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

Center For Interventional Pain and Spine

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Procedure: Standard of Care Intra- Articular Injection; Procedure: Pulse Radiofrequency; Procedure: Placebo Intra-Articular Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04238598

2019IA-PRF

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 3 patient groups, including a placebo group

Active

Active Comparator group

Description:

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

Treatment:

Procedure: Placebo Intra-Articular Injection

Control

Placebo Comparator group

Description:

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

Treatment:

Procedure: Standard of Care Intra- Articular Injection

Experimental

Experimental group

Description:

intra-articular 5 milliliters 0.5% bupivacaine + Pulsed Radiofrequency

Treatment:

Procedure: Pulse Radiofrequency