Chronic knee pain (more than 3 months), in patients either non eligible for knee surgery, or with pain after three months of knee surgery. MedDRA version: 18.1 Level: PT Classification code 10064332 Term: Complex regional pain syndrome System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: TRIGON DEPOT 40 mg/ml
Product Name: Triamcinolone acetonide
Pharmaceutical Form: Suspension for injection
Trade Name: LIDOCAINA INYECTABLE BRAUN Sol. iny. 2%
Product Name: Lidocaine hydro
Sponsors
Jorge Orduna Valls
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1- Patient who is informed and gives written consent for study participation. 2- Patients with ages between 40 and 80 years. 3- Non-pregnant women who are willing to adopt effective contraceptive methods during the study. 4- Non-fertile women. 5- Chronic gonalgia (> 3 months) that didn?t respond to conservative treatment, pharmacologic therapy, TENS or rehabilitation. 6- Mechanic-type pain in the affected limb with VAS score > 50 mm during strolling. 7- Stable doses in antialgic drugs for more than 30 days before study initiation. 8- Osteoarthrosis with Kellgren-Lawrence degrees II, III, IV. 9- Patients who underwent Knee Society's Knee Scoring System (KSS). 10- Pain improvement greater than 50% (VAS) after nerve infiltration with local anesthesia. 11- Absence of allergy or reported adverse events after the administration of local anesthetics, steroids or iodinated contrasts. 12- Patients who understood the risks and benefits of the two procedures studied. 13- Patients who are able to attend all the visits scheduled for the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 31 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 31
Exclusion criteria
Exclusion criteria: 1- Signs of alarm or infection in the affected joint. 2- Signs of systemic infection or VIH. 3- Severe psychiatric disorders. 4- Pain with unexplained weight loss of > 5% 90 days before the study. 5- Neuropathic pain in the affected limb. 6- Patients with cancer in the five years before the study, or who have cancer at the time of the study. 7- Patients with coagulation disorders or antiagregant/anticoagulant (except Aspirin < 150 or 300 mg/day) drugs that cannot be discontinued during their recommended intervals before the procedures. 8- Participants in any clinical study at least 30 days before screening. 9- Substance abuse disorders. 10- Patients who are trying to obtain a sick leave, or being recognized with some degree of disability. 11- Pregnancy, or patient not willing to adopt contraceptive methods. 12- Patient under opioid treatment with doses greater than 90 miligrams a day.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of two techniques against chronic knee pain: ultrasound-guided radiofrequency versus the standard treatment (intraarticular injection of corticoids and local anesthetics) assessing: - The reduction in visual analogic scale (VAS) score at weeks 1, 4, 12, 24 in either group(taking as significative a two-points reduction or a > 50% reduction from the initial VAS score). - Assessment of functional changes in the knee articulation measured by the Oxford Knee and the WOMAC scores. - Changes in doses of analgesia administered. - Patient satisfaction (SF-36 questionnaire). - Adverse events incidence.;Secondary Objective: Determinate the efficacy of the echoguided radiofrequency administration over specific nerve branches in the knee. Those branches were previously localized using simple X-ray imaging.;Primary end point(s): Visual Analogic scale (VAS) reduction > 50% from baseline or 2-points reduction at various time points: 1, 4, 12 and 24 weeks.;Timepoint(s) of evaluation of this end point: 1, 4, 12 and 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Assessment of functional changes in the knee articulation measured by the Oxford Knee and the WOMAC scores. - Changes in doses of analgesia administered. - Patient satisfaction (SF-36 questionnaire). - Adverse events incidence.;Timepoint(s) of evaluation of this end point: 1, 4, 12 and 24 weeks. | — |
Countries
Spain
Contacts
Public ContactAnaesthetist - Clinical Trials Info
Aurora Baluja
Outcome results
None listed