Study to Evaluate the Iovera° Device for Temporary Relief From Knee Pain

NCT02260921 | Completed Results FDA Device

• 1 other identifier: MYO-0946
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 17

Brief Summary

This purpose of this study is to evaluate the effectiveness and safety of the iovera° device for the temporary reduction of pain associated with knee osteoarthritis.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Absolute Change From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscale Score at Day 30

  The WOMAC is a tri-dimensional, disease-specific, patient-reported outcome measure. It consists of 24 questions \[each question is presented in a numerical rating scale format with possible values between 0= No (best) to 10= Extreme (worst)\] with 5 questions regarding pain \[possible subscale score 0 to 50\], 2 questions regarding stiffness \[possible subscale score 0 to 20\] and 17 questions regarding function difficulty \[possible subscale score 0 to 170\]. A negative change from Baseline indicates improvement. An Analysis of Covariance (ANCOVA) model was used for analyses.

  Baseline to Day 30

Secondary Outcomes (8)

• Change From Baseline in Visual Analog Scale (VAS) at Day 30

  Baseline to Day 30

• Change From Baseline in Total WOMAC Score at Day 30

  Baseline to Day 30

• Change From Baseline in VAS at Day 60

  Baseline to Day 60

• WOMAC Pain Score Responder Rate at Day 30

  Day 30

• VAS Responder Rate at Day 30

  Day 30

Study Arms (2)

iovera° Treatment

EXPERIMENTAL

Treatment with the iovera° device administered by a trained investigator to treat knee pain.

Device: iovera°

Sham Treatment

SHAM COMPARATOR

Sham Treatment (similar device with no active therapeutic treatment) administered by a trained investigator to treat knee pain.

Device: Sham Comparator

Interventions

iovera° DEVICE

iovera° Treatment

Sham Comparator DEVICE

Sham Treatment

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• American College of Rheumatology (ACR) criteria for osteoarthritis of the knee. This includes radiographic evidence of osteophytes and at least one of the following: age ≥ 50 years old, morning stiffness ≤ 30 minute duration or crepitus on motion.
• Grade II or III osteoarthritis of the knee as determined by Kellgren-Lawrence classification grading scale on anteroposterior (AP) x-ray within previous 6 months.
• Participants are ambulatory without assistive devices.
• Knee pain of ≥ 40 mm on Visual Analog Scale (VAS) when performing one of two movements that elicit the worst pain: standing from a seated position or walking up/down stairs.
• Participant reports knee pain in the anterior and/or inferior aspect of the knee as documented on the knee pain map in the appropriate areas.
• A diagnostic lidocaine (without epinephrine) block of the infrapatellar branch of the saphenous nerve results in a 50% reduction in the VAS pain assessment score when performing the activity that elicits the worst pain: standing from a seated position or walking up/down stairs.
• Participant is able to tolerate a washout of prescription and over-the-counter pain relief for a duration of 5 times the half-life of the medication prior to the Baseline visit.
• Participant is able to tolerate a washout of adjunctive therapies for knee pain for 72 hours prior to the Baseline visit.
• Western Ontario and McMaster Osteoarthritis Index (WOMAC) NRS3.1 Pain subscore ≥ 20 at Baseline/Visit 2.
• Participant is able to tolerate discontinuation of all pain medication throughout the duration of the study. Acetaminophen may be used as rescue medication with a maximum dose of 4g per day.
• Participant is able to tolerate discontinuation of rescue medication, acetaminophen, for 24 hours prior to all follow-up visits.
• Prescription and over-the-counter pain medications must be maintained on a stable schedule for at least two weeks prior to screening.
• Participant is willing and able to give written informed consent.
• Participant is willing and able to comply with study instructions and commit to all follow-up visits for the duration of the study.

You may not qualify if:

• History of a partial or full knee replacement of the knee to be treated.
• Planned partial or full knee replacement within the next 12 months in knee to be treated.
• Previous myoscience Focused Cold Therapy\^TM (FCTTM) treatment.
• Viscosupplementation within the previous 6 months in knee to be treated.
• Participant reports the majority of knee pain outside of the anterior/inferior aspect of the knee.
• Intra-articular steroid injection in the knee to be treated within previous 3 months.
• Gross deformity of the knee including varus or valgus.
• Started physical therapy of the knee to be treated within 3 months of screening.
• Received acupuncture for knee pain within 3 months prior to screening.
• Body Mass Index ≥ 35.
• Prior surgery in the treatment area that may alter the anatomy of the infrapatellar branch of the saphenous nerve or result in scar tissue in the treatment area.
• Open and/or infected wound in the treatment area.
• Disease of the spine, hip, contralateral knee or other lower extremity joint of sufficient degree affecting the assessment of the treated knee.
• Acetaminophen intolerance or allergy.
• Allergy to lidocaine.

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (17)

Medvin Clinical Research

Covina, California, 91723, United States

Location

UC Davis Center for Musculoskeletal Health

Sacramento, California, 95817, United States

Location

Coastal Orthopedics and Sports Medicine of Southwest Florida, PA

Bradenton, Florida, 34203, United States

Location

Shrock Orthpedic Research

Fort Lauderdale, Florida, 33316, United States

Location

Health Awareness

Jupiter, Florida, 33458, United States

Location

JM Clinical Research

South Miami, Florida, 33143, United States

Location

Injury Care Medical Center

Boise, Idaho, 83713, United States

Location

Rockford Orthopedic Associates, LTD

Rockford, Illinois, 61114, United States

Location

Kansas University Medical Center

Fairway, Kansas, 66205, United States

Location

Kansas City Bone and Joint Clinic

Overland Park, Kansas, 66211, United States

Location

Covington Orthopedic and Sports Medicine Institute

Covington, Louisiana, 70433, United States

Location

LHU HSC Department of Orthopaedics

New Orleans, Louisiana, 70112, United States

Location

Arthritis Treatment Center

Frederick, Maryland, 21702, United States

Location

Triangle Orthopaedic Associates, P.A.

Durham, North Carolina, 27704, United States

Location

Blair Orthopedic Associates, Inc.

Altoona, Pennsylvania, 16602, United States

Location

PCET Research Center

Knoxville, Tennessee, 37909, United States

Location

Spokane Joint Replacement Center

Spokane, Washington, 99218, United States

Location

Related Publications (1)

• Radnovich R, Scott D, Patel AT, Olson R, Dasa V, Segal N, Lane NE, Shrock K, Naranjo J, Darr K, Surowitz R, Choo J, Valadie A, Harrell R, Wei N, Metyas S. Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial. Osteoarthritis Cartilage. 2017 Aug;25(8):1247-1256. doi: 10.1016/j.joca.2017.03.006. Epub 2017 Mar 20.

  PMID: 28336454 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Director of Clinical
• Organization: Myoscience

5109331541

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2014
• First Posted: October 9, 2014
• Study Start: October 20, 2014
• Primary Completion: February 1, 2016
• Study Completion: May 31, 2016
• Last Updated: January 24, 2024
• Results First Posted: December 31, 2020

Record last verified: 2024-01

Locations

US (17)