EFFECTIVENESS OF CONVENTIONAL RADIOFREQUENCY OF THE GENICULAR NERVES GUIDED BY SCOPIC VERSUS ULTRASOUND FOR THE TREATMENT OF POSTQUIRURGICAL GONALGIA

September 25, 2024 updated by: ÁLVARO MANUEL GASALLA CADÓRNIGA, Fundación Pública Galega Instituto de Investigación Sanitaria.

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.

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.

Study Overview

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 Type

Observational

Enrollment (Actual)

57

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Lugo, Spain, 27003
        • Álvaro Manuel Gasalla Cadórniga

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
(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)
radiofrequency of the geniculate nerveswith a scopy-guided technique versus the ultrasound-guided technique
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
radiofrequency of the geniculate nerveswith a scopy-guided technique versus the ultrasound-guided technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
January 2019-January 2024

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
As secondary variables, the reduction in opioid requirements were registered.
Time Frame: January 2019-January 2024
As secondary variables, the reduction in opioid requirements were registered.
January 2019-January 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

January 31, 2024

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

September 23, 2024

First Submitted That Met QC Criteria

September 25, 2024

First Posted (Actual)

September 26, 2024

Study Record Updates

Last Update Posted (Actual)

September 26, 2024

Last Update Submitted That Met QC Criteria

September 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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