Rupture of ligaments at ankle and foot level
Conditions
Interventions
The randomization sequence for the experimental and control groups, with a 1:1 allocation ratio, will be generated by computation by one of the researchers who will not be involved in recruiting and a
E02.258
Sponsors
Universidade Federal dos Vales do Jequitinhonha e Mucuri
Hospital Nossa Senhora da Saúde
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: People of both sexes aged between 18-60 years old; clinical diagnosis of grade I or II ankle sprains, indicating an incomplete ligament rupture; time of up to 72 hours from the episode of the injury to the day of the medical appointment; bone fractures excluded by radiography or by the Ottawa ankle rules
Exclusion criteria
Exclusion criteria: Grade III (severe) ankle sprain, indicating complete ligament injury, determined by a clear positive test of the anterior drawer and / or inversion stress test, accompanied by severe swelling, hemorrhage, high level of pain on palpation, in addition to total loss of the ability to support weight on the foot and of the dorsiflexion range of motion; open injuries that contraindicate the application of ice; having applied some form of cryotherapy more than once since the moment of the injury until the allocation process; apply some form of cryotherapy after being assigned to the control group; have any conditions that contraindicate the application of ice (e.g. Raynaud's syndrome), or any other intervention prescribed in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find an increase in the level of function in the short (7 to 14 days after allocation) and long term (12 weeks after allocation) follow-ups, assessed by the patient self-reported questionnaire Lower Extremity Functional Scale (0-80 points), based on the observation of a minimum clinically important difference of 9 points in post-intervention measurements between experimental and control groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to find a decrease of the pain intensity levels in the immediate (24h after allocation), short (7 to 14 days after allocation) and long term (12 weeks after allocation) follow-ups, assessed by the patient self-reported scale 0-10 Numerical Rating Scale (0 = no pain; 10 = worse pain), based on the observation of a minimum clinically important difference of 1.3 points in post-intervention measurements between experimental and control groups.;It is expected to find a decrease in ankle and foot swelling levels at short (7 to 14 days after allocation) and long term (12 weeks after allocation) follow-ups, assessed by the Figure of eight Method (Ankle-Foot perimetry), based on the observation of a minimal clinically important difference of 0. 93cm in the post-intervention measures between the experimental and control groups.;It is expected to find an increase of the ankle dorsiflexion range of motion levels in the short (7 to 14 days after allocation) and long term (12 weeks after allocation) follow-ups, assessed by two measurements of active ankle goniometry with the patient in the prone position (knee extension and with 90° of knee flexion to reduce the influence of the gastrocnemius). The ankle will be positioned in a position of 0° of movement in the sagittal plane, placing the goniometer axis over the calcaneus, with the fixed arm aligned with the calcaneal tendon and the mobile arm aligned with the second metatarsal. A digital goniometer will be used as measurement tool. The increase will be based on the observation of a minimum clinically important difference of 6 degrees in post-intervention measurements between experimental and control groups. | — |
Countries
Brazil
Contacts
Public ContactJúlio Miranda
Universidade Federal dos Vales do Jequitinhonha e Mucuri
Outcome results
None listed