Chronic Knee PainRECORGENNCT04234984
Patients With Chronic Knee Pain Treated With Conventional Radiofrequency of the Genicular Nerves
An observational study of Chronic Knee Pain, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
Trial summary
Management of chronic knee pain remains a challenge to the treating physician. A radiofrequency treatment of the genicular nerves is a not yet established but promising technique. This procedure is minimal invasive and has few adverse events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Knee Pain
- How many people
- 66 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Jan 2020to 15 Nov 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: All patients with chronic knee pain who qualify for a conventional RF treatment of the genicular nerves can be possible candidated for this retrospective study
Who may be able to join
- All patients with chronic knee pain who qualify for a conventional RF treatment of the genicular nerves
Who cannot join
- A negative diagnostic block with lidocaine 2% 1 ml of the three genicular nerves defined as less than 50% pain reduction
- Chronic widespread pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Single-center Cohort Study on Patients With Chronic Knee Pain Treated With Conventional Radiofrequency of the Genicular Nerves
Management of chronic knee pain remains a challenge to the treating physician. A radiofrequency treatment of the genicular nerves is a not yet established but promising technique. This procedure is minimal invasive and has few adverse events. For these reasons it can be advantageous and fulfilling the unmet needs of these chronic knee pain patients warranting further research of its efficacy.
To investigate this efficacy, all patients treated with radiofrequency ablation in the multidisciplinary chronic pain center between 1 September 2017 and 31 December 2019 with exclusion of patients with chronic widespread pain, will be retrospectively analyzed in a single-center cohort.
Read the detailed description
This project has as primary objective the evaluation of treatment success of a conventional radiofrequency treatment of the genicular nerves in patients diagnosed with chronic knee pain due to osteoarthritis of the knee or persistent post-surgical pain (PPSP) at six weeks post treatment. Secondary objectives are evaluation of treatment effect at a third time point at the end of the inclusion period, subgroup analysis of treatment success based on indication to treatment, evaluation of subjective functional improvement and change in analgesics, estimation of the duration of effect of the treatment and adverse events.
This study includes all patients treated with radiofrequency ablation in the multidisciplinary chronic pain center in Ziekenhuis Oost-Limburg, Campus Sint-Barbara between 1 September 2017 and 31 December 2019 with exclusion of patients with chronic widespread pain.
The main study outcome is the proportion of patients with a global perceived effect of at least 50% at 6 weeks post intervention. Secondary outcomes include reduction in pain intensity, measured by Numeric Rating Scale (NRS) at six weeks and at a third time point, global perceived effect at a third time point, subjective change in physical functioning, duration effect of the treatment, use of strong opioids, and adverse events.
- Conditions
- Chronic Knee Pain
- Keywords
- Conventional radiofrequency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Conventional radiofrequency (RF) treatment | All patients with chronic knee pain who qualify for a conventional RF treatment of the genicular nerves |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Patients Reaching Treatment Succes at 6 Weeks Defined as Global Perceived Effect (GPE) of ≥ 50% Compared to Baseline.
Treatment success is defined as a global perceived effect (GPE) of at least 50% at measurement time point compared to baseline.
Global perceived effect (GPE) scales are used as an overall outcome measure for patients with pain, as they may cover additional aspects to pain relief and physical function that are important to the individual. Patients are asked to response on the question of how the treatment influenced the pain symptoms. The patients were asked to expres their answer in percentage where 0 % ( no improvement) to 100 (total improvement, the symptoms are gone).
Measured: 6 weeks after treatment
Secondary outcomes (8)
The Number of Participants With NRS Reduction ≥50% Compared to Baseline
The numeric rating scale (NRS) is used to assess pain intensity varying from 0 (no pain) to 10 (intense pain). This scale was retrieved retrospectively out of the patient file.
NRS reduction ≥50% is calculated using the NRS at 6 weeks compared to the NRS at baseline.
Measured: 6 weeks after treatment
The Patient's NRS
The numeric rating scale (NRS) is used to assess pain intensity varying from 0 (no pain) to 10 (intense pain). This scale will be asked telephonically to the patient.
Measured: after retrieval of informed consent, ranging from 6 weeks to 2.5 years after the procedure
The Number of Patients With Subjective Increase in Physical Functioning at the Second Time Point
The question 'Do you experience at the moment functional improvement in comparison with before the treatment?' is asked telephonically to the patient. The possible answers are 'no increase in physical functioning' and ' yes, there was an increase in physical funcitoning'. An increase in physical functioning is the best outcome.
Measured: after retrieval of informed consent, ranging from 6 weeks to 2.5 years after the procedure
The Number of Pariticipants Using Strong Opioids
The change in use of strong opioids is retrieved retrospectively out of the patient file. The answer to the use of strong opioids is yes or no. No use of strong opioids is a better outcome.
Measured: 6 weeks after treatment
Strong Opioid Use at the Second Time Point
The change in use of strong opioids is asked telephonically to the patient.
Measured: after retrieval of informed consent, ranging from 6 weeks to 2.5 years after the procedure
The Number of Participants Reaching Treatment Success After Retrieval of the Informed Consent Defined as GPE of ≥ 50% Compared to Baseline.
Treatment success is defined as a global perceived effect (GPE) of at least 50% at measurement time point compared to baseline.
Global perceived effect (GPE) scales are used as an overall outcome measure for patients with pain, as they may cover additional aspects to pain relief and physical function that are important to the individual. Patients are asked to response on the question of how the treatment influenced the pain symptoms. The patients were asked to expres their answer in percentage where 0 % ( no improvement) to 100 (total improvement, the symptoms are gone).
Measured: after retrieval of informed consent, ranging from 6 weeks to 2.5 years after the procedure
Number of Participants With Post-treatment Complications
Adverse events related to the conventional radiofrequency therapy will be assessed. This will be assessed retrospectively in the patient file according to the standard of care consultation at 6 weeks after treatment.
Measured: 6 weeks after treatment.
Number of Participants With Post-treatment Complications
Adverse events related to the conventional radiofrequency therapy will be assessed telephonically
Measured: after retrieval of informed consent, ranging from 6 weeks to 2.5 years after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start26 Jan 2020
- Primary completion15 Nov 2020
- Study completion15 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Knee PainStudies 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Van Zundert, Ziekenhuis Oost-Limburg
- Investigators
- Jan Van Zundert, MD PhD, Principal investigator, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234984
- Sponsor's protocol ID
- RECORGEN
- Acronym
- RECORGEN
- Status last verified
- Mar 2022
- First submitted
- 7 Jan 2020
- Last updated
- 14 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Belba A, Vanneste T, Van Kuijk SMJ, Mesotten D, Mestrum R, Van Boxem K, Van Lantschoot A, Bellemans J, Van de Velde M, Van Zundert J. A retrospective study on patients with chronic knee pain treated with ultrasound-guided radiofrequency of the genicular nerves (RECORGEN trial). Pain Pract. 2022 Mar;22(3):340-348. doi: 10.1111/papr.13088. Epub 2021 Nov 9.
PubMed 34716965
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Single-center Cohort Study on Patients With Chronic Knee Pain Treated With Conventional Radiofrequency of the Genicular Nerves
- ClinicalTrials.gov ID
- NCT04234984
- Acronym / sponsor ID
- RECORGEN / RECORGEN
- Conditions
- Chronic Knee Pain
- Keywords
- Conventional radiofrequency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Study start
- 26 Jan 2020 (actual)
- Primary completion
- 15 Nov 2020 (actual)
- Study completion
- 15 Nov 2020 (actual)
- First posted
- 21 Jan 2020 (actual)
- Results
- Posted 14 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Management of chronic knee pain remains a challenge to the treating physician. A radiofrequency treatment of the genicular nerves is a not yet established but promising technique. This procedure is minimal invasive and has few adverse events. For these reasons it can be advantageous and fulfilling the unmet needs of these chronic knee pain patients warranting further research of its efficacy.
To investigate this efficacy, all patients treated with radiofrequency ablation in the multidisciplinary chronic pain center between 1 September 2017 and 31 December 2019 with exclusion of patients with chronic widespread pain, will be retrospectively analyzed in a single-center cohort.
Detailed description
This project has as primary objective the evaluation of treatment success of a conventional radiofrequency treatment of the genicular nerves in patients diagnosed with chronic knee pain due to osteoarthritis of the knee or persistent post-surgical pain (PPSP) at six weeks post treatment. Secondary objectives are evaluation of treatment effect at a third time point at the end of the inclusion period, subgroup analysis of treatment success based on indication to treatment, evaluation of subjective functional improvement and change in analgesics, estimation of the duration of effect of the treatment and adverse events.
This study includes all patients treated with radiofrequency ablation in the multidisciplinary chronic pain center in Ziekenhuis Oost-Limburg, Campus Sint-Barbara between 1 September 2017 and 31 December 2019 with exclusion of patients with chronic widespread pain.
The main study outcome is the proportion of patients with a global perceived effect of at least 50% at 6 weeks post intervention. Secondary outcomes include reduction in pain intensity, measured by Numeric Rating Scale (NRS) at six weeks and at a third time point, global perceived effect at a third time point, subjective change in physical functioning, duration effect of the treatment, use of strong opioids, and adverse events.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Conventional radiofrequency (RF) treatment | – | –All patients with chronic knee pain who qualify for a conventional RF treatment of the genicular nerves |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients with chronic knee pain who qualify for a conventional RF treatment of the genicular nerves can be possible candidated for this retrospective study
Key inclusion criteria (1 listed)
- All patients with chronic knee pain who qualify for a conventional RF treatment of the genicular nerves
Key exclusion criteria (2 listed)
- A negative diagnostic block with lidocaine 2% 1 ml of the three genicular nerves defined as less than 50% pain reduction
- Chronic widespread pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Number of Patients Reaching Treatment Succes at 6 Weeks Defined as Global Perceived Effect (GPE) of ≥ 50% Compared to Baseline.
Time frame: 6 weeks after treatment
Treatment success is defined as a global perceived effect (GPE) of at least 50% at measurement time point compared to baseline. Global perceived effect (GPE) scales are used as an overall outcome measure for patients with pain, as they may cover additional aspects to pain relief and physical function that are important to the individual. Patients are asked to response on the question of how the treatment influenced the pain symptoms. The patients were asked to expres their answer in percentage where 0 % ( no improvement) to 100 (total improvement, the symptoms are gone).
8 secondary outcomes
The Number of Participants With NRS Reduction ≥50% Compared to Baseline
Time frame: 6 weeks after treatment
The Patient's NRS
Time frame: after retrieval of informed consent, ranging from 6 weeks to 2.5 years after the procedure
The Number of Patients With Subjective Increase in Physical Functioning at the Second Time Point
Time frame: after retrieval of informed consent, ranging from 6 weeks to 2.5 years after the procedure
The Number of Pariticipants Using Strong Opioids
Time frame: 6 weeks after treatment
Strong Opioid Use at the Second Time Point
Time frame: after retrieval of informed consent, ranging from 6 weeks to 2.5 years after the procedure
The Number of Participants Reaching Treatment Success After Retrieval of the Informed Consent Defined as GPE of ≥ 50% Compared to Baseline.
Time frame: after retrieval of informed consent, ranging from 6 weeks to 2.5 years after the procedure
Number of Participants With Post-treatment Complications
Time frame: 6 weeks after treatment.
Number of Participants With Post-treatment Complications
Time frame: after retrieval of informed consent, ranging from 6 weeks to 2.5 years after the procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34716965Belba A, Vanneste T, Van Kuijk SMJ, Mesotten D, Mestrum R, Van Boxem K, Van Lantschoot A, Bellemans J, Van de Velde M, Van Zundert J. A retrospective study on patients with chronic knee pain treated with ultrasound-guided radiofrequency of the genicular nerves (RECORGEN trial). Pain Pract. 2022 Mar;22(3):340-348. doi: 10.1111/papr.13088. Epub 2021 Nov 9.
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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.
Jan Van Zundert, MD PhD principal investigator
Ziekenhuis Oost-Limburg
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 Chronic Knee Pain, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
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 2 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 14 Jun 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 Belgium. 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?
Yes. Results are posted in the registry (first posted 14 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Number of Patients Reaching Treatment Succes at 6 Weeks Defined as Global Perceived Effect (GPE) of ≥ 50% Compared to Baseline. (time frame: 6 weeks after treatment). 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 NCT04234984, which also lists 1 linked publication.
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 14 Jun 2022.