Knee Osteoarthritisorconventional Radiofrequencyandgeniculated NervesNCT06613815
EFFECTIVENESS OF CONVENTIONAL RADIOFREQUENCY OF THE GENICULAR NERVES GUIDED BY SCOPIC VERSUS ULTRASOUND FOR THE TREATMENT OF POSTQUIRURGICAL GONALGIA
An observational study of Knee Osteoarthritisorconventional Radiofrequencyandgeniculated Nerves, run by Fundación Pública Galega Instituto de Investigación Sanitaria. at 1 site in Spain.
Trial summary
Knee osteoarthritis is one of the most common joint conditions in the elderly population, characterized by causing pain, stiffness and functional disability in a significant number of cases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritisorconventional Radiofrequencyandgeniculated Nerves
- What is being tested?
- radiofrequency of the geniculate nerves
- How many people
- 57 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2019to 31 Jan 2024
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Due to the reason that it is a retrospective study, sample size calculation was not performed and all patients who underwent this analgesic technique in the last 5 years were consecutively included. Continuous quantitative variables were expressed as mean and standard deviation, and the results were contrasted using the Student's T test if data reached normality criteria. Otherwise, they were expressed as median and range and contrasted using the Mann-Whitney U-test. Qualitative variables were expressed in absolute numbers and relative frequencies, and data were contrasted using the Chi square and Fisher's test when necessary. Normality tests were conducted for all continuous quantitative variables. The data were processed using SPSS software version 20.0 (IBM Corporation, Armonk, NY, USA), assuming a p-value below 0.05 as significant.
Who may be able to join
- people over 18 years of age,physical status ASA I - III, suffering postsurgical chronic Knee pain for more than 3 months, with a baseline pain scale score (NRS) >5 points and failure of other conservative treatments (painkillers, rehabilitation and intraarticular infiltration).
Who cannot join
- any contraindication for performing regional techniques (infection at the puncture point, alteration of haemostasis, allergy to local anesthetics), pacemaker carriers, non-approval of informed consent, inability to assess postoperative pain, cognitive impairment and known neuropathy of the operated limb.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECTIVENESS OF CONVENTIONAL RADIOFREQUENCY OF THE GENICULATED NERVES GUIDED BY SCOPIC VERSUS ULTRASOUND IMAGING FOR THE TREATMENT OF POSTQUIRURGICAL GONALGIA: A RETROSPECTIVE OBSERVATIONAL STUDY
Knee osteoarthritis is one of the most common joint conditions in the elderly population, characterized by causing pain, stiffness and functional disability in a significant number of cases.
Retrospective, non-randomized observational study, between January 2019 and January 2024, comparing the analgesic effectiveness of conventional radiofrequency of the geniculate nerves performed in a cohort of patients with a scopy-guided technique (scopic group, N=19) versus the ultrasound-guided technique (US group, N=38) in patients referred to the pain unit for chronic gonalgia of moderate-severe intensity after knee surgery.
Read more
The main variable studied was the measurement of pain intensity according to the numerical rating scale (NRS) before performing the technique and at 3, 6 and 12 months after radiofrequency denervation of the geniculate nerves.
Conventional radiofrequency of the geniculate nerves of the knee significantly reduces pain intensity over a period of at least 6 to 12 months in patients with chronic postoperative gonalgia, with the ultrasound-guided technique presenting the lowest scores on the numerical pain scale.
It is a simple technique to perform and with few adverse effects, which allows patients to reduce the dose of opioid drugs they take chronically.
Read the detailed description
Knee osteoarthritis is one of the most common joint conditions in the elderly population, characterized by causing pain, stiffness and functional disability in a significant number of cases.
Retrospective, non-randomized observational study, between January 2019 and January 2024, comparing the analgesic effectiveness of conventional radiofrequency of the geniculate nerves performed in a cohort of patients with a scopy-guided technique (scopic group, N=19) versus the ultrasound-guided technique (US group, N=38) in patients referred to the pain unit for chronic gonalgia of moderate-severe intensity after knee surgery.
The main variable studied was the measurement of pain intensity according to the numerical rating scale (NRS) before performing the technique and at 3, 6 and 12 months after radiofrequency denervation of the geniculate nerves.
The following were measured as secondary variables: the degree of motor block, the reduction in the consumption of opioid drugs, the ease of performing the technique, the degree of patient satisfaction, the appearance of adverse effects and complications related to the technique.
A total of 57 patients were included in the study (19 scopic group and 38 US group). Both techniques were shown to be effective for the control of chronic knee pain. There was a statistically significant reduction in pain intensity at 3, 6 and 12 months (3 [1-5] vs 2 [0-3]; p=0.02 / 3 [2-5] vs 2 [0-3]; p=0.00 / 4 [2-5] vs 2 [1-3]; p=0.00), as well as a reduction in minor opioid requirements (52.6% vs 18.4% p=0.001) in the ultrasound-guided group. No statistical differences were observed between the two groups in terms of the consumption of major opioids or complications of the technique, except for a higher incidence of motor block in the ultrasound-guided group (Bromage scale II: 0% vs 13.2%, p=0.15), which was not clinically relevant.
The degree of patient satisfaction was high in both groups, with no differences being found.Conventional radiofrequency of the geniculate nerves of the knee significantly reduces pain intensity over a period of at least 6 to 12 months in patients with chronic postoperative gonalgia, with the ultrasound-guided technique presenting the lowest scores on the numerical pain scale.
It is a simple technique to perform and with few adverse effects, which allows patients to reduce the dose of opioid drugs they take chronically.
- Being tested
- radiofrequency of the geniculate nerves
- Keywords
- knee osteoarthritis, conventional radiofrequency, geniculated nerves, chronic pain.
- Medical subject headings
- Osteoarthritis, Knee, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequency of the geniculate nervesOther
radiofrequency of the geniculate nerveswith a scopy-guided technique versus the ultrasound-guided technique
| Study group | Role | What they receive |
|---|---|---|
| (scopic group, N=19) | comparing the analgesic effectiveness of conventional radiofrequency of the geniculate nerves performed in a cohort of patients with a scopy-guided technique (scopic group, N=19) Receives: Other: radiofrequency of the geniculate nerves | |
| the ultrasound-guided technique (US group, N=38) | , comparing the analgesic effectiveness of conventional radiofrequency of the geniculate nerves performed in a cohort of patients with a scopy-guided technique (scopic group, N=19) versus the ultrasound-guided technique Receives: Other: radiofrequency of the geniculate nerves |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main variable was the measurement of pain intensity assessed by the NRS (Numerical Rating Scale) at different moments: baseline and at 3, 6 and 12 months after performing the technique.
The main variable was the measurement of pain intensity assessed by the NRS (Numerical Rating Scale) at different moments: baseline and at 3, 6 and 12 months after performing the technique. As secondary variables, the reduction in opioid requirements were registered.
Measured: January 2019-January 2024
Secondary outcomes (1)
As secondary variables, the reduction in opioid requirements were registered.
As secondary variables, the reduction in opioid requirements were registered.
Measured: January 2019-January 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start1 Jan 2019
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Osteoarthritisorconventional Radiofrequencyandgeniculated NervesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Galega Instituto de Investigación Sanitaria.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ÁLVARO MANUEL GASALLA CADÓRNIGA, Fundación Pública Galega Instituto de Investigación Sanitaria.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613815
- Sponsor's protocol ID
- nº 2024/211
- Status last verified
- Jan 2024
- First submitted
- 23 Sep 2024
- Last updated
- 26 Sep 2024
- 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 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTIVENESS OF CONVENTIONAL RADIOFREQUENCY OF THE GENICULATED NERVES GUIDED BY SCOPIC VERSUS ULTRASOUND IMAGING FOR THE TREATMENT OF POSTQUIRURGICAL GONALGIA: A RETROSPECTIVE OBSERVATIONAL STUDY
- ClinicalTrials.gov ID
- NCT06613815
- Acronym / sponsor ID
- nº 2024/211
- Keywords
- knee osteoarthritis, conventional radiofrequency, geniculated nerves, chronic pain.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Fundación Pública Galega Instituto de Investigación Sanitaria.University, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 26 Sep 2024 (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.
Knee osteoarthritis is one of the most common joint conditions in the elderly population, characterized by causing pain, stiffness and functional disability in a significant number of cases.
Retrospective, non-randomized observational study, between January 2019 and January 2024, comparing the analgesic effectiveness of conventional radiofrequency of the geniculate nerves performed in a cohort of patients with a scopy-guided technique (scopic group, N=19) versus the ultrasound-guided technique (US group, N=38) in patients referred to the pain unit for chronic gonalgia of moderate-severe intensity after knee surgery.
The main variable studied was the measurement of pain intensity according to the numerical rating scale (NRS) before performing the technique and at 3, 6 and 12 months after radiofrequency denervation of the geniculate nerves.
Conventional radiofrequency of the geniculate nerves of the knee significantly reduces pain intensity over a period of at least 6 to 12 months in patients with chronic postoperative gonalgia, with the ultrasound-guided technique presenting the lowest scores on the numerical pain scale.
It is a simple technique to perform and with few adverse effects, which allows patients to reduce the dose of opioid drugs they take chronically.
Detailed description
Knee osteoarthritis is one of the most common joint conditions in the elderly population, characterized by causing pain, stiffness and functional disability in a significant number of cases.
Retrospective, non-randomized observational study, between January 2019 and January 2024, comparing the analgesic effectiveness of conventional radiofrequency of the geniculate nerves performed in a cohort of patients with a scopy-guided technique (scopic group, N=19) versus the ultrasound-guided technique (US group, N=38) in patients referred to the pain unit for chronic gonalgia of moderate-severe intensity after knee surgery.
The main variable studied was the measurement of pain intensity according to the numerical rating scale (NRS) before performing the technique and at 3, 6 and 12 months after radiofrequency denervation of the geniculate nerves.
The following were measured as secondary variables: the degree of motor block, the reduction in the consumption of opioid drugs, the ease of performing the technique, the degree of patient satisfaction, the appearance of adverse effects and complications related to the technique.
A total of 57 patients were included in the study (19 scopic group and 38 US group). Both techniques were shown to be effective for the control of chronic knee pain. There was a statistically significant reduction in pain intensity at 3, 6 and 12 months (3 [1-5] vs 2 [0-3]; p=0.02 / 3 [2-5] vs 2 [0-3]; p=0.00 / 4 [2-5] vs 2 [1-3]; p=0.00), as well as a reduction in minor opioid requirements (52.6% vs 18.4% p=0.001) in the ultrasound-guided group. No statistical differences were observed between the two groups in terms of the consumption of major opioids or complications of the technique, except for a higher incidence of motor block in the ultrasound-guided group (Bromage scale II: 0% vs 13.2%, p=0.15), which was not clinically relevant.
The degree of patient satisfaction was high in both groups, with no differences being found.Conventional radiofrequency of the geniculate nerves of the knee significantly reduces pain intensity over a period of at least 6 to 12 months in patients with chronic postoperative gonalgia, with the ultrasound-guided technique presenting the lowest scores on the numerical pain scale.
It is a simple technique to perform and with few adverse effects, which allows patients to reduce the dose of opioid drugs they take chronically.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (scopic group, N=19) | – | Other: radiofrequency of the geniculate nervescomparing the analgesic effectiveness of conventional radiofrequency of the geniculate nerves performed in a cohort of patients with a scopy-guided technique (scopic group, N=19) |
| the ultrasound-guided technique (US group, N=38) | – | Other: radiofrequency of the geniculate nerves, comparing the analgesic effectiveness of conventional radiofrequency of the geniculate nerves performed in a cohort of patients with a scopy-guided technique (scopic group, N=19) versus the ultrasound-guided technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Due to the reason that it is a retrospective study, sample size calculation was not performed and all patients who underwent this analgesic technique in the last 5 years were consecutively included. Continuous quantitative variables were expressed as mean and standard deviation, and the results were contrasted using the Student's T test if data reached normality criteria. Otherwise, they were expressed as median and range and contrasted using the Mann-Whitney U-test. Qualitative variables were expressed in absolute numbers and relative frequencies, and data were contrasted using the Chi square and Fisher's test when necessary. Normality tests were conducted for all continuous quantitative variables. The data were processed using SPSS software version 20.0 (IBM Corporation, Armonk, NY, USA), assuming a p-value below 0.05 as significant.
Key inclusion criteria (1 listed)
- people over 18 years of age,physical status ASA I - III, suffering postsurgical chronic Knee pain for more than 3 months, with a baseline pain scale score (NRS) >5 points and failure of other conservative treatments (painkillers, rehabilitation and intraarticular infiltration).
Key exclusion criteria (1 listed)
- any contraindication for performing regional techniques (infection at the puncture point, alteration of haemostasis, allergy to local anesthetics), pacemaker carriers, non-approval of informed consent, inability to assess postoperative pain, cognitive impairment and known neuropathy of the operated limb.
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 |
|---|---|---|
| radiofrequency of the geniculate nervesradiofrequency of the geniculate nerveswith a scopy-guided technique versus the ultrasound-guided technique | Other | (scopic group, N=19), the ultrasound-guided technique (US group, N=38) |
Primary outcome
The main variable was the measurement of pain intensity assessed by the NRS (Numerical Rating Scale) at different moments: baseline and at 3, 6 and 12 months after performing the technique.
Time frame: January 2019-January 2024
The main variable was the measurement of pain intensity assessed by the NRS (Numerical Rating Scale) at different moments: baseline and at 3, 6 and 12 months after performing the technique. As secondary variables, the reduction in opioid requirements were registered.
1 secondary outcome
As secondary variables, the reduction in opioid requirements were registered.
Time frame: January 2019-January 2024
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 26 Sep 2024.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritisorconventional Radiofrequencyandgeniculated Nerves, run by Fundación Pública Galega Instituto de Investigación Sanitaria. at 1 site in Spain.
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 1 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 26 Sep 2024. 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 Spain. 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?
The main variable was the measurement of pain intensity assessed by the NRS (Numerical Rating Scale) at different moments: baseline and at 3, 6 and 12 months after performing the technique. (time frame: January 2019-January 2024). 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 Sep 2024.