NCT04238598

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 8, 2019

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

March 30, 2023

Status Verified

March 1, 2023

Enrollment Period

1.3 years

First QC Date

October 25, 2019

Last Update Submit

March 29, 2023

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in Patient-Reported Outcomes Measurement Information System-29 and Western Ontario and McMaster Universities Osteoarthritis (Index)

    1-week, 1-, 3-, 6-, and 12-months

  • Change in Analgesic use

    1-week, 1-, 3-, 6-, and 12-months

  • Change in Timed Up and Go Test

    1-week, 1-, 3-, 6-, and 12-months

  • Change in Progression to Surgery

    1-week, 1-, 3-, 6-, and 12-months

Study Arms (3)

Active

ACTIVE COMPARATOR

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

Procedure: Placebo Intra-Articular Injection

Control

PLACEBO COMPARATOR

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

Procedure: Standard of Care Intra- Articular Injection

Experimental

EXPERIMENTAL

intra-articular 5 milliliters 0.5% bupivacaine + Pulsed Radiofrequency

Procedure: Pulse Radiofrequency

Interventions

Pulse RadiofrequencyPROCEDURE

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.

Experimental
Standard of Care Intra- Articular InjectionPROCEDURE

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.

Control
Placebo Intra-Articular InjectionPROCEDURE

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.

Active

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Interventional Pain and Spine

Exton, Pennsylvania, 19341, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Michael A Fishman, MD

    Center For Interventional Pain and Spine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: test, active, control
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2019

First Posted

January 23, 2020

Study Start

October 8, 2019

Primary Completion

January 19, 2021

Study Completion

September 1, 2021

Last Updated

March 30, 2023

Record last verified: 2023-03

Locations

US(1)