Clinical trial NCT04234984: Patients With Chronic Knee Pain Treated With Conventional Radiofrequency of the Genicular Nerves
Official title: A Retrospective Single-center Cohort Study on Patients With Chronic Knee Pain Treated With Conventional Radiofrequency of the Genicular Nerves
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Knee Pain
Keywords: Conventional radiofrequency
Lead sponsor: Ziekenhuis Oost-Limburg
Sponsor class: OTHER
First posted: 2020-01-21
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* All patients with chronic knee pain who qualify for a conventional RF treatment of the genicular nerves

Exclusion Criteria:

* A negative diagnostic block with lidocaine 2% 1 ml of the three genicular nerves defined as less than 50% pain reduction
* Chronic widespread pain

Primary outcomes:
measure: The Number of Patients Reaching Treatment Succes at 6 Weeks Defined as Global Perceived Effect (GPE) of ≥ 50% Compared to Baseline.
timeFrame: 6 weeks after treatment
Secondary outcomes:
measure: The Number of Participants With NRS Reduction ≥50% Compared to Baseline
timeFrame: 6 weeks after treatment
measure: The Patient's NRS
timeFrame: after retrieval of informed consent, ranging from 6 weeks to 2.5 years after the procedure
measure: The Number of Patients With Subjective Increase in Physical Functioning at the Second Time Point
timeFrame: after retrieval of informed consent, ranging from 6 weeks to 2.5 years after the procedure
measure: The Number of Pariticipants Using Strong Opioids
timeFrame: 6 weeks after treatment
measure: Strong Opioid Use at the Second Time Point
timeFrame: after retrieval of informed consent, ranging from 6 weeks to 2.5 years after the procedure
measure: The Number of Participants Reaching Treatment Success After Retrieval of the Informed Consent Defined as GPE of ≥ 50% Compared to Baseline.
timeFrame: after retrieval of informed consent, ranging from 6 weeks to 2.5 years after the procedure
measure: Number of Participants With Post-treatment Complications
timeFrame: 6 weeks after treatment.
measure: Number of Participants With Post-treatment Complications
timeFrame: after retrieval of informed consent, ranging from 6 weeks to 2.5 years after the procedure
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
Study officials:
affiliation: Ziekenhuis Oost-Limburg
name: Jan Van Zundert, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.