Diagnostic Genicular Nerve Block Prior to Radiofrequency Ablation for Knee Osteoarthritis Pain

NCT02578108 | Completed DMC

• 1 other identifier: STU00201206
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic painful knee OA is a major cause of disability in older adults. In patients whose symptoms are refractory to conservative management but who do not wish to undergo TKA or, alternatively, are not operative candidates, genicular nerve RFA represents a promising treatment option. Investigators will determine if patients with chronic painful knee osteoarthritis experience meaningful and long-term improvement in pain, function, and analgesic use, as well as prevention of TKA after RFA of the genicular nerves. Investigators will also determine whether zero versus one set of diagnostic genicular nerve blocks Answering these questions will help determine if genicular nerve RFA is indeed a worthwhile treatment for chronic painful knee OA. Additionally, this will help determine the optimal diagnostic protocol for patient selection for this procedure, which has implications for improving treatment success rates, preventing unnecessary procedures, and decreasing healthcare cost savings.

Conditions

Osteoarthritis, Knee; Pain; Nerve; Lesion

Outcome Measures

Primary Outcomes (1)

• >50% relief of pain from before to after radiofrequency ablation of the genicular nerves

  Outcomes will be compared between those who received a set of diagnostic blocks and those who did not receive a set of diagnostic blocks (arm 1 vs. arm 2)

  6 months

Secondary Outcomes (1)

• Mean reduction in morphine equivalent use for knee pain from before to after radiofrequency ablation of the genicular nerves

  6 months

Study Arms (2)

no diagnostic genicular nerve blocks

ACTIVE COMPARATOR

no diagnostic genicular nerve blocks prior to genicular nerve ablation Intervention: genicular nerve radiofrequency ablation

Procedure: genicular nerve radiofrequency ablation

diagnostic genicular nerve blocks

ACTIVE COMPARATOR

Set of diagnostic genicular nerve blocks prior to genicular nerve ablation Intervention: genicular nerve radiofrequency ablation

Procedure: genicular nerve diagnostic block with lidocaine (local anesthetic); Procedure: genicular nerve radiofrequency ablation

Interventions

genicular nerve diagnostic block with lidocaine (local anesthetic) PROCEDURE

sensory denervation of the knee joint

diagnostic genicular nerve blocks

genicular nerve radiofrequency ablation PROCEDURE

Ablation of the genicular nerves of the knee by radiofrequency energy

diagnostic genicular nerve blocks; no diagnostic genicular nerve blocks

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients ages 30-80 with chronic painful knee osteoarthritis who would undergo treatment by genicular nerve radiofrequency ablation.
• Knee pain for at least 6 months.
• Kellgren-Lawrence knee osteoarthritis of 2 or greater.
• Pain resistant to conventional therapy including NSAIDs, opioids, muscle relaxants, oral steroids, physical therapy, and intra-articular injection therapy.
• No pain referral beyond the expected distribution for knee osteoarthritis.

You may not qualify if:

• NRS pain score of 4 or more
• Focal neurologic signs or symptoms.
• Previous radiofrequency ablation treatment for similar symptoms.
• Intra-articular knee corticosteroid or hyaluronic acid injection in the past 3 months.
• Concomitant radicular pain.
• Previous knee surgery.
• Patient refusal.
• Lack of consent.
• Active systemic or local infections at the site of proposed needle and electrode placement.
• Coagulopathy or other bleeding disorder, current use of anticoagulants or anti-platelet medications.
• Allergy to medications being used for injection procedures (contrast, local anesthetic).
• Inability to read English, communicate with staff, or participate in follow-up.
• Pregnancy.
• Pacemaker.
• Cognitive deficit.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Interventions

Lidocaine; Anesthetics, Local

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Zachary McCormick, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: October 16, 2015
• Study Start: October 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: August 21, 2019

Record last verified: 2017-09

Locations

US (1)