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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional radiofrequency (RF) treatment | All patients with chronic knee pain who qualify for a conventional RF treatment of the genicular nerves |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Jan Van Zundert, MD PhD | Ziekenhuis Oost-Limburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg | Genk | 3600 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34716965 | Derived | 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. |
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Excluded patients (n=7): Chronic widespread pain (n=7)
September 2017 to June 2020. Patients receiving treatment in Hospital Oost-Limburg, Genk, Belgium.
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| ID | Title | Description |
|---|---|---|
| FG000 | Conventional Radiofrequency (RF) Treatment | All patients with chronic knee pain who qualify for a conventional radiofrequency (RF) treatment of the genicular nerves |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Follow-up at 6 Weeks |
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| Follow-up at the Second Time Point |
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| ID | Title | Description |
|---|---|---|
| BG000 | Degenerative Knee Pain | All patients with chronic knee pain who suffer from osteoarthritis (OA), soft tissue (e.g., ligament) disease and posttraumatic pain. |
| BG001 | Persistent Post-surgical Pain (PPSP) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Count of Participants | Participants | 6 weeks after treatment |
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Collection of data happened in a time period that was different for every patient varying from 6 weeks to 2.5 years
Adverse events were defined as any undesirable experience occurring to a subject during the study that is related to the investigational intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Degenerative Knee Pain | All patients with chronic knee pain who suffer from OA, soft tissue (e.g., ligament) disease and posttraumatic pain. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Complex regional pain syndrome (CRPS) | Nervous system disorders | Systematic Assessment | CRPS of the treated knee |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Instability while walking | Musculoskeletal and connective tissue disorders | Systematic Assessment | Instability, no fall |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Jan Van Zundert | Department of Anaesthesiology & Pain Medicine, Maastricht University Medical Centre, Postbus 5800, 6202 AZ Maastricht, The Netherlands. | (+32) 475687657 | jan.van.zundert@mumc.nl |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 19, 2020 | Dec 1, 2021 | Prot_SAP_000.pdf |
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| 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. | 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. | 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. | 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. | 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). | 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. | 6 weeks after treatment. |
| Number of Participants With Post-treatment Complications | Adverse events related to the conventional radiofrequency therapy will be assessed telephonically | after retrieval of informed consent, ranging from 6 weeks to 2.5 years after the procedure |
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All patients with chronic knee pain who suffer from PPSP after all types orthopaedic surgeries of the knee.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Index knee | Number | participants |
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| Patients on strong opioids at baseline consultation | Count of Participants | Participants |
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| Mean NRS (± SD) prior to RF treatment | Mean Numerical Rating Scale (NRS) (± standard deviation (SD)) prior to Radiofrequency treatment The NRS score is a score form 0 to 10. Patients are asked to rate their pain from 0 to 10 where 0 mean ' No pain' while 10 means ' Worst pain'. | Mean | Standard Deviation | units on a scale. |
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| OG001 | PPSP | All patients with chronic knee pain who suffer from PPSP after all types orthopaedic surgeries of the knee. |
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| Secondary | 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. | Posted | Count of Participants | Participants | 6 weeks after treatment |
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| Secondary | 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. | At the second time point: 4 patients with degenerative knee pain and 13 patients with PPSP were analysed. | Posted | Mean | Standard Deviation | score on a scale | after retrieval of informed consent, ranging from 6 weeks to 2.5 years after the procedure |
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| Secondary | 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. | 19 patients in total reached treatment succes at 6 weeks, 4 of which suffered from degenerative knee pain and 13 from PPSP. Two of these patients were excluded from analysis due to death and being mentally unable to fulfill the questionnaire. As a result 17 patients were analyzed for this endpoint. | Posted | Count of Participants | Participants | after retrieval of informed consent, ranging from 6 weeks to 2.5 years after the procedure |
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| Secondary | 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. | Strong opioid use is measured firstly in both subgroups and secondly in the treatment success and treatment failure group. | Posted | Count of Participants | Participants | 6 weeks after treatment |
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| Secondary | Strong Opioid Use at the Second Time Point | The change in use of strong opioids is asked telephonically to the patient. | 19 patients in total reached treatment succes at 6 weeks, 4 of which suffered from degenerative knee pain and 13 from PPSP. Two of these patients were excluded from analysis due to death and being mentally unable to fulfill the questionnaire. As a result 17 patients were analyzed for this endpoint. | Posted | Count of Participants | Participants | after retrieval of informed consent, ranging from 6 weeks to 2.5 years after the procedure |
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| Secondary | 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). | 19 patients in total reached treatment succes at 6 weeks, 4 of which suffered from degenerative knee pain and 13 from PPSP. Two of these patients were excluded from analysis due to death and being mentally unable to fulfill the questionnaire. As a result 17 patients were analyzed for this endpoint. | Posted | Count of Participants | Participants | after retrieval of informed consent, ranging from 6 weeks to 2.5 years after the procedure |
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| Secondary | 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. | Posted | Count of Participants | Participants | 6 weeks after treatment. |
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| Secondary | Number of Participants With Post-treatment Complications | Adverse events related to the conventional radiofrequency therapy will be assessed telephonically | 19 patients in total reached treatment succes at 6 weeks, 4 of which suffered from degenerative knee pain and 13 from PPSP. Two of these patients were excluded from analysis due to death and being mentally unable to fulfill the questionnaire. As a result 17 patients were analyzed for this endpoint. | Posted | Count of Participants | Participants | after retrieval of informed consent, ranging from 6 weeks to 2.5 years after the procedure |
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| 1 |
| 13 |
| 0 |
| 13 |
| 3 |
| 13 |
| EG001 | PPSP | All patients with chronic knee pain who suffer from PPSP after all types orthopaedic surgeries of the knee. | 0 | 46 | 1 | 46 | 5 | 46 |
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| Hypoesthesia | Nervous system disorders | Systematic Assessment |
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| Increase in pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Self-limiting hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
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| Cracking of the joint | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Mean NRS in treatment success group |
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| Mean NRS in treatment failure group |
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| Mean NRS at the second time point |
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| Mean NRS at the second time point in patients with GPE ≥50% |
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| Mean NRS at the second time point in patients with GPE <50% |
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| Patients on strong opioids in treatment success group |
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| Patients on strong opioids in treatment failure group |
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