An interventional study of Pulse Radiofrequency and Standard of Care Intra- Articular Injection in Knee Osteoarthritis, sponsored by Center For Interventional Pain and Spine. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-30.
Sponsored by Center For Interventional Pain and Spine · Not applicable, Interventional, and Treatment
To compare the efficacy of intra-articular pulsed radiofrequency to intra-articular steroids in patients with moderate-severe painful osteoarthritis of the knee.
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.
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 30 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Center For Interventional Pain and Spine is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
intra-articular 4 milliliters 0.5% bupivacaine + 10mg dexamethasone + sham Pulsed Radiofrequency
Procedure: Placebo Intra-Articular Injection
intra-articular 5 milliliters 0.9% saline + sham Pulsed Radiofrequency
Procedure: Standard of Care Intra- Articular Injection
intra-articular 5 milliliters 0.5% bupivacaine + Pulsed Radiofrequency
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.
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.
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.
Change in Visual Analogue Scale pain scores
Evaluates the level of pain. Minimum=0 Maximum=10, Larger number indicates worse outcome
Time frame: 1-week, 1-, 3-, 6-, and 12-months
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
Time frame: 1-week, 1-, 3-, 6-, and 12-months
Change in Analgesic use
Evaluates number of medications, doses of medications
Time frame: 1-week, 1-, 3-, 6-, and 12-months
Change in Timed Up and Go Test
Evaluates physical mobility
Time frame: 1-week, 1-, 3-, 6-, and 12-months
Change in Progression to Surgery
Evaluates effectiveness of treatment
Time frame: 1-week, 1-, 3-, 6-, and 12-months
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Center For Interventional Pain and Spine