Outcome Measures of Pulsed Radiofrequency of the Genicular Nerves When Performed With and Without Concomitant Local Corticosteroid Administration

NCT ID: NCT04940832

Last Updated: 2022-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A single blinded randomized controlled trial to compare outcomes of patients with chronic knee pain receiving radiofrequency with or without corticosteroids.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Pain Chronic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

radiofrequency with corticosteroids

corticosteroids- 80mg depo-medrol Pulsed radiofrequency to 42 derees celsius for 6 minutes

Group Type ACTIVE_COMPARATOR

pulsed radiofrequency modulation

Intervention Type DEVICE

a percutaneous needle electrode to apply pulsed RF signals that modulate the activity of sensory nerves. The pulsing of the RF signal permits a maximum temperature to be achieved - usually 42 Celsius. This helps prevent collateral damage from occurring during the procedure and should help reduce procedural complications.

radiofrequency without corticosteroids

Pulsed radiofrequency to 42 derees celsius for 6 minutes

Group Type ACTIVE_COMPARATOR

pulsed radiofrequency modulation

Intervention Type DEVICE

a percutaneous needle electrode to apply pulsed RF signals that modulate the activity of sensory nerves. The pulsing of the RF signal permits a maximum temperature to be achieved - usually 42 Celsius. This helps prevent collateral damage from occurring during the procedure and should help reduce procedural complications.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

pulsed radiofrequency modulation

a percutaneous needle electrode to apply pulsed RF signals that modulate the activity of sensory nerves. The pulsing of the RF signal permits a maximum temperature to be achieved - usually 42 Celsius. This helps prevent collateral damage from occurring during the procedure and should help reduce procedural complications.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Men and women with pain secondary to osteoarthritis of the knee
* Age of 18 years and up
* Fits criteria for procedure of genicular nerve block and pulsed radiofrequency neuromodulation

Exclusion Criteria

* Patients who are incapable of judgment and/or to give informed consent
* Patients who are pregnant
* Patients who are under 18 years old
* Patients who have allergies to local anesthetic
* Patients with platelet dysfunction or bleeding disorders
* Patients who are currently mentally unstable
* Patients who have a diagnosis of fibromyalgia
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Itay GoorAryeh

Doctor Head of Pain Clinics, Sheba Medical Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sheba Medical Center

Tel Litwinsky, , Israel

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Matthew Medwick, Doctor

Role: CONTACT

03-5303106

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Matthew Medwick, Doctor

Role: primary

03-5303106

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Knee_pain_radiofrequency

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Treatment for Whiplash Injury
NCT04959721 UNKNOWN NA