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

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ClinicalTrials.gov Identifier: NCT02260921
Recruitment Status : Completed
First Posted : October 9, 2014
Results First Posted : December 31, 2020
Last Update Posted : February 2, 2021
Sponsor:
Information provided by (Responsible Party):
Pacira CryoTech, Inc., a wholly owned subsidiary of Pacira BioSciences, Inc.

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Device: iovera° Device: Sham Comparator Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Center, Prospective, Double-Blind, Randomized Controlled Study to Evaluate the Effectiveness and Safety of the Iovera° Device for the Temporary Relief of Pain Associated With Knee Osteoarthritis
Actual Study Start Date : October 20, 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : May 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: iovera° Treatment
Treatment with the iovera° device administered by a trained investigator to treat knee pain.
Device: iovera°
Sham Comparator: Sham Treatment
Sham Treatment (similar device with no active therapeutic treatment) administered by a trained investigator to treat knee pain.
Device: Sham Comparator



Primary Outcome Measures :
  1. Absolute Change From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscale Score at Day 30 [ Time Frame: Baseline to 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.


Secondary Outcome Measures :
  1. Change From Baseline in Visual Analog Scale (VAS) at Day 30 [ Time Frame: Baseline to Day 30 ]
    VAS pain assessment is a measure of pain intensity. The scale is made up of a 10 centimeter (cm) [100 millimeter (mm)] horizontal line. The far left of the horizontal line is labeled "no pain" while the far right of the horizontal line is labeled "worst imaginable pain". A negative change from Baseline indicates improvement. An ANCOVA model was used for analyses.

  2. Change From Baseline in Total WOMAC Score at Day 30 [ Time Frame: Baseline to 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]. The WOMAC total score was calculated by summing the 3 subscales for a total possible score of 0 to 240. A negative change from Baseline indicates improvement. An ANCOVA model was used for analyses.

  3. Change From Baseline in VAS at Day 60 [ Time Frame: Baseline to Day 60 ]
    VAS pain assessment is a measure of pain intensity. The scale is made up of a 10 cm (100 mm) horizontal line. The far left of the horizontal line is labeled "no pain" while the far right of the horizontal line is labeled "worst imaginable pain". A negative change from Baseline indicates improvement. An ANCOVA model was used for analyses.

  4. WOMAC Pain Score Responder Rate at Day 30 [ Time Frame: Day 30 ]
    WOMAC Pain Score Responder Rate is defined as the percentage of participants with at least a 30% reduction in the WOMAC pain score at Day 30 compared to Baseline. 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 to 10= Extreme] with the first 5 questions regarding pain [possible subscale score 0 (best) to 50 (worst)].

  5. VAS Responder Rate at Day 30 [ Time Frame: Day 30 ]
    VAS Responder Rate is defined as the percentage of participants with at least a 30% reduction in VAS at Day 30 compared to Baseline VAS pain assessment is a measure of pain intensity. The scale is made up of a 10 cm (100 mm) horizontal line. The far left of the horizontal line is labeled "no pain" while the far right of the horizontal line is labeled "worst imaginable pain".

  6. Change From Baseline in Total WOMAC Score at Day 60 [ Time Frame: Baseline to Day 60 ]
    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]. The WOMAC total score was calculated by summing the 3 subscales for a total possible score of 0 to 240. A negative change from Baseline indicates improvement.

  7. VAS Responder Rate at Day 60 [ Time Frame: Day 60 ]
    VAS Responder Rate is defined as the percentage of participants with at least a 30% reduction in VAS at Day 60 compared to Baseline. VAS pain assessment is a measure of pain intensity. The scale is made up of a 10 cm (100 mm) horizontal line. The far left of the horizontal line is labeled "no pain" while the far right of the horizontal line is labeled "worst imaginable pain".

  8. WOMAC Pain Score Responder Rate at Day 60 [ Time Frame: Day 60 ]
    WOMAC Pain Score Responder Rate is defined as the percentage of participants with at least a 30% reduction in the WOMAC pain score at Day 60 compared to Baseline. 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 the first 5 questions regarding pain [possible subscale score 0 to 50].



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 35 - 75 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.
  • Participant is in good general health and free of any systemic disease state or physical condition that might impair evaluation or which in the Investigator's opinion, exposes the Participant to an unacceptable risk by study participation.

Exclusion Criteria:

  • 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.
  • History of cryoglobulinemia
  • History of paroxysmal cold hemoglobinuria.
  • History of cold urticaria.
  • History of Raynaud's disease.
  • History of pes anserinus bursitis in the knee to be treated.
  • Use of extended-release or long-acting opioids within previous 3 months.
  • Use of immediate-release opioids for more than 3 days per week within previous month.
  • Participant is pregnant or planning to become pregnant while enrolled in the study.
  • Current enrollment in any investigational drug or device study or participation within 30 days prior to screening.
  • Any additional diagnosis that in the opinion of the Investigator directly contributes to knee pain.
  • Any concomitant inflammatory disease or other condition that affects the joints (e.g. rheumatoid arthritis, metabolic bone disease, gout, active infection, etc.)
  • Any clotting disorder and/or use of an anticoagulant (e.g., aspirin, warfarin, clopidogrel, etc.) within seven (7) days prior to administration of the device.
  • Any local skin condition at the treatment site that in the Investigator's opinion would adversely affect treatment or outcomes.
  • Any chronic medical condition that in the Investigator's opinion would prevent adequate participation.
  • Any chronic medication use (prescription, over-the-counter, etc.) that in the Investigator's opinion would affect study participation or Subject safety.
  • For any reason, in the opinion of the Investigator, the Subject may not be a suitable candidate for study participation (i.e., history of noncompliance, drug dependency, any related knee injury due to a worker's compensation claim, etc.).
  • Known liver dysfunction.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02260921


Locations
Show Show 17 study locations
Sponsors and Collaborators
Pacira CryoTech, Inc., a wholly owned subsidiary of Pacira BioSciences, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pacira CryoTech, Inc., a wholly owned subsidiary of Pacira BioSciences, Inc.
ClinicalTrials.gov Identifier: NCT02260921    
Other Study ID Numbers: MYO-0946
First Posted: October 9, 2014    Key Record Dates
Results First Posted: December 31, 2020
Last Update Posted: February 2, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases