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

NCT01704157 | Completed Results

• 2 other identifiers: MYO-0601Pain-OA
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Osteoarthritis of the Knee

Keywords

Osteoarthritis; knee; chronic pain

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Baseline to Day 7

Secondary Outcomes (1)

• Number of Participants Who Experienced Continued Treatment Effect at Each Time Point

  Visit 3 (Day 7), Visit 4 (Day 30), Visit 5 (Day 56)

Study Arms (1)

Open Treatment

OTHER

Treatment with Cryo-Touch III Device

Device: Cryo-Touch III

Interventions

Cryo-Touch III DEVICE

Study treatment at Day 0.

Open Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (2)

Neurovations

Napa, California, 94557, United States

Location

Injury Care Medical Center

Boise, Idaho, 83713, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Chronic Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Pacira MedInfo
• Organization: Pacira Bioscience, Inc.

MedInfo@Pacira.com

1-855-793-9729

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2012
• First Posted: October 11, 2012
• Study Start: September 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: July 1, 2013
• Last Updated: January 24, 2024
• Results First Posted: September 29, 2023

Record last verified: 2024-01

Locations

US (2)