Nerve Ablation by Cooled Radiofrequency Compared to Corticosteroid Injection for Management of Knee Pain

NCT02343003 | Completed Results

• 1 other identifier: 105-14-0001
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 11

Brief Summary

This study is designed to:

• Determine the effectiveness (primarily measured by pain relief) of Coolief when used to create radiofrequency lesions of the genicular nerves compared to pain relief following corticosteroid injection; and
• Confirm the safety of Coolief when used to perform radiofrequency lesions of the genicular nerves in subjects to manage knee pain compared to safety of corticosteroid injection

Conditions

Osteoarthritis of the Knee

Keywords

cooled radiofrequency ablation; knee pain; osteoarthritis; pain management

Outcome Measures

Primary Outcomes (2)

• Numeric Rating Scale (NRS)

  The number of subjects whose knee pain is reduced by ≥ 50% based on the Numeric Rating Scale (NRS). The NRS is an 11-point scale (0 points to 10 points), where 0 points equals "no pain" and 10 points equals the "worst pain".

  6 months

• Safety: Number of Subjects Experiencing Adverse Events Through Final Follow up.

  Safety Endpoint: Number of subjects experiencing adverse events through final follow up.

  6 months and 12 months

Secondary Outcomes (2)

• Numeric Rating Scale

  12 months

• Oxford Knee Score

  6 months and 12 months

Other Outcomes (2)

• Subject Satisfaction - Number of Participants With a Global Perceived Effect Score of 5 or Greater

  6 months and 12 months

• Medication Usage

  6 months and 12 months

Study Arms (2)

Cooled radiofrequency

EXPERIMENTAL

Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain

Device: Cooled Radiofrequency

Corticosteroid injection

ACTIVE COMPARATOR

Corticosteroid injections will be administered to study subjects' knees to reduce knee pain

Drug: Corticosteroid injection

Interventions

Cooled Radiofrequency DEVICE

Delivery of energy to ablate sensory nerves via cooled radiofrequency probe

Also known as: Coolief

Cooled radiofrequency

Corticosteroid injection DRUG

Delivery of corticosteroid into knee by injection with needle to reduce knee pain

Corticosteroid injection

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 21 years
• Able to understand the informed consent form and provide written informed consent and able to complete outcome measures
• History of chronic knee pain for longer than 6 months unresponsive to conservative treatments (PT, oral analgesics, intra-articular injections with steroids and/or viscosupplementation)
• Positive response (defined as a decrease in numeric pain scores of at least 50%) to a geniculate nerve block of the index knee
• Pain on NRS ≥ 6 on a 10 point scale for the index knee
• Radiologic confirmation of osteoarthritis (x-ray/MRI/CT) of OA grade of 2 (mild), 3 (moderate) or 4 (severe) noted within 12 months for the index knee
• Oxford Knee Score group at Baseline of ≤ 35 indicating moderate to severe OA in the index knee
• If the patient is taking an opioid or other morphine equivalent medication, the dose must be considered clinically stable (defined as \<10% change in dosage for ≥ 2 months prior to the screening visit).
• Analgesics including membrane stabilizers such as Neurontin and antidepressants for pain such as Cymbalta must be clinically stable (defined as stable dosage for ≥ 6 weeks prior to the screening visit) and shall not change during the course of the study without approval of investigator. Agree to see one pain doctor (study investigator) for knee pain during the study period
• Index knee pathology that is consistent with generally accepted indications for total knee arthroplasty.
• Willing to delay any surgical intervention for the index knee for 12 months.
• Willingness to provide informed consent and to comply with the requirements of this protocol for the full duration.

You may not qualify if:

• Pseudo arthritis, rheumatoid arthritis or other systemic inflammatory arthritis condition that could cause knee pain.
• Previous or pending lower limb amputation.
• Intra-articular steroid, platelet rich plasma (PRP) or hyaluronic acid injections in the index knee within 90 days from the screening visit.
• An intra-articular corticosteroid injection is not indicated as an appropriate treatment option.
• Prior radiofrequency of the genicular nerves of the index knee.
• Prior partial, resurfacing, or total knee arthroplasty in index knee.
• Clinically significant ligamentous laxity of the index knee.
• Evidence of structural abnormality other than osteoarthritis of knee, hip or back that materially affects gait or function of the knee or is the underlying cause of the knee pain.
• BMI \> 40.
• Extremely thin patients and those with minimal subcutaneous tissue thickness that would not accommodate a lesion of up to 14 mm in diameter to limit the risk of skin burns.
• Pending or active compensation claim, litigation or disability remuneration (secondary gain) related to knee.
• Pregnant or intent of becoming pregnant during the study period.
• Chronic pain associated with significant psychosocial dysfunction.
• Beck's Depression Index score of \> 22 (indicates clinically depressed state).
• Allergies to any of the medications to be used during the procedure.

Sponsors & Collaborators

• Halyard Health: lead

Study Sites (11)

Valley Anesthesiology Consultants - Estrella

Phoenix, Arizona, 85037, United States

Location

Valley Anesthesiology Consultants/Valley Pain Consultants

Scottsdale, Arizona, 85254, United States

Location

Orthopedic Pain Specialists

Santa Monica, California, 90403, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MAPS Applied Research Center, Inc.

Maple Grove, Minnesota, 55369, United States

Location

Ainsworth Institute of Pain Management

New York, New York, 10022, United States

Location

Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Drexel University

Philadelphia, Pennsylvania, 19104, United States

Location

Piedmont Comprehensive Pain Management

Greenville, South Carolina, 29622, United States

Location

Virginia iSpine Physicians

Richmond, Virginia, 23235, United States

Location

Advanced Pain Management

Greenfield, Wisconsin, 53221, United States

Location

Related Publications (2)

• Davis T, Loudermilk E, DePalma M, Hunter C, Lindley DA, Patel N, Choi D, Soloman M, Gupta A, Desai M, Cook E, Kapural L. Twelve-month analgesia and rescue, by cooled radiofrequency ablation treatment of osteoarthritic knee pain: results from a prospective, multicenter, randomized, cross-over trial. Reg Anesth Pain Med. 2019 Feb 16:rapm-2018-100051. doi: 10.1136/rapm-2018-100051. Online ahead of print.

  PMID: 30772821 DERIVED

• Davis T, Loudermilk E, DePalma M, Hunter C, Lindley D, Patel N, Choi D, Soloman M, Gupta A, Desai M, Buvanendran A, Kapural L. Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis. Reg Anesth Pain Med. 2018 Jan;43(1):84-91. doi: 10.1097/AAP.0000000000000690.

  PMID: 29095245 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Agnosia

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: David Curd
• Organization: Halyard Health

david.curd@hyh.com

470-448-5178

Study Officials

• David T Curd, MS

  Halyard Health, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: January 21, 2015
• Study Start: January 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: March 16, 2017
• Last Updated: May 13, 2019
• Results First Posted: October 9, 2017

Record last verified: 2017-02

Locations

US (11)