The effectiveness of thermal treatment on knee pain in patients with osteoarthritis - an international multicenter clinical investigation
Zusammenfassung der Studie
This clinical investigation will be conducted at the Ars Medica Clinic and the Sport-Ars Medica Center located in Lugano, and aims primarily to evaluate the effectiveness of ThermaCare® self-heating knee wraps in reducing pain. This medical device will be used in this clinical investigation to treat approximately 80 patients suffering from osteoarthritis who do not have excessive pain or ongoing inflammation. The medical device under investigation will be used according to the instructions for use. Each patient will independently apply a heating wrap once a day for 7 consecutive days to the same knee. The heating wrap will be applied every afternoon at 3:00 PM ±1 h, from day 1 to day 7, and maintained in position for 8 h±15 min. The ThermaCare® heating wrap is already available on the market in several European countries, but is not yet available in Switzerland. This clinical investigation includes a preliminary outpatient visit, called screening, followed by a treatment phase during which patients must come to the clinical center by the morning or early afternoon of day 4, and must present themselves on day 8 for a final outpatient visit. During the clinical investigation, patients are expected to complete a daily diary to record information related to the use of the medical device, as well as any information related to side effects or other medications taken during the study. The diary will also include questionnaires for assessing pain and the feeling of benefit experienced by patients during treatment with ThermaCare®.
(BASEC)
Untersuchte Intervention
The maximum duration of the clinical investigation for each patient is 11 days. It includes a preliminary outpatient visit, called screening, followed by a treatment phase during which patients must come to the clinical center by the morning or early afternoon of day 4, and must present themselves on day 8 for a final outpatient visit.
The following procedures will be implemented.
During the preliminary screening visit, it will be verified that the patient's conditions meet the required inclusion/exclusion criteria. This visit includes an explanation of the objectives, procedures, and potential risks of the trial and the signing of informed consent. Demographic data and information regarding medical history, lifestyle, and any medications that the patient may have taken will be collected. The patient will undergo a physical examination and an assessment of the knee affected by the condition, including weight and height measurement. If female, a pregnancy test will be performed. Questionnaires will be administered to assess pain and to evaluate symptoms, the impact of the condition on daily life activities, and quality of life. If at this point the subject meets all inclusion/exclusion requirements, they will be eligible and can participate in the clinical investigation. The medical device to be applied from the following day and the diary that the patient must complete as per the instructions received from the physician will be provided.
In the following 3 days, the patient must apply the medical device once a day at 3:00 PM ±1 h. Only on day 1 must they complete the questionnaire present in the diary for sensory perceptions at 15, 30, 45 minutes, 1 and 4 hours after application. The medical device must be removed 8 h±15 min after application, and pain must be assessed by completing the questionnaire called VAS at 8 and 16 hours after application of the device. The diary must be completed.
On day 4, the patient must return to the center with the boxes containing the used and unused heating wraps, along with the completed diary. They will receive the diary again after it has been checked by the physician and the new boxes containing the medical device.
From the afternoon of the same day and in the following 3 consecutive days, the patient must apply the medical device once a day at 3:00 PM ±1 h. The medical device must be removed 8 h±15 min after application, and pain must be assessed by completing the questionnaire called VAS at 8 and 16 hours after application of the device. The diary must be completed.
On day 8, the patient must return to the center with the boxes containing the used and unused heating wraps, along with the completed diary, which will be checked by the physician.
The patient will be given the questionnaire to assess symptoms, the impact of the condition on daily life activities, and quality of life, the physician will evaluate the patient's health status, perform a general physical examination, and assess the knee affected by the condition.
During all visits, the physician will evaluate what the patient has entered in the diary and any adverse events that have occurred and/or concomitant therapies taken by the patient.
At the end of the final visit, patients will be able to leave the clinical center.
(BASEC)
Untersuchte Krankheit(en)
Knee osteoarthritis
(BASEC)
1) Signing of the written informed consent, to be obtained prior to participation in the study 2) Patients of any gender and ethnic origin, aged 19 to 69 years inclusive, who have been diagnosed with knee osteoarthritis 3) Ability to be collaborative with the investigator and to understand the nature and purpose of the clinical investigation, including potential risks and side effects (BASEC)
Ausschlusskriterien
1) medical visit, clinically significant anomalies and/or indications of an ongoing disease. 2) history of intra-articular injection in the last 6 months or physiotherapy in the previous month involving the affected knee 3) intake of other medications/treatments that may interfere with the clinical investigation. (BASEC)
Studienstandort
Lugano
(BASEC)
Sponsor
Angelini Pharma S.p.A., Viale Amelia, 70, 00181 Rome, Italy CROSS Research S.A., Via F.A. Giorgioli 14, CH-6864 Arzo
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Marco Marano, Investigatore Principale Coordinatore
+41.91.611.64.80
mmarano@clutterarsmedica.chClinica Ars Medica, Via Grumo 16, CH-6929 Gravesano
(BASEC)
Allgemeine Auskünfte
+39 3473243756;+41 916116480
rosita.molinario@angelinipharma.com; mmarano@clutterarsmedica.ch(ICTRP)
Allgemeine Auskünfte
+39 3473243756+41 916116480
rosita.molinario@angelinipharma.commmarano@clutterarsmedica.ch(ICTRP)
Wissenschaftliche Auskünfte
+39 3473243756;+41 916116480
rosita.molinario@angelinipharma.com; mmarano@clutterarsmedica.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Tessin
(BASEC)
Datum der Bewilligung durch die Ethikkommission
23.09.2024
(BASEC)
ICTRP Studien-ID
NCT06650631 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
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 (BASEC)
Wissenschaftlicher Titel
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 (ICTRP)
Öffentlicher Titel
The Effectiveness of Heat Treatment on Knee Pain in Patients With Osteoarthritis - an International, Multicenter Clinical Investigation (ICTRP)
Untersuchte Krankheit(en)
Pain ManagementOsteoarthritis (ICTRP)
Untersuchte Intervention
Device: Knee Heatwraps (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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. (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Pain intensity (ICTRP)
Sensorial perceptions evaluation;Pain intensity measured (%);Functional levels and joint health measured (%);Health status evaluation;Safety evaluation (ICTRP)
Registrierungsdatum
18.10.2024 (ICTRP)
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
Cross Research S.A. (ICTRP)
Weitere Kontakte
Rosita Molinario;Marco Marano, rosita.molinario@angelinipharma.com; mmarano@arsmedica.ch, +39 3473243756;+41 916116480 (ICTRP)
Sekundäre IDs
161(B)MD22324 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT06650631 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar