The effectiveness of thermal treatment on knee pain in patients with osteoarthritis - an international multicenter clinical investigation

Descrizione riassuntiva dello studio

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)

Intervento studiato

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)

Malattie studiate

Knee osteoarthritis

(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)

Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)

Commissione d'etica Ticino

(BASEC)

Data di approvazione del comitato etico

23.09.2024

(BASEC)

Risultati dello studio