Intra-articular steroidsDrug
Also called Betafos®
Intra-articular steroids for Knee osteoarthritis
Pulsed Radio-frequencyDevice
Also called Radiofrequency generator
Intraarticular Pulsed Radiofrequency of the knee
| Study group | Role | What they receive |
|---|---|---|
| RFT group | Experimental | The treatment of the patients in the radio frequency thermo-coagulation of the genicular nerves was conducted under the guidance of C-arm X-ray machine . The C-arm machine showed that the radiofrequency cannula needle was advanced percutaneously towards the periosteal areas connecting the shaft of the femur to bilateral epicondyles and the shaft of the tibia to the medial epicondyle while the lateral image showed that the depth of the needle insertion was about 50% of the diameter of the femur or tibia. The radiofrequency electrodes were connected and tested. These induced abnormal pain around the knee joint at 50 Hz and 0.1-0.3 V, but did not induce contraction of the muscles of the knee joint at 2 Hz and > 2.0 V. The location of the needle tip was confirmed by the C-arm, and 0.5 mL of 1% lidocaine was used for local anesthesia. The temperature of RFT was increased gradually to 70°C for 180 seconds. Receives: Device: Radio-frequency ablation |
| IAPRF group | Experimental | The puncture site was selected in the middle of the medial or lateral edge of the patella. After local anesthesia was administered with 0.5% lidocaine, the radiofrequency cannula needle was inserted slowly between the patella and femoral condyles. The needle was gradually inserted into the joint cavity, and then a small volume of saline was administered using a syringe. If any resistance was encountered, which indicated that the needle tip was located in a ligament or tendon, the surgeon readjusted the needle tip until the injection proceeded without any significant resistance. After entering the joint cavity, the C-arm x-ray is used confirm that the cannula needle was located in the middle of the joint space. Subsequently, sensory stimulation using 50 Hz/2 Hz was performed at > 2 V, to prevent inducing pain or muscle contraction. Then, an automatic PRF mode ≤ 45 V (≤ 42°C, 2 Hz, pulse width of 20 ms) was administered for 300 seconds. Receives: Device: Pulsed Radio-frequency |
| IAS group | Experimental | The puncture procedure was similar to that for the IAPRF group. After the cannula needle was inserted to the articular cavity, 1 mL compound betamethasone (2 mg betamethasone sodium phosphate and 5 mg betamethasone dipropionate) was injected. Then, the needle was withdrawn, and the puncture site was dressed aseptically. Receives: Drug: Intra-articular steroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating scale (NRS)
Using the numerical rating score , a score from ( 0 to 10 ) for evaluation of pain intensity. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Measured: 9 months and after procedure
Oxford Knee Score
Using oxford knee score for follow up of pain of knee osteoarthritis , a score from 0 to 48 . if the score is 0 to 19 this may indicate sever arthritis , and if it's from 40 to 48 it means satisfactory joint function . This scrore is based on a 12-question report about an individual's level of function, activities of daily living and how they have been affected by pain over the preceding four weeks.
Measured: 9 months and after procedure
Secondary outcomes (4)
Duration of pain free periods
Duration of pain free periods since the intervention has been done
Measured: 9 months and after procedure
Site of pain
Patients undergo physical knee examination to determine the site of knee pain at right or left knee , medial or lateral joint line
Measured: 9 months and after procedure
Total consumption of analgesics ( e.g NSAIDS , weak opioids… ect )
Different analgesics used by the patients to alleviate the pain. The patient is asked about how frequent he/she uses an analgesic for pain relief.
Measured: 9 months and after procedure
Improvement of knee joint function
Using The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for evaluation of knee osteoarthritis. t is a self-administered questionnaire consisting of 24 items divided into 3 subscales: 1- Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright.
2-Stiffness (2 items): after first waking and later in the day. 3- Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties.
Measured: 9 months and after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study startApr 2022 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
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.
- More trials run by Assiut UniversityThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Mostafa Ali Osman, Assiut University
- Investigators
- Esraa M Osman, MBBCH, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303766
- Sponsor's protocol ID
- Radiofrequency Ablation KOA
- Status last verified
- Apr 2022
- First submitted
- 26 Jan 2022
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD to be shared
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Safety and Effectiveness of Radiofrequency Thermocoagulation on Genicular Nerve, Intraarticular Pulsed Radiofrequency With Steroid Injection in the Pain Management of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05303766
- Acronym / sponsor ID
- Radiofrequency Ablation KOA
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 31 Mar 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 aim of this study is to assess the safety and efficacy of radio frequency thermo-coagulation on the genicular nerve (RFTGN) and intra-articular pulsed radio frequency (IAPRF) for Knee Osteoarthritis (KOA) to improve physical activity , range of joint movement , pain intensity and quality of life.
Detailed description
After obtaining the consent from patients and being informed about the study and potential risks , all patients were randomly assigned to the RFTGN, IAPRF, and intraarticular steroid injection (IAS) groups. All procedures were performed under the guidance of C-arm X-ray machine. The observation indicators of this study were the numeric rating scale (NRS), Oxford knee scale (OKS), and perceived global effect (GPE). The time points for the assessment were 1-week, 1-month, 3-months, 6-months and 9-months after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RFT group | Experimental | Device: Radio-frequency ablationThe treatment of the patients in the radio frequency thermo-coagulation of the genicular nerves was conducted under the guidance of C-arm X-ray machine . The C-arm machine showed that the radiofrequency cannula needle was advanced percutaneously towards the periosteal areas connecting the shaft of the femur to bilateral epicondyles and the shaft of the tibia to the medial epicondyle while the lateral image showed that the depth of the needle insertion was about 50% of the diameter of the femur or tibia. The radiofrequency electrodes were connected and tested. These induced abnormal pain around the knee joint at 50 Hz and 0.1-0.3 V, but did not induce contraction of the muscles of the knee joint at 2 Hz and > 2.0 V. The location of the needle tip was confirmed by the C-arm, and 0.5 mL of 1% lidocaine was used for local anesthesia. The temperature of RFT was increased gradually to 70°C for 180 seconds. |
| IAPRF group | Experimental | Device: Pulsed Radio-frequencyThe puncture site was selected in the middle of the medial or lateral edge of the patella. After local anesthesia was administered with 0.5% lidocaine, the radiofrequency cannula needle was inserted slowly between the patella and femoral condyles. The needle was gradually inserted into the joint cavity, and then a small volume of saline was administered using a syringe. If any resistance was encountered, which indicated that the needle tip was located in a ligament or tendon, the surgeon readjusted the needle tip until the injection proceeded without any significant resistance. After entering the joint cavity, the C-arm x-ray is used confirm that the cannula needle was located in the middle of the joint space. Subsequently, sensory stimulation using 50 Hz/2 Hz was performed at > 2 V, to prevent inducing pain or muscle contraction. Then, an automatic PRF mode ≤ 45 V (≤ 42°C, 2 Hz, pulse width of 20 ms) was administered for 300 seconds. |
| IAS group | Experimental | Drug: Intra-articular steroidsThe puncture procedure was similar to that for the IAPRF group. After the cannula needle was inserted to the articular cavity, 1 mL compound betamethasone (2 mg betamethasone sodium phosphate and 5 mg betamethasone dipropionate) was injected. Then, the needle was withdrawn, and the puncture site was dressed aseptically. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
Key exclusion criteria (7 listed)
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 |
|---|---|---|
| Radio-frequency ablationAlso: Radiofrequency generatorRadiofrequency thermocoagulation of the genicular nerves | Device | RFT group |
| Intra-articular steroidsAlso: Betafos®Intra-articular steroids for Knee osteoarthritis | Drug | IAS group |
| Pulsed Radio-frequencyAlso: Radiofrequency generatorIntraarticular Pulsed Radiofrequency of the knee | Device | IAPRF group |
Primary outcome
Numeric rating scale (NRS)
Time frame: 9 months and after procedure
Using the numerical rating score , a score from ( 0 to 10 ) for evaluation of pain intensity. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Oxford Knee Score
Time frame: 9 months and after procedure
Using oxford knee score for follow up of pain of knee osteoarthritis , a score from 0 to 48 . if the score is 0 to 19 this may indicate sever arthritis , and if it's from 40 to 48 it means satisfactory joint function . This scrore is based on a 12-question report about an individual's level of function, activities of daily living and how they have been affected by pain over the preceding four weeks.
4 secondary outcomes
Duration of pain free periods
Time frame: 9 months and after procedure
Site of pain
Time frame: 9 months and after procedure
Total consumption of analgesics ( e.g NSAIDS , weak opioids… ect )
Time frame: 9 months and after procedure
Improvement of knee joint function
Time frame: 9 months and after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Individual participant dataSharing planned: Yes. all collected IPD to be shared
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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.
Esraa M Osman, MBBCH principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radio-frequency ablation, Intra-articular steroids and Pulsed Radio-frequency in people with Knee Osteoarthritis, run by Assiut University at 1 site in Egypt.
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 7 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: status not confirmed, as of the sponsor's last update on 13 Apr 2022. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Golnar Mohamed Fathy (01009160566, Golnar_fathy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric rating scale (NRS) (time frame: 9 months and after procedure). The study lists 2 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 13 Apr 2022.