Knee OsteoarthritisNCT05202847
Clinial Application of Park et al.(The Knee 27 (2020) 1577-1584)'s Study
A study testing pulsed radiofrequency ablation to modifined points group and pulsed radiofrequency ablation to conventional points group in people with Knee Osteoarthritis, run by Gangnam Severance Hospital.
Trial summary
The goal of this study was to perform pulsed radiofrequency ablation with a modified target suggested in the cadaver study by Park et al. (The Knee 27 (2020) 1577-1584) on knee osteoarthritis patients, and to evaluate the effect of reducing the frequency of intravascular injection and reducing pain. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- pulsed radiofrequency ablation to modifined points group and pulsed radiofrequency ablation to conventional points group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 7 Dec 2022to 7 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic knee pain that does not respond to conservative treatment (physiotherapy, oral analgesic, steroid intra-articular injection, Hyruan injection) for more than 6 months
- A score of 6 or higher (out of 10) on the target knee's numerical rating scale
- Knee osteoarthritis 1-4 confirmed in knee X ray within 6 months of study enrollment
Who cannot join
- Systemic inflammatory diseases such as rheumatic diseases
- uncontrolled diabetes
- malignant tumor
- If the target knee has a previous surgical history (arthroscopy, arthroscopy, autologous or allograft osteochondral transplantation and autologous cartilage cell transplantation, osteotomy, arthritis surgery)
- Patients with lidocaine and contrast agent allergy
- history of nerve block in the target knee within 2 weeks
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- Body mass index over 40 kg/m2
- bleeding disorder
- Pregnant/lactating women
- Inability to understand informed consent and respond to research questionnaires due to cognitive impairment
- Unable to read consent form (e.g. illiterate, foreigner, etc.)
About this study
Official title: Pulsed Radiofrequency Ablation to the Modified Ablation Points for Chronic Knee Pain Due to Osteoarthritis: Preliminary Prospective Randomized Controlled Study
The goal of this study was to perform pulsed radiofrequency ablation with a modified target suggested in the cadaver study by Park et al. (The Knee 27 (2020) 1577-1584) on knee osteoarthritis patients, and to evaluate the effect of reducing the frequency of intravascular injection and reducing pain.
- Conditions
- Knee Osteoarthritis
- Being tested
- pulsed radiofrequency ablation to modifined points group, pulsed radiofrequency ablation to conventional points group
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulsed radiofrequency ablation to modifined points groupProcedure or surgery
Point 1 place 10mm higher than the boundary between Femur's medial epicondyle and shaft. The 2nd point is targeted 20mm above the patella. Point 3 is targeted 10mm above the femur lateral epicondyle and shaft boundary. At point 4, find the boundary position between the tibia epicondyle and the shaft in the AP view and move it superolateral by 10 mm to target the central part of the medial shaft of the tibia and perform the main touch. Point 5 targets the center of the fibular head.
pulsed radiofrequency ablation to conventional points groupProcedure or surgery
Under AP view X-ray fluoroscopy, enter the cannula into the tunnel view until reaching the bone, reaching the border of the shaft and epicondyle, then stop the cannula tip at the anterior 2/3 junction in the lateral view. A total of three target points are the boundary position between the femur medial epicondyle and the shaft, the boundary position between the femur lateral epicondyle and the shaft, and the boundary position between the tibia meidal epiconcyle and the shaft. Subsequent procedure will be proceed same as Arm 1
| Study group | Role | What they receive |
|---|---|---|
| pulsed radiofrequency ablation to modified points group | Experimental | pulsed radiofrequency ablation aimed at the adjusted target point of Park et al. under C-arm guidance Receives: Procedure: pulsed radiofrequency ablation to modifined points group |
| pulsed radiofrequency ablation to conventional points group | Active comparator | pulsed radiofrequency ablation aimed at conventional target point under C-arm guidance Receives: Procedure: pulsed radiofrequency ablation to conventional points group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate at which vascular uptake is confirmed when the first contrast agent is given after the needle is positioned at the target point
Whether vascular uptake is confirmed on the x-ray image is a binary response.
Measured: during the ablation procedure
Secondary outcomes (4)
numeric rating score
A score of 0 indicates no pain and a score of 10 indicates maximum pain.
Measured: Before the pulsed radiofrequency ablation, after 4 weeks of the ablaion, after 8 weeks of the ablation, after 12 weeks of the ablation
functional status
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints
Measured: Before the pulsed radiofrequency ablation, after 4 weeks of the ablaion, after 8 weeks of the ablation, after 12 weeks of the ablation
quality of life
Q-5D is a standardised measure of health-related quality of life developed by the EuroQol Group to provide a simple, generic questionnaire for use in clinical and economic appraisal and population health surveys.
Measured: Before the pulsed radiofrequency ablation, after 4 weeks of the ablaion, after 8 weeks of the ablation, after 12 weeks of the ablation
medication
The Medication Quantification Scale (MQS) is an instrument with potential clinical and research applications for quantifying medication regimen use in chronic pain populations.
Measured: Before the pulsed radiofrequency ablation, after 4 weeks of the ablaion, after 8 weeks of the ablation, after 12 weeks of the ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start7 Dec 2022
- Primary completion7 Dec 2022
- Study completion7 Dec 2022
Why it stopped: difficulties in recruiting patients with knee osteoarthritis to the pain clinic.
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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Yeong Kim, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202847
- Sponsor's protocol ID
- 3-2021-0432
- Status last verified
- Jun 2023
- First submitted
- 10 Jan 2022
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Radiofrequency Ablation to the Modified Ablation Points for Chronic Knee Pain Due to Osteoarthritis: Preliminary Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05202847
- Acronym / sponsor ID
- 3-2021-0432
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: difficulties in recruiting patients with knee osteoarthritis to the pain clinic.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 7 Dec 2022 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 7 Dec 2022 (actual)
- First posted
- 24 Jan 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 goal of this study was to perform pulsed radiofrequency ablation with a modified target suggested in the cadaver study by Park et al. (The Knee 27 (2020) 1577-1584) on knee osteoarthritis patients, and to evaluate the effect of reducing the frequency of intravascular injection and reducing pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pulsed radiofrequency ablation to modified points group | Experimental | Procedure: pulsed radiofrequency ablation to modifined points grouppulsed radiofrequency ablation aimed at the adjusted target point of Park et al. under C-arm guidance |
| pulsed radiofrequency ablation to conventional points group | Active comparator | Procedure: pulsed radiofrequency ablation to conventional points grouppulsed radiofrequency ablation aimed at conventional target point under C-arm guidance |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- chronic knee pain that does not respond to conservative treatment (physiotherapy, oral analgesic, steroid intra-articular injection, Hyruan injection) for more than 6 months
- A score of 6 or higher (out of 10) on the target knee's numerical rating scale
- Knee osteoarthritis 1-4 confirmed in knee X ray within 6 months of study enrollment
Key exclusion criteria (11 listed)
- Systemic inflammatory diseases such as rheumatic diseases
- uncontrolled diabetes
- malignant tumor
- If the target knee has a previous surgical history (arthroscopy, arthroscopy, autologous or allograft osteochondral transplantation and autologous cartilage cell transplantation, osteotomy, arthritis surgery)
- Patients with lidocaine and contrast agent allergy
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 |
|---|---|---|
| pulsed radiofrequency ablation to modifined points groupPoint 1 place 10mm higher than the boundary between Femur's medial epicondyle and shaft. The 2nd point is targeted 20mm above the patella. Point 3 is targeted 10mm above the femur lateral epicondyle and shaft boundary. At point 4, find the boundary position between the tibia epicondyle and the shaft in the AP view and move it superolateral by 10 mm to target the central part of the medial shaft of the tibia and perform the main touch. Point 5 targets the center of the fibular head. | Procedure or surgery | pulsed radiofrequency ablation to modified points group |
| pulsed radiofrequency ablation to conventional points groupUnder AP view X-ray fluoroscopy, enter the cannula into the tunnel view until reaching the bone, reaching the border of the shaft and epicondyle, then stop the cannula tip at the anterior 2/3 junction in the lateral view. A total of three target points are the boundary position between the femur medial epicondyle and the shaft, the boundary position between the femur lateral epicondyle and the shaft, and the boundary position between the tibia meidal epiconcyle and the shaft. Subsequent procedure will be proceed same as Arm 1 | Procedure or surgery | pulsed radiofrequency ablation to conventional points group |
Primary outcome
The rate at which vascular uptake is confirmed when the first contrast agent is given after the needle is positioned at the target point
Time frame: during the ablation procedure
Whether vascular uptake is confirmed on the x-ray image is a binary response.
4 secondary outcomes
numeric rating score
Time frame: Before the pulsed radiofrequency ablation, after 4 weeks of the ablaion, after 8 weeks of the ablation, after 12 weeks of the ablation
functional status
Time frame: Before the pulsed radiofrequency ablation, after 4 weeks of the ablaion, after 8 weeks of the ablation, after 12 weeks of the ablation
quality of life
Time frame: Before the pulsed radiofrequency ablation, after 4 weeks of the ablaion, after 8 weeks of the ablation, after 12 weeks of the ablation
medication
Time frame: Before the pulsed radiofrequency ablation, after 4 weeks of the ablaion, after 8 weeks of the ablation, after 12 weeks of the ablation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing pulsed radiofrequency ablation to modifined points group and pulsed radiofrequency ablation to conventional points group in people with Knee Osteoarthritis, run by Gangnam Severance Hospital.
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 3 inclusion and 11 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: withdrawn, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
The rate at which vascular uptake is confirmed when the first contrast agent is given after the needle is positioned at the target point (time frame: during the ablation procedure). 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 26 Jun 2023.