NCT04234984: RECORGEN

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

Completed Results posted Last updated 14 June 2022

What this trial tests

trial in Chronic Knee Pain in 66 participants. Completed in 15 November 2020.

Timeline

26 January 2020

Primary endpoint
15 November 2020

15 November 2020

Quick facts

Lead sponsor	Ziekenhuis Oost-Limburg
Status	Completed
Study type	OBSERVATIONAL
Enrollment	66
Start date	26 January 2020
Primary completion	15 November 2020
Estimated completion	15 November 2020
Sites	1 location across Belgium

Conditions studied

• Chronic Knee Pain — all drugs for Chronic Knee Pain →

Sponsor

Ziekenhuis Oost-Limburg — full company profile →

Who can join

18 and older, any sex, with Chronic Knee Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Number of Patients Reaching Treatment Succes at 6 Weeks Defined as Global Perceived Effect (GPE) of ≥ 50% Compared to Baseline. Primary · 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).

Group	Value	95% CI
Degenerative Knee Pain	4
PPSP	15

The Number of Participants With NRS Reduction ≥50% Compared to Baseline Secondary · 6 weeks after treatment

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.

Group	Value	95% CI
Degenerative Knee Pain	4
PPSP	9

The Patient's NRS Secondary · after retrieval of informed consent, ranging from 6 weeks to 2.5 years after the procedure

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.

Mean NRS at 6 weeks

Group	Value	95% CI
Degenerative Knee Pain	5.6	± 1.9
PPSP	7.3	± 1.7

Mean NRS in treatment success group

Group	Value	95% CI
Degenerative Knee Pain	2.8	± 1.5
PPSP	3.4	± 1.7

Mean NRS in treatment failure group

Group	Value	95% CI
Degenerative Knee Pain	7.1	± 2.4
PPSP	7.5	± 1.5

Mean NRS at the second time point

Group	Value	95% CI
Degenerative Knee Pain	5.3	± 2.0
PPSP	5.5	± 1.9

Mean NRS at the second time point in patients with GPE ≥50%

Group	Value	95% CI
Degenerative Knee Pain	4.0	± 0.0
PPSP	3.8	± 2.2

Mean NRS at the second time point in patients with GPE <50%

Group	Value	95% CI
Degenerative Knee Pain	6.0	± 2.0
PPSP	6.6	± 0.8

The Number of Patients With Subjective Increase in Physical Functioning at the Second Time Point Secondary · after retrieval of informed consent, ranging from 6 weeks to 2.5 years after the procedure

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.

Group	Value	95% CI
Degenerative Knee Pain	1
PPSP	6

The Number of Pariticipants Using Strong Opioids Secondary · 6 weeks after treatment

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.

Patients on strong opioids

Group	Value	95% CI
Degenerative Knee Pain	3
PPSP	8

Patients on strong opioids in treatment success group

Group	Value	95% CI
Degenerative Knee Pain	1
PPSP	3

Patients on strong opioids in treatment failure group

Group	Value	95% CI
Degenerative Knee Pain	2
PPSP	5

Strong Opioid Use at the Second Time Point Secondary · after retrieval of informed consent, ranging from 6 weeks to 2.5 years after the procedure

The change in use of strong opioids is asked telephonically to the patient.

Group	Value	95% CI
Degenerative Knee Pain	1
PPSP	5

The Number of Participants Reaching Treatment Success After Retrieval of the Informed Consent Defined as GPE of ≥ 50% Compared to Baseline. Secondary · after retrieval of informed consent, ranging from 6 weeks to 2.5 years after the procedure

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).

Group	Value	95% CI
Degenerative Knee Pain	2
PPSP	4

Number of Participants With Post-treatment Complications Secondary · 6 weeks after treatment.

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.

Adverse events

Group	Value	95% CI
Degenerative Knee Pain	3
PPSP	6

Severe adverse events

Group	Value	95% CI
Degenerative Knee Pain	0
PPSP	1

Number of Participants With Post-treatment Complications Secondary · after retrieval of informed consent, ranging from 6 weeks to 2.5 years after the procedure

Adverse events related to the conventional radiofrequency therapy will be assessed telephonically

Adverse events

Group	Value	95% CI
Degenerative Knee Pain	0
PPSP	1

Severe adverse events

Group	Value	95% CI
Degenerative Knee Pain	0
PPSP	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Collection of data happened in a time period that was different for every patient varying from 6 weeks to 2.5 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Degenerative Knee Pain

Serious: 0/13 (0%)

Deaths: 1/13

PPSP

Serious: 1/46 (2%)

Deaths: 0/46

Serious adverse events (1 terms)

Reaction	System	Degenerative Knee Pain	PPSP
Complex regional pain syndrome (CRPS)	Nervous system disorders	—	—

Other adverse events (5 terms — click to expand)

Reaction	System	Degenerative Knee Pain	PPSP
Hypoesthesia	Nervous system disorders	—	—
Instability while walking	Musculoskeletal and connective tissue disorders	—	—
Increase in pain	Musculoskeletal and connective tissue disorders	—	—
Self-limiting hematoma	Injury, poisoning and procedural complications	—	—
Cracking of the joint	Musculoskeletal and connective tissue disorders	—	—

Most-reported serious reactions: Complex regional pain syndrome (CRPS).

Data from ClinicalTrials.gov NCT04234984 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A retrospective study on patients with chronic knee pain treated with ultrasound-guided radiofrequency of the genicular nerves (RECORGEN trial).
   Belba A, Vanneste T, Van Kuijk SMJ, Mesotten D, et al · · 2022 · cited 11× · PMID 34716965 · DOI 10.1111/papr.13088