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

NCT06650631 | Recruiting

• 1 other identifier: 161(B)MD22324
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Pain; Osteoarthritis; ThermaCare®; Medical Device

Outcome Measures

Primary Outcomes (1)

• 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.

  At home from Day 1 to Day 4.

Secondary Outcomes (5)

• Sensorial perceptions evaluation

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

• Pain intensity measured (%)

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

• Functional levels and joint health measured (%)

  At 8 day (final visit)

• Health status evaluation

  At final visit (Day 8).

• Safety evaluation

  From day 0 to day 8.

Study Arms (1)

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)

Device: Knee Heatwraps

Interventions

Knee Heatwraps DEVICE

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.

Group: Patients with moderate knee osteoarthritis

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aziende Chimiche Riunite Angelini Francesco S.p.A: lead
• Cross Research S.A.: collaborator

Study Sites (1)

Ars Medica Clinic

Gravesano, Switzerland, Switzerland

RECRUITING

MeSH Terms

Conditions

Agnosia; Osteoarthritis; Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Rosita Molinario

CONTACT

+39 3473243756; rosita.molinario@angelinipharma.com

Enrica Salvatori

CONTACT

+39 3458063168; Enrica.salvatori@angelinipharma.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 21, 2024
• Study Start: October 21, 2024
• Primary Completion: August 29, 2025
• Study Completion: August 29, 2025
• Last Updated: September 8, 2025

Record last verified: 2024-10

Locations

CH (1)