Investigation on correlation between use of foot arc support and, Foot Pain and Tenderness, ankle strain and sprain in the population of soldiers in Shahid Hasheminejad garrisongarrison
Objectives: Investigation of relation between use of foot arc support and ّFoot Pain and Tenderness, Sprain and strain in soldiers of Shahid Hasheminejad Garisson (2) Design: Randomized, Not blinded ,Single centered (3)Setting and conduct: Soldiers entering the Garisson who meet the inclusion criteria are asked to complete a questionare regarding their demographic info, they are asked about past history of trauma or any intermittent or persistent pain in their lower limb. Then they are examined regarding flat foot, cavus, halux valgus and tenderness in any part of their lower limb below the knees. Then the soldiers are divided to a case and a control group according to Table of Random Numbers. Soldiers in the case group are given a Foot Arc Support to wear inside their martial boots and nothing is given to the control group. The two groups are followed regarding pain and tenderness in defferent parts of the lower limb and ankle sprain and strain and their severity according to VAS pain scale. (4)Participants including major eligibility criteria: Study population: Soldiers entering Hasheminejad Garrison in Neyshabur in April 21st Inclusion criteria: Foot arc must not be less than 1.5 cm No history of lower limb fracture Exclusion criteria: Soldiers who does not use foot arc support for any reason Population size: 580 Alpha: 0.05 Beta=0.2 P1=0.3 P2=0.2 (5)Intervention: Foot arc supports which are made of polyurethane are allocated to soldiers in the case group according to their foot size and nothing will be given to the other group.They will be followed for sprain and strain and different foot parts pain and tenderness occurrence during the 2-months period of their military service. Intervention period: April 21st 2014 to June 21st 2014 (7)Main outcome(Measures and Variables) : Strain, Sprain, Pain and tenderness in different foot parts, Pain severity according to VAS, Occurrence of swelling and echymosis
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014030916914N1
Registration date:2014-08-15, 1393/05/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-08-15, 1393/05/24
Registrant information
Name
Saman Nazemian
Name of organization / entity
Mashhad University of Medical Sciences, Faculty of Medicine
Country
Iran (Islamic Republic of)
Phone
+98 51 1764 7307
Email address
nazemians861@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research dean of Baqiatallah University of Medical Sciences, Baqiatallah Hospital, Trauma Research Center
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2014-06-21, 1393/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation on correlation between use of foot arc support and, Foot Pain and Tenderness, ankle strain and sprain in the population of soldiers in Shahid Hasheminejad garrisongarrison
Public title
Effect of Foot Arc Support in prevention of Foot Pain and Tenderness,ankle strain and sprain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The arc of the foot must not be less than normal ( the arc height should be at least about 1.5 cm);
The difference between the actual size of the the lowers limbs must not be more than 1 cm;
No history of fracture in the lower limbs must be present;
Must not be a professional athlete in football, volleyball, basketball or judo, taekwondo or other martial sports;
Body Mass Index ( BMI ) must not be less than 20;
Must not be exempted from marching by physician's order;
Exclusion criteria
If for any reason the soldier does not use the support or it goes wrecked;
If the soldier is discharged from the military service for any reason;
Age
From 18 years old to 35 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
580
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics in Research Committee, Baqiatallah University of Medical Sciences
Street address
Baqiatallah University, Sheikh bahaee St.
City
Tehran
Postal code
Approval date
2013-10-27, 1392/08/05
Ethics committee reference number
S340/3/6434 number 70- #33
Health conditions studied
1
Description of health condition studied
Stress Fracture
ICD-10 code
M84.3
ICD-10 code description
Stress fracture, not elsewhere classified Stress fracture NOS
stress fracture symptoms are introduced to the soldiers and when they feel pain in their foot they will come to the clinic and an X-ray of the foot will be ordered, if there was a fracture, the diagnosis is definite
2
Description
Ankle strain and sprain
Timepoint
During the 2 months period of military service
Method of measurement
Ankle sprain and strain symptoms are introduced to the soldiers, if it happens they come to the clinic and they will be examined for swelling or echymosis in the following days.
Secondary outcomes
1
Description
Tenderness in different parts of the foot
Timepoint
At the beginning and the end of the 2 months period of military service
Method of measurement
By touching firmly on tibia shin, ankle, calcaneum and metatarses the physician asks about feeling pain.
2
Description
Pain in different parts of the foot
Timepoint
At the beginning and the end of the 2 months period of military service
Method of measurement
Without touching on tibia shin, ankle, calcaneum and metatarses the physician asks about feeling pain and measuring pain severity according to VAS method by showing its pictures to the soldiers.
Intervention groups
1
Description
Soldiers who meet the inclusion criteria are divided into two groups according to random numbers table, foot arc support which is made of polyurethane is allocated to one group and nothing will be given to the other group. Foot arc support is believed to help to deliver the force along a bigger area of the foot sole and therefore reduce the pressure.The soldiers will be followed for stress fracture, sprain and strain and different foot parts pain and tenderness occurrence.
Category
Prevention
2
Description
An ordinary martial boot will be given to the control group.They will experience same martial exercises as the intervention group. They will also be followed for occurrence of different foot part pain and tenderness and ankle strain and sprain during the 2-months period of their military service.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Hasheminejad Garrison, Baqrud
Full name of responsible person
Dr Majdi
Street address
10km from Neyshabur, on Neyshabur Broad
City
Neyshabur
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Research in Baqiatallah Medical University, Trauma Research Center