Acute anterior cruciate ligament disruption Musculoskeletal Diseases Acute anterior cruciate ligament disruption
Conditions
Interventions
Participants are randomly allocated to one of three groups.
Experimental intervention group: Participants use the "cool down Fix Aid" cooling product, which consists of a standardized
Sponsors
Cool Down AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Acute anterior cruciate ligament disruption (8 weeks post-traumatic) 2. Aged between 18 and 60 years 3. With and without concomitant ligament injuries
Exclusion criteria
Exclusion criteria: 1. Chronic leg pain 2. Hypersensitivity, cold tolerance, peripheral neuropathy, diabetes mellitus 3. Eczema or rashes 4. Allergy to menthol and/or ethanol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cross-sectional measurement of vastus medialis measured in millimeters on day 1, 30, 60 and 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Skin temperature is measured in degree Celsius by using an iButton on day 1 tand 3 2. Knee swelling and Range of Motion (ROM) are measured in circumference in centimeters and degrees by using a tape measure and a handheld goniometer on day 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78 and 85 3. Consumption of analgesic medication is measured using an questionnaire on day 7 and 30 4. Pain perception and comfort feeling is measured using an questionnaire with Numerical Ratingscale (NRS) and Thermal comfort scale on day 1 and 30 5. Muscle strength is measured in maximum torque value of knee extension and flexion, which is expressed in newton metre by using an isokinetic dynamometer (Biodex System) on baseline and day 90 | — |
Countries
Switzerland
Outcome results
None listed