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

Knee Osteoarthritis Clinical Trial

Official title:

Sham-controlled Randomized Trial of Intra-articular Pulsed Radiofrequency Neuromodulation Versus Intra-articular Steroids for Painful Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04238598
• Other study ID #: 2019IA-PRF
• Status: Completed
• Phase: N/A
• Start date: October 8, 2019
• Est. completion date: September 1, 2021

Study information

• Verified date: March 2023
• Source: Center For Interventional Pain and Spine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 1, 2021
• Est. primary completion date: January 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Center for Interventional Pain and Spine	Exton	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Center For Interventional Pain and Spine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Visual Analogue Scale pain scores	Evaluates the level of pain. Minimum=0 Maximum=10, Larger number indicates worse outcome	1-week, 1-, 3-, 6-, and 12-months
Secondary	Change in Patient-Reported Outcomes Measurement Information System-29 and Western Ontario and McMaster Universities Osteoarthritis (Index)	Evaluates level of pain. For Patient-Reported Outcomes Measurement Information System-29, Minimum= 8 and Maximum=40. For Western Ontario and McMaster Universities Osteoarthritis (Index), Minimum=0 Maximum=20. Larger number indicates worse outcome	1-week, 1-, 3-, 6-, and 12-months
Secondary	Change in Analgesic use	Evaluates number of medications, doses of medications	1-week, 1-, 3-, 6-, and 12-months
Secondary	Change in Timed Up and Go Test	Evaluates physical mobility	1-week, 1-, 3-, 6-, and 12-months
Secondary	Change in Progression to Surgery	Evaluates effectiveness of treatment	1-week, 1-, 3-, 6-, and 12-months