Knee OsteoarthritisNCT02260921
Study to Evaluate the Iovera° Device for Temporary Relief From Knee Pain
A study testing iovera° in people with Knee Osteoarthritis, run by Pacira Pharmaceuticals, Inc at 17 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- iovera°
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 17 sitesUnited States
- Study dates
- 20 Oct 2014to 31 May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Blair Orthopedic Associates, Inc.
Altoona, Pennsylvania, 16602
Injury Care Medical Center
Boise, Idaho, 83713
Coastal Orthopedics and Sports Medicine of Southwest Florida, PA
Bradenton, Florida, 34203
Medvin Clinical Research
Covina, California, 91723
Covington Orthopedic and Sports Medicine Institute
Covington, Louisiana, 70433
Triangle Orthopaedic Associates, P.A.
Durham, North Carolina, 27704
Kansas University Medical Center
Fairway, Kansas, 66205
Shrock Orthpedic Research
Fort Lauderdale, Florida, 33316
Arthritis Treatment Center
Frederick, Maryland, 21702
Health Awareness
Jupiter, Florida, 33458
PCET Research Center
Knoxville, Tennessee, 37909
LHU HSC Department of Orthopaedics
New Orleans, Louisiana, 70112
Kansas City Bone and Joint Clinic
Overland Park, Kansas, 66211
Rockford Orthopedic Associates, LTD
Rockford, Illinois, 61114
UC Davis Center for Musculoskeletal Health
Sacramento, California, 95817
JM Clinical Research
South Miami, Florida, 33143
Spokane Joint Replacement Center
Spokane, Washington, 99218
About this study
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
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
- Being tested
- iovera°, Sham Comparator
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iovera°Device
Sham ComparatorDevice
| Study group | Role | What they receive |
|---|---|---|
| iovera° Treatment | Experimental | Treatment with the iovera° device administered by a trained investigator to treat knee pain. Receives: Device: iovera° |
| Sham Treatment | Sham comparator | Sham Treatment (similar device with no active therapeutic treatment) administered by a trained investigator to treat knee pain. Receives: Device: Sham Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Day 30
Secondary outcomes (8)
Change From Baseline in Visual Analog Scale (VAS) at 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.
Measured: Baseline to Day 30
Change From Baseline in Total WOMAC 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]. 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.
Measured: Baseline to Day 30
Change From Baseline in VAS at 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.
Measured: Baseline to Day 60
WOMAC Pain Score Responder Rate at 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)].
Measured: Day 30
VAS Responder Rate at 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".
Measured: Day 30
Change From Baseline in Total WOMAC Score at 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.
Measured: Baseline to Day 60
VAS Responder Rate at 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".
Measured: Day 60
WOMAC Pain Score Responder Rate at 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].
Measured: Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study start20 Oct 2014
- Primary completionFeb 2016
- Study completion31 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02260921
- Sponsor's protocol ID
- MYO-0946
- Status last verified
- Jan 2024
- First submitted
- 3 Oct 2014
- Last updated
- 24 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 28336454
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02260921
- Acronym / sponsor ID
- MYO-0946
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2014 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- 31 May 2016 (actual)
- First posted
- 9 Oct 2014 (estimated)
- Results
- Posted 31 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iovera° Treatment | Experimental | Device: iovera°Treatment with the iovera° device administered by a trained investigator to treat knee pain. |
| Sham Treatment | Sham comparator | Device: Sham ComparatorSham Treatment (similar device with no active therapeutic treatment) administered by a trained investigator to treat knee pain. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (32 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iovera° | Device | iovera° Treatment |
| Sham Comparator | Device | Sham Treatment |
Primary outcome
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.
8 secondary outcomes
Change From Baseline in Visual Analog Scale (VAS) at Day 30
Time frame: Baseline to Day 30
Change From Baseline in Total WOMAC Score at Day 30
Time frame: Baseline to Day 30
Change From Baseline in VAS at Day 60
Time frame: Baseline to Day 60
WOMAC Pain Score Responder Rate at Day 30
Time frame: Day 30
VAS Responder Rate at Day 30
Time frame: Day 30
Change From Baseline in Total WOMAC Score at Day 60
Time frame: Baseline to Day 60
VAS Responder Rate at Day 60
Time frame: Day 60
WOMAC Pain Score Responder Rate at Day 60
Time frame: Day 60
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28336454Radnovich 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iovera° in people with Knee Osteoarthritis, run by Pacira Pharmaceuticals, Inc at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02260921, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.