The Effectiveness of Heat Treatment on Knee Pain in Patients With Osteoarthritis - an International, Multicenter Clinical Investigation

Aziende Chimiche Riunite Angelini Francesco S.p.A80 enrolled

Overview

This post-market clinical follow-up, open-label, multicenter clinical investigation is designed to investigate the effectiveness, safety and tolerability of ThermaCare® Knee Heatwraps in the painful knee joint due to osteoarthritis. Approximately 80 patients, 19-69 years old inclusive, with moderate knee osteoarthritis (without acute flares or inflammation) will be enrolled. The overall duration of the investigation is expected to be 11 days, including screening days. The maximum treatment duration for each patient is 7 days (8h/d).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain Management Osteoarthritis

Interventions

Eligibility

Sex: ALLMin age: 19 YearsMax age: 69 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Signed written informed consent before inclusion in the investigation. * Any gender, any ethnic origin, 19-69 years old inclusive. * Body Mass Index 18.5-40 kg/m2 inclusive. * Full comprehension: ability to comprehend the full nature and purpose of the clinical investigation. * Patient with diagnosis of mono or bilateral moderate knee osteoarthritis with knee pain intensity \> 40 mm on a 0-100 mm VAS, able to independently ambulate without walking aid. * Availability of a radiography of the selected knee not older than 6 months. * Patient is either not of childbearing potential or must agree not to start a pregnancy from the signature of the informed consent up to the final visit Exclusion Criteria: * Clinically significant abnormal physical findings which could interfere with the objectives of the investigation * History of anaphylaxis to drugs or allergic reactions in general, which could affect the outcome of the clinical investigation. * Significant history of diseases that may interfere with the aim of the clinical investigation. * History of (in the last 6 months) or ongoing intra-articular injection involving the selected knee. History of ongoing physical therapy involving the selected knee. * Presence of flares, inflammation, effusion and swelling at the selected knee. * Any skin injury, wound, irritation, rash, bump, sore and/or discoloration at the application area. * Surgery at the selected knee in the 12 months preceding the clinical investigation. * Any medication that could interfere with the investigation procedures or investigation outcome. * Use of other hot or cold therapies for the selected knee. * Positive pregnancy test at screening; pregnant or breastfeeding women * History of (within the past 12 months) or current drugs or alcohol abuse * Individuals unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced because of a compromised position, expectation of benefits or fear of retaliatory response.

Outcomes

Primary Outcomes

Pain intensity

The primary endpoint of this clinical investigation is the change from baseline of pain intensity measured by Visual Analogue Scale (VAS) at Day 4, i.e., after 3 days of treatment. The VAS was chosen for the pain evaluation since it is a simple, quick and easy to use scale, suitable for different populations, such as adults and elderly individuals. Pain intensity will be measured using a 0-100 mm VAS.

Time frame: At home from Day 1 to Day 4.

Secondary Outcomes

Sensorial perceptions evaluation

Results of the sensorial perceptions evaluation collected by a questionnaire. Questionnaire replies will be self-recorded by the patients in their individual diaries.

Time frame: At 15, 30, 45 min, 1 and 4 h post-application on Day 1

Pain intensity measured (%)

Percent change and change from baseline of pain intensity measured by VAS. The Visual Analogue Scale was chosen for the pain evaluation since it is a simple, quick and easy to use scale, suitable for different populations, such as adults and elderly individuals.

Time frame: At 8 and 16 h post-application; From Day 1 to Day 7

Functional levels and joint health measured (%)

Percent change and change from baseline in functional levels and joint health measured by Knee Injury and Osteoarthritis Outcome (KOOS) questionnaire at final visit. The questionnaire is an established patient-reported outcome instrument commonly used in clinical research. It is utilized to measure the changes in patient's health status in a standardized way. The questionnaire was chosen since adequate to both older and younger patients, able to combine short and long-term outcomes in a meaningful way and self-administered to patients through a questionnaire. The format is user-friendly and it takes about 10 minutes to fill-in. The standard KOOS questionnaire foresees 5 dimensions: pain, symptoms, activity of daily living, sport and recreation, quality of life. The sport, recreation dimension will not be assessed in this clinical investigation because we expect the enrolment of many elderly patients, for whom this section would not be applicable. The pain is already evaluatedby VAS.

Time frame: At 8 day (final visit)

Health status evaluation

Results of the overall health status evaluation performed by the Investigator by the CGI-I scale (Clinical Globally Impression - Improvement). This scale was selected since it is a simple, brief and stand-alone method allowing the clinician to assessing treatment response and overall improvement or worsening of the health conditions in clinical study participants. Sensorial perceptions and subject's satisfaction will be evaluated using questionnaires specifically designed for this purpose for this clinical investigation. CGI-I scale including 7 levels of achieved improvement/worsening (final visit/ETV).

Time frame: At final visit (Day 8).

Safety evaluation

Adverse events (AEs), including serious adverse events/serious device effects and special situations. Device deficiencies that might have led to a serious adverse event and any new findings.

Time frame: From day 0 to day 8.