Aim of this study is Comparison of surgical or non-surgical treatment outcomes in patients with thoracolumbar fracture with score 4 of TLICS. This study is clinical trial and double blind. We will interne patient with trauma and thoracolumbar fracture with score 4 of TLICS in this study.We will divide 50 patient randomly in two group (intervention group: we treat 25 patient with surgery) (control group: We treat 25 patient with not surgery treatment). Not surgery treatment is including: horizontal bed rest for 5 days, standard physiotherapy, appliance bras and not severe physical body. We will follow all patients for one year after treatment. Outcome and follow is including: duration of bedridden, duration of absent for work, return for work before trauma, visual analog scale (before intervention and every 3 months to one years), radiography (before intervention and every 3 months to one years)
Inclusion criteria: 18-60 years; fracture in T1 to L4; interval of trauma to bedridden less than 10 days
Exclusion criteria: pregnancy; pathological and osteoporosis fracture; history of surgery in spine; ASA IV
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017010920258N25
Registration date:2017-01-18, 1395/10/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-18, 1395/10/29
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Challore of Research , Arak University of medical Siences
Expected recruitment start date
2016-04-26, 1395/02/07
Expected recruitment end date
2017-04-27, 1396/02/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of surgical or non-surgical treatment outcomes in patients with thoracolumbar fracture with score 4 of TLICS
Public title
Comparison of surgical or non-surgical treatment outcomes in patients with thoracolumbar fracture with score 4 of TLICS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 18-60 years; fracture in T1 to L4; interval of trauma to bedridden less than 10 days
Exclusion criteria: pregnancy; pathological and osteoporosis fracture; history of surgery in spine; ASA IV
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomize by tablث of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
Street address
Dr Mohammad Rafiei, Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Postal code
38149578558
Approval date
2016-04-25, 1395/02/06
Ethics committee reference number
IR.ARAKMU.REC.1395.39
Health conditions studied
1
Description of health condition studied
Thoracic fracture
ICD-10 code
S22.0
ICD-10 code description
Fracture of thoracic vertebra
2
Description of health condition studied
Lumbar fracture
ICD-10 code
S32.0
ICD-10 code description
Fracture of lumbar vertebra
Primary outcomes
1
Description
duration of bedridden in hospital
Timepoint
after surgery
Method of measurement
day
2
Description
duration of absent for work
Timepoint
before and after surgery
Method of measurement
day
3
Description
Pain
Timepoint
before intervention and every 3 months to one years
Method of measurement
Visual Analogue Scale
4
Description
Local sagittal angles
Timepoint
before intervention and every 3 months to one years
Method of measurement
radiography
5
Description
Regional sagittal angles
Timepoint
before intervention and every 3 months to one years
Method of measurement
radiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 25 patients are undergoing surgery.
Category
Treatment - Surgery
2
Description
Control group: We treat 25 patient with not surgery treatment.Not surgery treatment is including: horizontal bed rest for 5 days, standard physiotherapy, appliance bras and not severe physical body
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Alireza Mohammadi
Street address
Valiasr hospital, Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences