This study is designed to compare two treatment modalities of the ankle sprain. This is a single center, double-blind randomized trial. One hundred and twenty patients of 18 to 60 years with grade 1 and 2 ankle sprains are enrolled, who are visited at the emergency department within 48 hours after the injury. Patients who have fractures or other injuries, or those who cannot be followed are excluded from the study.
After the initial evaluation, patients are randomly divided into two groups. They pick up one of the envelopes in which two types of treatments are written. They are unaware of envelopes contents. Then, they enroll to the treatment groups of A (short leg cast) or B (short leg splint). Patients will be evaluated two and six weeks after the treatment regarding pain score, rate of swelling, and range of motion of the joint.
The researcher is also unaware of the type of therapy. Treatment is done by another emergency physician and researcher only evaluates the variables and outcomes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016071528941N1
Registration date:2017-01-30, 1395/11/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-30, 1395/11/11
Registrant information
Name
Homa Javan
Name of organization / entity
Mashhad University of Medical Sciencess
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 1538
Email address
javanh931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2016-07-31, 1395/05/10
Expected recruitment end date
2016-10-21, 1395/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of casting and splinting in the treatment of ligament injuries of ankle sprain
Public title
Difference between casting and splinting in the treatment of ankle sprain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients of 18 to 60 years old who are visited over the past 48 hours due to ankle sprain.
Exclusion criteria: Patients with fractures, multiple injuries, debilitating disease, grade 3 ligament injury or patients who are from another city or not consent to the study.
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Before the intervention, two and six weeks after the intervention
Method of measurement
Visual Analogue Scale
2
Description
Ability to walking
Timepoint
Before the intervention, two and six weeks after the intervention
Method of measurement
Questionnaire
3
Description
Range of motion of ankle joint
Timepoint
Before the intervention, two and six weeks after the intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Pain score
Timepoint
Before the intervention, two and six weeks after the intervention
Method of measurement
Visual Analogue Scale
2
Description
Ability to walking
Timepoint
Before the intervention, two and six weeks after the intervention
Method of measurement
Questionnaire
3
Description
Range of motion of ankle joint
Timepoint
Before the intervention, two and six weeks after the intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: In this group, full immobilization of ankle is done using the short leg cast. First, one layer of wibril is wrapped around the patient's leg (from the lower part of the knee to the metatarsophalangeal joint). Then, the plaster of paris (gipsoband) is soaked in water. Then, it is wrapped in several layers around the wibril and molded. The leg is protected until drying and hardening of the plaster.
Category
Treatment - Other
2
Description
Control Group: In this group, ankle is immobilized using short leg splint. A pre-prepared packs of splint is placed at the posterior part of the patient's foot (from the lower part of the knee to the metatarsophalangeal joint), after soaking in water. Then, it is rounded and closed with an elastic band.