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CompletedNCT01704157Updated Jan 24, 2024Results posted

A Prospective Study Evaluating the Treatment of Knee Osteoarthritis With the Cryo-Touch III Device

An interventional study of Cryo-Touch III in Osteoarthritis of the Knee, sponsored by Pacira Pharmaceuticals, Inc. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-24.

Sponsored by Pacira Pharmaceuticals, Inc · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Osteoarthritis of the Knee

Keywords

  • Osteoarthritis
  • knee
  • chronic pain
03

In context

Osteoarthritis

4,399 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.

This study's enrollment of 33 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Pacira Pharmaceuticals, Inc is the lead sponsor of 100 studies on the registry; 3 are open to participants now.

Of its 26 completed or terminated interventional studies of FDA-regulated products, 17 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Other
    Open Treatment

    Treatment with Cryo-Touch III Device

    Device: Cryo-Touch III

Interventions

  • DeviceCryo-Touch III

    Study treatment at Day 0.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline to Day 7

  2. 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.

    Time frame: 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.

    Time frame: Visit 3 (Day 7), Visit 4 (Day 30), Visit 5 (Day 56)

07

Results

Posted Sep 29, 2023

Participant flow

Subjects were prospectively enrolled at 2 sites. Enrollment was initiated September 18, 2012 and completed March 25, 2013.

Participant flow — Overall Study
MilestoneOpen Treatment
Started33
Completed33
Not completed0

Outcome measures

PrimaryAverage 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

Time frame:
Baseline to Day 7
Reported as:
Mean · score on a scale
Average Improvement in VAS Pain Score From Baseline to Day 7
score on a scaleOpen Treatment
Average Improvement in VAS Pain Score From Baseline to Day 72.2 ± 2.2
PrimaryImprovement 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.

Time frame:
Baseline to Day 7
Reported as:
Mean · score on a scale
Improvement in WOMAC Index From Baseline to Day 7
score on a scaleOpen Treatment
Improvement in WOMAC Index From Baseline to Day 785.7 ± 53.4
SecondaryNumber 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.

Time frame:
Visit 3 (Day 7), Visit 4 (Day 30), Visit 5 (Day 56)
Reported as:
Count of participants · Participants
Number of Participants Who Experienced Continued Treatment Effect at Each Time Point
ParticipantsOpen Treatment
Day 731
Day 3028
Day 5623

Adverse events

Collected over Adverse events were collected from treatment day through Day 140. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Open Treatment0/33 (0%)1/33 (3%)9/33 (27.3%)
Most frequent serious events
Most frequent serious events
EventOpen Treatment
TuberculosisInfections and infestations1/33
Most frequent other events
Most frequent other events
EventOpen Treatment
Right leg numbnessNervous system disorders1/33
nausea duringprocedureInjury, poisoning and procedural complications1/33
Seasonal ColdInfections and infestations1/33
Arm LacerationSkin and subcutaneous tissue disorders1/33
Tenderness to palpation in thighMusculoskeletal and connective tissue disorders1/33
clicking sound in knee with standingMusculoskeletal and connective tissue disorders1/33
tingling/pain in feetNervous system disorders1/33
Left Leg numbnessNervous system disorders1/33
Pain/loss of full range of motion with pivotMusculoskeletal and connective tissue disorders1/33

Baseline characteristics

Age, Continuous
Age, Continuous(years)Open Treatment
Mean55.9 ± 11.6
Sex: Female, Male
Sex: Female, Male(Participants)Open Treatment
Gender — Female12
Gender — Male21
Region of Enrollment
Region of Enrollment(participants)Open Treatment
United States33
Average Baseline Pain Score- Visual Analog Scale (VAS)
Average Baseline Pain Score- Visual Analog Scale (VAS)(units on a scale)Open Treatment
Mean6.3 ± 1.6
Average Baseline Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain scale
Average Baseline Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain scale(units on a scale)Open Treatment
Mean125.8 ± 42.8
08

Study locations

2 sites
  • Neurovations
    Napa, California 94557, United States
  • Injury Care Medical Center
    Boise, Idaho 83713, United States
09

References and documents

Study documents

  • Study protocol · Jun 25, 2013

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01704157
Lead sponsor
Pacira Pharmaceuticals, Inc
Responsible party
Sponsor
First posted
Oct 11, 2012
Start date
Sep 2012
Primary completion
Apr 2013
Completion
Jul 2013
Results posted
Sep 29, 2023
Last update
Jan 24, 2024

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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