An interventional study of Knee Heatwraps in Pain Management and Osteoarthritis, sponsored by Aziende Chimiche Riunite Angelini Francesco S.p.A. Recruiting at 1 site in Switzerland. Open to participants aged 19 Years to 69 Years. Per ClinicalTrials.gov, last updated 2025-09-08.
Sponsored by Aziende Chimiche Riunite Angelini Francesco S.p.A · Not applicable, Interventional, and Treatment
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).
2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.
This study's planned enrollment of 80 is close to the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Aziende Chimiche Riunite Angelini Francesco S.p.A is the lead sponsor of 40 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient without acute flares or inflammation 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)
Device: Knee Heatwraps
To treat the painful knee joint in patients with osteoarthritis without acute flares or inflammation. The investigational device will be used in accordance with the Instructions for Use.
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.
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.
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