Patients With Chronic Knee Pain Treated With Conventional Radiofrequency of the Genicular Nerves

NCT04234984 | Completed Results

• 1 other identifier: RECORGEN
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Knee Pain

Keywords

Conventional radiofrequency

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• The Number of Participants With NRS Reduction ≥50% Compared to Baseline

  6 weeks after treatment

• The Patient's NRS

  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

  after retrieval of informed consent, ranging from 6 weeks to 2.5 years after the procedure

• The Number of Pariticipants Using Strong Opioids

  6 weeks after treatment

• Strong Opioid Use at the Second Time Point

  after retrieval of informed consent, ranging from 6 weeks to 2.5 years after the procedure

Study Arms (1)

Conventional radiofrequency (RF) treatment

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ziekenhuis Oost-Limburg: lead

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

Related Publications (1)

• 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.

  PMID: 34716965 DERIVED

Limitations and Caveats

1. One of the limitations of this study is inherent to its retrospective nature. 2. A second limitation is that comparison with previous studies is difficult due to the use of ultrasound as guidance for the procedure as most of the studies use fluoroscopy-guided RF. 3. Another limitation concerns the subgroup analysis of degenerative knee pain. These results need to be interpreted with caution due to the small number of patients included in this group.

Results Point of Contact

• Title: Prof. Dr. Jan Van Zundert
• Organization: Department of Anaesthesiology & Pain Medicine, Maastricht University Medical Centre, Postbus 5800, 6202 AZ Maastricht, The Netherlands.

jan.van.zundert@mumc.nl

(+32) 475687657

Study Officials

• Jan Van Zundert, MD PhD

  Ziekenhuis Oost-Limburg

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 21, 2020
• Study Start: January 26, 2020
• Primary Completion: November 15, 2020
• Study Completion: November 15, 2020
• Last Updated: June 14, 2022
• Results First Posted: June 14, 2022

Record last verified: 2022-03

Locations

BE (1)