Pain ManagementNCT06650631
The Effectiveness of Heat Treatment on Knee Pain in Patients With Osteoarthritis - an International, Multicenter Clinical Investigation
A study testing Knee Heatwraps in people with Pain Management and Osteoarthritis, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 69 years
- Conditions the study is for
- Pain Management, Osteoarthritis
- What is being tested?
- Knee Heatwraps
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- 21 Oct 2024to 29 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Ars Medica Clinic
Gravesano, Switzerland
Marco Marano, +41 916116480, mmarano@arsmedica.ch
Marco Marano
About this study
Official title: The Effectiveness of Heat Treatment on Knee Pain in Patients With Osteoarthritis - an International, Multicenter Clinical Investigation. Prospective, Open-label, One-arm, Post-market, Effectiveness Clinical Investigation
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).
- Conditions
- Pain Management, Osteoarthritis
- Being tested
- Knee Heatwraps
- Keywords
- Pain, Osteoarthritis, ThermaCare®, Medical Device
- Medical subject headings
- Agnosia, Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee HeatwrapsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Group: Patients with moderate knee osteoarthritis | Experimental | 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) Receives: Device: Knee Heatwraps |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At home from Day 1 to Day 4.
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: From day 0 to day 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start21 Oct 2024
- Primary completion29 Aug 2025 (estimated)
- Study completion29 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cross Research S.A.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650631
- Sponsor's protocol ID
- 161(B)MD22324
- Status last verified
- Oct 2024
- First submitted
- 18 Oct 2024
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Heat Treatment on Knee Pain in Patients With Osteoarthritis - an International, Multicenter Clinical Investigation. Prospective, Open-label, One-arm, Post-market, Effectiveness Clinical Investigation
- ClinicalTrials.gov ID
- NCT06650631
- Acronym / sponsor ID
- 161(B)MD22324
- Conditions
- Pain Management, Osteoarthritis
- Keywords
- Pain, Osteoarthritis, ThermaCare®, Medical Device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.AIndustry (pharma, biotech, devices)
- Collaborators
- Cross Research S.A.
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 29 Aug 2025 (estimated)
- Study completion
- 29 Aug 2025 (estimated)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group: Patients with moderate knee osteoarthritis | Experimental | Device: Knee HeatwrapsPatient 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) |
Who may qualify
- Ages
- 19 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
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 |
|---|---|---|
| Knee HeatwrapsTo 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. | Device | Group: Patients with moderate knee osteoarthritis |
Primary outcome
Pain intensity
Time frame: At home from Day 1 to Day 4.
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.
5 secondary outcomes
Sensorial perceptions evaluation
Time frame: At 15, 30, 45 min, 1 and 4 h post-application on Day 1
Pain intensity measured (%)
Time frame: At 8 and 16 h post-application; From Day 1 to Day 7
Functional levels and joint health measured (%)
Time frame: At 8 day (final visit)
Health status evaluation
Time frame: At final visit (Day 8).
Safety evaluation
Time frame: From day 0 to day 8.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knee Heatwraps in people with Pain Management and Osteoarthritis, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 1 site in Switzerland.
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 12 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: status not confirmed, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rosita Molinario (+39 3473243756, rosita.molinario@angelinipharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: At home from Day 1 to Day 4.). 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 8 Sep 2025.