Intra-articular Pulsed Radiofrequency Neuromodulation Versus Intra-articular Steroids for Painful Knee Osteoarthritis

NCT ID: NCT04238598

Last Updated: 2023-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-08
• Study Completion Date: 2021-09-01

Brief Summary

To compare the efficacy of intra-articular pulsed radiofrequency to intra-articular steroids in patients with moderate-severe painful osteoarthritis of the knee.

Detailed Description

Patients Adult patients with intractable knee pain for more than 6 months and radiographic evidence of grade II, III or IV knee osteoarthritis. Must not have had a knee injection or other interventional procedure for knee pain within the past 12 weeks. Must be on stable medications for the past 12 weeks and willing to keep medications stable for the first 12 weeks of the study.

Study Design Pilot study will enroll 30 patients randomized 1:1:1.

1. Active control - intra-articular 4 milliliters 0.5% bupivacaine + 10mg dexamethasone + sham Pulsed Radiofrequency

2. Placebo control - intra-articular 5 milliliters 0.9% saline + sham Pulsed Radiofrequency

3. Treatment group - intra-articular 5 milliliters 0.5% bupivacaine + Pulsed Radiofrequency

Methods Two 18-gauge radiofrequency needle with 10 millimeter active tip will be placed intra-articularly from an anterolateral and anteromedial approach to target the medial and lateral compartments. Once satisfactory fluoroscopic placement is noted, the Pulsed Radiofrequency or sham-Pulsed Radiofrequency treatment will be administered. Subsequently, the injectate will be administered. Dexamethasone is selected as the corticosteroid as it is colorless and will be indistinguishable from the saline used in the Intra-articular Pulsed Radiofrequency and placebo groups.

Conditions

Knee Osteoarthritis

Study Design

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

Study Groups

Active

intra-articular 4 milliliters 0.5% bupivacaine + 10mg dexamethasone + sham Pulsed Radiofrequency

Group Type: ACTIVE_COMPARATOR

Placebo Intra-Articular Injection

Intervention Type: PROCEDURE

Two 20-gauge radiofrequency needle with 10mm active tip will be placed intra-articularly from an anterolateral and anteromedial approach to target the medial and lateral compartments. Once satisfactory fluoroscopic placement is noted, the Placebo Intra-Articular treatment will be administered.

Control

intra-articular 5 milliliters 0.9% saline + sham Pulsed Radiofrequency

Group Type: PLACEBO_COMPARATOR

Standard of Care Intra- Articular Injection

Intervention Type: PROCEDURE

Two 20-gauge radiofrequency needle with 10mm active tip will be placed intra-articularly from an anterolateral and anteromedial approach to target the medial and lateral compartments. Once satisfactory fluoroscopic placement is noted, the Intra-Articular treatment will be administered.

Experimental

intra-articular 5 milliliters 0.5% bupivacaine + Pulsed Radiofrequency

Group Type: EXPERIMENTAL

Pulse Radiofrequency

Intervention Type: PROCEDURE

Two 20-gauge radiofrequency needle with 10mm active tip will be placed intra-articularly from an anterolateral and anteromedial approach to target the medial and lateral compartments. Once satisfactory fluoroscopic placement is noted, the Pulsed Radiofrequency treatment will be administered.

Interventions

Pulse Radiofrequency

Two 20-gauge radiofrequency needle with 10mm active tip will be placed intra-articularly from an anterolateral and anteromedial approach to target the medial and lateral compartments. Once satisfactory fluoroscopic placement is noted, the Pulsed Radiofrequency treatment will be administered.

Intervention Type: PROCEDURE

Standard of Care Intra- Articular Injection

Two 20-gauge radiofrequency needle with 10mm active tip will be placed intra-articularly from an anterolateral and anteromedial approach to target the medial and lateral compartments. Once satisfactory fluoroscopic placement is noted, the Intra-Articular treatment will be administered.

Intervention Type: PROCEDURE

Placebo Intra-Articular Injection

Two 20-gauge radiofrequency needle with 10mm active tip will be placed intra-articularly from an anterolateral and anteromedial approach to target the medial and lateral compartments. Once satisfactory fluoroscopic placement is noted, the Placebo Intra-Articular treatment will be administered.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Capable of giving written informed consent
• Patients aged 18 years or older
• Patients with unilateral or bilateral knee pain for at least 3 months
• Radiographic evidence of knee osteoarthritis
• Appropriate candidate for steroid injection as determined by the investigator

Exclusion Criteria

• Chronic knee pain caused by infection, inflammation, tumors, and fractures
• A history of acute knee pain, previous knee surgery, connective tissue diseases, progressive neurologic disease or uncontrolled psychiatric disorders
• The administration of steroids or hyaluronic acids within the last three months
• Coagulation disorders
• Local infection at the site of intervention planned
• Active litigation related to this pain complaint

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Center For Interventional Pain and Spine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael A Fishman, MD

Role: PRINCIPAL_INVESTIGATOR

Center For Interventional Pain and Spine

Locations

Center for Interventional Pain and Spine

Exton, Pennsylvania, United States

Countries

United States

Other Identifiers

2019IA-PRF

Identifier Type: -

Identifier Source: org_study_id