Osteoarthritis of the KneeNCT01704157
A Prospective Study Evaluating the Treatment of Knee Osteoarthritis With the Cryo-Touch III Device
A study testing Cryo-Touch III in people with Osteoarthritis of the Knee, run by Pacira Pharmaceuticals, Inc at 2 sites in United States.
Trial summary
A proof of concept study to evaluate the feasibility of safe and effective treatment through optimization of the Cryo-Touch III device for temporary relief of pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Cryo-Touch III
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2012to Jul 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18 years of age and older.
- Participants must meet American College of Rheumatology (ACR) criteria for osteoarthritis of the knee (unilateral or bilateral). Clinical criteria includes knee pain and at least three of the following 6 criteria: 50 years of age or older, stiffness lasting less than 30 minutes, crepitus, bony tenderness, bony enlargement, and/or no warmth to the touch.
- Any medications (prescription and/or over-the counter) must be maintained on a stable schedule for ≥ 2 weeks prior to treatment. No washout period is allowed.
- An average Visual Analog Scale (VAS) for pain ≥ 4 over the last 30 days.
- Subject is willing and able to give written informed consent.
- Subject is willing and able to comply with study instructions and commit to all follow-up visits for the duration of the study.
- Subject 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 subject to an unacceptable risk by study participation.
Who cannot join
- A partial or full knee replacement (in the treated knee).
- Any use of systemic injections (in any area) within the last 6 months.
- Current enrollment in an investigational drug or a device study that specifically targets pain treatment.
- Any additional diagnosis that in the opinion of the investigator may directly contribute to knee pain.
- Any concomitant inflammatory disease or other condition that affects the joints (e.g. rheumatoid arthritis, metabolic bones disease, gout, active infection, etc.).
- Any clotting disorder and/or has used an anticoagulant (e.g., warfarin, clopidogrel, etc.) within seven (7) days prior to administration of the device.
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- Allergy or intolerance to lidocaine.
- 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.).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Injury Care Medical Center
Boise, Idaho, 83713
Neurovations
Napa, California, 94557
About this study
Official title: A Prospective Non-Randomized Unblinded Study Evaluating the Treatment of Knee Osteoarthritis With the Cryo-Touch III Device
A proof of concept study to evaluate the feasibility of safe and effective treatment through optimization of the Cryo-Touch III device for temporary relief of pain.
Read the detailed description
Over 100 million patients in the United States suffer from chronic pain. Chronic pain conditions are often debilitating, taking a toll on a patient's physical and mental welfare. Though a variety of pain management techniques currently exist, the most common nonsurgical options provide slow-acting and/or short-term relief. Medication, often in the form of non-steroidal anti-inflammatory drugs (NSAIDs) and opioids, comes with an array of side effects such as nausea and vomiting. Medication also presents the possibility of more serious effects such as increased risk of heart attack and stroke, and tolerance or dependency issues. Surgical strategies tend to be reserved for more severe cases and are limited by the risks and complications typically associated with surgery including bleeding, bruising, scarring, and infection. A nonsurgical, minimally invasive, long-lasting approach to chronic pain management is desirable.
The Cryo-Touch III is a pain management device developed for a novel, minimally invasive procedure using focused cold therapy to target sensory nerve tissue and offer long-lasting pain relief through cryoanalgesia. The device operates on the well-established cryobiology principle that localized exposure to controlled moderately low temperature conditions can alter tissue function. The therapy treats nerves with low temperatures via a cold probe in the form of an assembly of small diameter needles, creating a highly localized treatment zone around the probe. This focused cold therapy creates a conduction block that prevents nerve signaling.
Though studies have proven efficacious in targeting motor nerves, the device's effect on sensory nerves has yet to have been investigated in the clinical setting. The goal of the study described herein is to evaluate the degree and duration of effect of the Cryo-Touch III in reducing chronic pain by targeting sensory nerves.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Cryo-Touch III
- Keywords
- Osteoarthritis, knee, chronic pain
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryo-Touch IIIDevice
Study treatment at Day 0.
| Study group | Role | What they receive |
|---|---|---|
| Open Treatment | Other | Treatment with Cryo-Touch III Device Receives: Device: Cryo-Touch III |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Improvement in VAS Pain Score From Baseline to Day 7
Visual Analog Scale(VAS), where a higher score indicates greater intensity; 0= no pain, 10=worst pain
Measured: Baseline to Day 7
Improvement in WOMAC Index From Baseline to Day 7
The Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain scale.
A tri-dimensional, disease-specific, patient-reported outcome measure. Consists of 24 questions: 5 pain, 2 stiffness and 17 function. Each category contains a set of questions rated by the Subject on a 0-10 scale;
The highest possible score was 50 for pain, 20 for stiffness and 170 for function, based on the 0-10 scale used to assess each question.
The total score range is 0 to 240 with higher scores correlating to worse outcomes.
Measured: Baseline to Day 7
Secondary outcomes (1)
Number of Participants Who Experienced Continued Treatment Effect at Each Time Point
Subjects were asked to report whether they experienced continued treatment effect at the timepoints indicated.
Measured: Visit 3 (Day 7), Visit 4 (Day 30), Visit 5 (Day 56)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionApr 2013
- Study completionJul 2013
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.
- Other trials for Osteoarthritis of the KneeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 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
- NCT01704157
- Sponsor's protocol ID
- MYO-0601
- Other IDs
- Pain-OA
- Status last verified
- Jan 2024
- First submitted
- 5 Oct 2012
- Last updated
- 24 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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 Prospective Non-Randomized Unblinded Study Evaluating the Treatment of Knee Osteoarthritis With the Cryo-Touch III Device
- ClinicalTrials.gov ID
- NCT01704157
- Acronym / sponsor ID
- MYO-0601
- Conditions
- Osteoarthritis of the Knee
- Keywords
- Osteoarthritis, knee, chronic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 11 Oct 2012 (estimated)
- Results
- Posted 29 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A proof of concept study to evaluate the feasibility of safe and effective treatment through optimization of the Cryo-Touch III device for temporary relief of pain.
Detailed description
Over 100 million patients in the United States suffer from chronic pain. Chronic pain conditions are often debilitating, taking a toll on a patient's physical and mental welfare. Though a variety of pain management techniques currently exist, the most common nonsurgical options provide slow-acting and/or short-term relief. Medication, often in the form of non-steroidal anti-inflammatory drugs (NSAIDs) and opioids, comes with an array of side effects such as nausea and vomiting. Medication also presents the possibility of more serious effects such as increased risk of heart attack and stroke, and tolerance or dependency issues. Surgical strategies tend to be reserved for more severe cases and are limited by the risks and complications typically associated with surgery including bleeding, bruising, scarring, and infection. A nonsurgical, minimally invasive, long-lasting approach to chronic pain management is desirable.
The Cryo-Touch III is a pain management device developed for a novel, minimally invasive procedure using focused cold therapy to target sensory nerve tissue and offer long-lasting pain relief through cryoanalgesia. The device operates on the well-established cryobiology principle that localized exposure to controlled moderately low temperature conditions can alter tissue function. The therapy treats nerves with low temperatures via a cold probe in the form of an assembly of small diameter needles, creating a highly localized treatment zone around the probe. This focused cold therapy creates a conduction block that prevents nerve signaling.
Though studies have proven efficacious in targeting motor nerves, the device's effect on sensory nerves has yet to have been investigated in the clinical setting. The goal of the study described herein is to evaluate the degree and duration of effect of the Cryo-Touch III in reducing chronic pain by targeting sensory nerves.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Treatment | Other | Device: Cryo-Touch IIITreatment with Cryo-Touch III Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, 18 years of age and older.
- Participants must meet American College of Rheumatology (ACR) criteria for osteoarthritis of the knee (unilateral or bilateral). Clinical criteria includes knee pain and at least three of the following 6 criteria: 50 years of age or older, stiffness lasting less than 30 minutes, crepitus, bony tenderness, bony enlargement, and/or no warmth to the touch.
- Any medications (prescription and/or over-the counter) must be maintained on a stable schedule for ≥ 2 weeks prior to treatment. No washout period is allowed.
- An average Visual Analog Scale (VAS) for pain ≥ 4 over the last 30 days.
- Subject is willing and able to give written informed consent.
Key exclusion criteria (11 listed)
- A partial or full knee replacement (in the treated knee).
- Any use of systemic injections (in any area) within the last 6 months.
- Current enrollment in an investigational drug or a device study that specifically targets pain treatment.
- Any additional diagnosis that in the opinion of the investigator may directly contribute to knee pain.
- Any concomitant inflammatory disease or other condition that affects the joints (e.g. rheumatoid arthritis, metabolic bones disease, gout, active infection, etc.).
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 |
|---|---|---|
| Cryo-Touch IIIStudy treatment at Day 0. | Device | Open Treatment |
Primary outcome
Average Improvement in VAS Pain Score From Baseline to Day 7
Time frame: Baseline to Day 7
Visual Analog Scale(VAS), where a higher score indicates greater intensity; 0= no pain, 10=worst pain
Improvement in WOMAC Index From Baseline to Day 7
Time frame: Baseline to Day 7
The Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain scale. A tri-dimensional, disease-specific, patient-reported outcome measure. Consists of 24 questions: 5 pain, 2 stiffness and 17 function. Each category contains a set of questions rated by the Subject on a 0-10 scale; The highest possible score was 50 for pain, 20 for stiffness and 170 for function, based on the 0-10 scale used to assess each question. The total score range is 0 to 240 with higher scores correlating to worse outcomes.
1 secondary outcome
Number of Participants Who Experienced Continued Treatment Effect at Each Time Point
Time frame: Visit 3 (Day 7), Visit 4 (Day 30), Visit 5 (Day 56)
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.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryo-Touch III in people with Osteoarthritis of the Knee, run by Pacira Pharmaceuticals, Inc at 2 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 7 inclusion and 11 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 2 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. 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 29 Sep 2023). 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?
Average Improvement in VAS Pain Score From Baseline to Day 7 (time frame: Baseline to Day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.