Ultrasound-Guided Pulsed Radiofrequency In The Treatment Of Patients With Osteoarthritis Knee (USPRFGENOAK)

NCT ID: NCT02915120

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-27
• Study Completion Date: 2024-12-31

Brief Summary

The purpose of this study is to determine if patients with chronic painful knee osteoarthritis experience meaningful and long-term improvement in pain, function, and analgesic use after ultrasound-guided pulsed radiofrequency of the genicular nerves following a double diagnostic genicular nerve blocks.

Detailed Description

Osteoarthritis of the knee (kOA) is one of the main causes of disability. Population-based studies revealed that symptomatic kOA is present in 20-30% of the elderly population aged >65 years, and its prevalence is increasing due in part to the aging of the population. The goals of management of patients with kOA are to control pain and to minimize disability. Evidence-based guidelines from National Institute of Health and Clinical Excellence (NICE) and Osteoarthritis Research International (OARSI) suggest that the treatment should be multidisciplinary. Optimal management requires a combination of non-pharmacological (changes in lifestyle, pacing of activities, weight reduction, regular aerobic, acupuncture, muscle strengthening and range of motion exercises) and pharmacological modalities (paracetamol) when additional treatment is required. Total knee arthroplasty (TKA) should be considered for patients with significant symptoms, and/or functional limitations associated with a reduced health-related quality of life, despite conservative therapy. However, there are some fragile patients who are at high risk during surgery and other patients who are not willing to undergo surgery. Because the number of patients will increase as the population ages, alternative approaches to alleviate their joint pain other than conventional treatments are necessary. Ultrasound-guided pulsed radiofrequency of the genicular has recently become a promising treatment option in the management of osteoarthritis related knee pain.

This study is a randomized, double-blind, placebo-controlled trial, parallel design. 142 out-patients with kOA will be recruited from Mallorca, Spain. Participants will be randomly allocated into two groups: Ultrasound-Guided Sham Genicular Nerve Pulsed Radiofrequency without active treatment (Sham GENPRF) and Ultrasound-Guided Real Genicular Nerve Pulsed Radiofrequency (Real GENPRF). All patients will be examined before and 1, 3, 6 and 12 months after the treatment (sham or active).

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Real Pulsed Radiofrequency

Before needle insertion, the patient's inferomedial (IM), superomedial (SM), and superolateral (SL) GN branches will be identified under ultrasound guidance. RF needles and probes will be advanced to each of the target nerves under ultrasound guidance. A 50 Hz-frequency sensorial stimulation will be applied with a threshold of \< 0.5 mA to identify the nerve position, the current intensity (mA) will be reduced at \< 0,2 mA. During the sensorial stimulation, the patients will be asked if they feel tingling, pain, or discomfort inside the knee. The RF probe will be maintained in place until one of those feelings is elicited. In order to avoid inactivating motor nerves, the nerve will be tested for the absence of fasciculation in the the lower extremity on stimulation of 0,5 mA at 2 Hz.

Group Type: ACTIVE_COMPARATOR

Real Pulsed Radiofrequency

Intervention Type: PROCEDURE

Pulsed Radiofrequency uses radiofrequency current in short (20 ms), high-voltage bursts; the "silent" phase (480 ms) allows time for heat elimination, generally keeping the target tissue below 42° C. The Radiofrequency (RF) electrode will be inserted through the canula, and RF lesions will be generated by applying pulsed RF treatment to the inferomedial (IM), superomedial (SM), and superolateral (SL) GN branches for 8 minutes at 42°C.

Sham Pulsed Radiofrequency

Control patients will undergo the same procedure. The sensorial and motor stimulations will be applied too. The RF electrode will be then inserted through the cannula, and RF lesions will be simulated without applying pulsed RF treatment to the IM, SM and SL, GN branches for 8 minutes each GN branch and the temperature of the electrode tip was not raised.

Group Type: SHAM_COMPARATOR

Sham Pulsed Radiofrequency

Intervention Type: PROCEDURE

Control patients will undergo the same procedure. The sensorial and motor stimulations will be applied too. The RF electrode will be then inserted through the cannula, and RF lesions will be simulated without applying pulsed RF treatment to the IM, SM and SL, GN branches for 8 minutes each GN branch and the temperature of the electrode tip was not raised.

Interventions

Real Pulsed Radiofrequency

Pulsed Radiofrequency uses radiofrequency current in short (20 ms), high-voltage bursts; the "silent" phase (480 ms) allows time for heat elimination, generally keeping the target tissue below 42° C. The Radiofrequency (RF) electrode will be inserted through the canula, and RF lesions will be generated by applying pulsed RF treatment to the inferomedial (IM), superomedial (SM), and superolateral (SL) GN branches for 8 minutes at 42°C.

Intervention Type: PROCEDURE

Sham Pulsed Radiofrequency

Control patients will undergo the same procedure. The sensorial and motor stimulations will be applied too. The RF electrode will be then inserted through the cannula, and RF lesions will be simulated without applying pulsed RF treatment to the IM, SM and SL, GN branches for 8 minutes each GN branch and the temperature of the electrode tip was not raised.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Chronic knee pain with pain intensity of at least 4 out 10 on the VAS on most or all days for more than 3 months
• Patients of either sex with primary osteoarthritis of one or both knees fulfilling diagnostic criteria for osteoarthritis knee laid down by American College of Rheumatology.
• Patients also had to have a Kellgren-Lawrence (radiologic criterion) score of at least 2
• Pain resistant to conventional therapy including NSAIDs, opioids, muscle relaxants, oral steroids, physical therapy, and intra-articular injection therapy.

Exclusion Criteria

• The patients with secondary osteoarthritis of knees
• Associated systemic arthropathies, e.g. rheumatoid arthritis and gout
• Previous radiofrequency ablation treatment for similar symptoms.
• Intra-articular knee corticosteroid or hyaluronic acid injection in the past 3 months.
• Active systemic or local infections at the site of proposed needle and electrode placement.
• Coagulopathy or other bleeding disorder
• Cognitive deficit.
• Unstable medical or psychiatric illness.
• Previous knee joint replacement surgery
• Patients missing two or more appointments consecutively were excluded from the study

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Son Llatzer

OTHER

Sponsor Role: lead

Responsible Party

Javier Mata

Chief of Section of Anesthesiology and Reanimation Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Javier Mata, MD

Role: PRINCIPAL_INVESTIGATOR

Son Llatzer University Hospital

Locations

Son Llatzer University Hospital

Palma, Balear Islands, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Javier Mata, MD

Role: CONTACT

jmata@hsll.es

0034871201233 ext. 1600

Facility Contacts

Javier Mata, MD

Role: primary

jmata@hsll.es

0034871202133 ext. 1600

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Other Identifiers

RFPGEN-001

Identifier Type: -

Identifier Source: org_study_id