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Completed

NCT Number: NCT04238598

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

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

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Interventional Pain and Spine

Exton, Pennsylvania, 19341, United States

About this study

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.

  • Active control - intra-articular 4 milliliters 0.5% bupivacaine + 10mg dexamethasone + sham Pulsed Radiofrequency
  • Placebo control - intra-articular 5 milliliters 0.9% saline + sham Pulsed Radiofrequency
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulse Radiofrequency

Procedure

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

Procedure

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

Procedure

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.

Primary outcomes

  1. Change in Visual Analogue Scale pain scores

    Time frame: 1-week, 1-, 3-, 6-, and 12-months

    Evaluates the level of pain. Minimum=0 Maximum=10, Larger number indicates worse outcome

Secondary outcomes

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

    Time frame: 1-week, 1-, 3-, 6-, and 12-months

    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

  2. Change in Analgesic use

    Time frame: 1-week, 1-, 3-, 6-, and 12-months

    Evaluates number of medications, doses of medications

  3. Change in Timed Up and Go Test

    Time frame: 1-week, 1-, 3-, 6-, and 12-months

    Evaluates physical mobility

  4. Change in Progression to Surgery

    Time frame: 1-week, 1-, 3-, 6-, and 12-months

    Evaluates effectiveness of treatment

Sponsors and collaborators

Lead sponsor

Center For Interventional Pain and Spine

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 23, 2020
Registry last updated
Mar 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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