Clinical trial NCT04238598: Intra-articular Pulsed Radiofrequency Neuromodulation Versus Intra-articular Steroids for Painful Knee Osteoarthritis
Official title: Sham-controlled Randomized Trial of Intra-articular Pulsed Radiofrequency Neuromodulation Versus Intra-articular Steroids for Painful Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Center For Interventional Pain and Spine
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: test, active, control
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Visual Analogue Scale pain scores
timeFrame: 1-week, 1-, 3-, 6-, and 12-months
Secondary outcomes:
measure: Change in Patient-Reported Outcomes Measurement Information System-29 and Western Ontario and McMaster Universities Osteoarthritis (Index)
timeFrame: 1-week, 1-, 3-, 6-, and 12-months
measure: Change in Analgesic use
timeFrame: 1-week, 1-, 3-, 6-, and 12-months
measure: Change in Timed Up and Go Test
timeFrame: 1-week, 1-, 3-, 6-, and 12-months
measure: Change in Progression to Surgery
timeFrame: 1-week, 1-, 3-, 6-, and 12-months
Other outcomes:
Locations:
city: Exton
country: United States
facility: Center for Interventional Pain and Spine
state: Pennsylvania
Study officials:
affiliation: Center For Interventional Pain and Spine
name: Michael A Fishman, MD
role: PRINCIPAL_INVESTIGATOR
References: