Knee OsteoarthritisNCT05528965
Parallel Versus Perpendicular Technique for Genicular Radiofrequency
A study testing Perpendicular Group and Parallel Group in people with Knee Osteoarthritis, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Although there are different ways of performing genicular nerve radiofrequency on knee pain, to our knowledge, there is no stuies comparing the clinical outcomes of a parallel technique vs. a perpendicular technique. We aimed to compare the effectiveness of these both techniques. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Perpendicular Group and Parallel Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Sep 2022to 15 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
Who cannot join
- Intra-articular injections in the knee during the 3 months prior to procedure
- Chronic pain syndrome
- Lumbar radicular pain
- Patients who are unwilling or mentally incapable to complete the study questionnaires.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Health Science University Diskapi Yildirim Beyazıt Training and Research Hospital
Yenimahalle, Ankara, 06170
Halil C Kose, MD, +90505 762 86 82, halilcihankose@hotmail.com
About this study
Official title: Parallel Versus Perpendicular Technique for Genicular Radiofrequency Ablation
Although there are different ways of performing genicular nerve radiofrequency on knee pain, to our knowledge, there is no stuies comparing the clinical outcomes of a parallel technique vs. a perpendicular technique. We aimed to compare the effectiveness of these both techniques.
- Conditions
- Knee Osteoarthritis
- Being tested
- Perpendicular Group, Parallel 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.
Perpendicular GroupProcedure or surgery
Radiofrequency ablation was applied to the perpendicular group by placing the tip of electrode perpendicularly to contact the genicular nerves.
Parallel GroupProcedure or surgery
Radiofrequency ablation was applied to the parallel group by placing the electrode lay parallel to contact the genicular nerves.
| Study group | Role | What they receive |
|---|---|---|
| Perpendicular Group | Experimental | Perpendicular genicular radiofrequency application Receives: Procedure: Perpendicular Group |
| Parallel Group | Active comparator | Parallel genicular radiofrequency application Receives: Procedure: Parallel Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with a pain reduction of at least 50% compared to baseline expressed by the numerical rating scale (NRS)
The proportion of patients with a pain reduction of at least 50% compared to baseline expressed by the numerical rating scale (NRS) (0-10).The lower the score, the least pain the patient experiences.
Measured: 6 months after intervention.
Secondary outcomes (1)
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
WOMAC is a 24-item scale under the headings of pain, stiffness and functional activity. Patients rate the amount of strain, pain felt, and joint stiffness during daily activities between 0 and 4 (0 is the best, 4 is the worst), and the total score is between 0 and 96.
Measured: 6 months after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start5 Sep 2022
- Primary completion30 Aug 2023 (estimated)
- Study completion15 Sep 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.
- 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, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halil Cihan Kose, Diskapi Teaching and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528965
- Sponsor's protocol ID
- 139/27
- Status last verified
- Apr 2023
- First submitted
- 1 Sep 2022
- Last updated
- 4 Apr 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 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parallel Versus Perpendicular Technique for Genicular Radiofrequency Ablation
- ClinicalTrials.gov ID
- NCT05528965
- Acronym / sponsor ID
- 139/27
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 15 Sep 2023 (estimated)
- First posted
- 6 Sep 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.
Although there are different ways of performing genicular nerve radiofrequency on knee pain, to our knowledge, there is no stuies comparing the clinical outcomes of a parallel technique vs. a perpendicular technique. We aimed to compare the effectiveness of these both techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perpendicular Group | Experimental | Procedure: Perpendicular GroupPerpendicular genicular radiofrequency application |
| Parallel Group | Active comparator | Procedure: Parallel GroupParallel genicular radiofrequency application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (4 listed)
- Intra-articular injections in the knee during the 3 months prior to procedure
- Chronic pain syndrome
- Lumbar radicular pain
- Patients who are unwilling or mentally incapable to complete the study questionnaires.
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 |
|---|---|---|
| Perpendicular GroupRadiofrequency ablation was applied to the perpendicular group by placing the tip of electrode perpendicularly to contact the genicular nerves. | Procedure or surgery | Perpendicular Group |
| Parallel GroupRadiofrequency ablation was applied to the parallel group by placing the electrode lay parallel to contact the genicular nerves. | Procedure or surgery | Parallel Group |
Primary outcome
The proportion of patients with a pain reduction of at least 50% compared to baseline expressed by the numerical rating scale (NRS)
Time frame: 6 months after intervention.
The proportion of patients with a pain reduction of at least 50% compared to baseline expressed by the numerical rating scale (NRS) (0-10).The lower the score, the least pain the patient experiences.
1 secondary outcome
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 6 months after intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 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.
Health Science University Diskapi Yildirim Beyazıt Training and Research Hospital
Yenimahalle, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perpendicular Group and Parallel Group in people with Knee Osteoarthritis, run by Diskapi Teaching and Research 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 1 inclusion and 4 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 4 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with a pain reduction of at least 50% compared to baseline expressed by the numerical rating scale (NRS) (time frame: 6 months after intervention.). 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 4 Apr 2023.