Comparative study of radiofrequency versus intraarticular corticoid injection for chronic knee pain.

• Conditions: 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: 18.1Level: PTClassification code 10064332Term: Complex regional pain syndromeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2015-002563-41-ES
• Lead Sponsor: Jorge Orduna Valls

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-25
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified