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CTRI Number  CTRI/2013/02/003400 [Registered on: 15/02/2013] Trial Registered Prospectively
Last Modified On: 15/02/2013
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Assessment of postural changes in low back pain patients using a novel technique 
Scientific Title of Study   SPINAL AND PELVIC POSTURAL ASSESSMENT IN SUBJECTS WITH AND WITHOUT MECHANICAL LOW BACK PAIN USING SURFACE TOPOGRAPHY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Not Applicable  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ARUN MATHEW CYRIAC 
Designation  MASTER OF PHYSIOTHERAPY IN MUSCULOSKELETAL AND SPORTS 
Affiliation   
Address  DEPARTMENT OF PHYSIOTHERAPY, FATHER MULLER MEDICAL COLLEGE, FATHER MULLER ROAD, KANKANADY, MANGALORE-575002

Dakshina Kannada
KARNATAKA
575002
India 
Phone  09886638763  
Fax    
Email  arun.mathewpt@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  NARASIMMAN S 
Designation  Head of the Dept 
Affiliation   
Address  DEPARTMENT OF PHYSIOTHERAPY, FATHER MULLER MEDICAL COLLEGE, FATHER MULLER ROAD, KANKANADY, MANGALORE-575002

Dakshina Kannada
KARNATAKA
575002
India 
Phone  09480265509  
Fax    
Email  naraswamin2001@gmail.com  
 
Details of Contact Person
Public Query
 
Name  ARUN MATHEW CYRIAC 
Designation  MASTER OF PHYSIOTHERAPY IN MUSCULOSKELETAL AND SPORTS 
Affiliation   
Address  DEPARTMENT OF PHYSIOTHERAPY FATHER MULLER MEDICAL COLLEGE MANGALORE FATHER MULLER ROAD, KANKANADY, MANGALORE-575002

Dakshina Kannada
KARNATAKA
575002
India 
Phone  09886638763  
Fax    
Email  arun.mathewpt@yahoo.co.in  
 
Source of Monetary or Material Support  
FATHER MULLER CHARITABLE INSTITUTION, MANGALORE. 
 
Primary Sponsor  
Name  Father Muller Charitable Institution Hospital 
Address  Father Muller Road, Kankanady, MANGALORE, Karanataka-575002 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
FATHER MULLER CHARITABLE HOSPITAL  FATHER MULLER ROAD, KANKANADY, MANGALORE-575002 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Narasimman S  Dept of Physiotherapy OPD  FATHER MULLER MEDIACL COLLEGE HOSPITAL, FATHER MULLER ROAD, KANKANADY, MANGALORE-575002
Dakshina Kannada
KARNATAKA 
09480265509

naraswamin2001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
FATHER MULLER INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients referred to physiotherapy, with complaints of low back pain ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Degenerative disc disease with/ without herniation
2. Mechanical Back Pain ( Facet Joint Syndrome, Muscular injury, ligamentous injury)
3. Osteoarthritis of Spine
 
 
ExclusionCriteria 
Details  1. Spondylolisthesis
2. Spondylolysis
3. Scoliotic deformity
4. Pregnancy
5. Metabolic Diseases
6. Neoplasm
7. Congenital Deformities
8. Spinal Injuries
9. Recent general surgery(past 12 months)

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• Lordotic Angle
• Surface Rotation
 
Surface Topography By Diers Formetric 4D Average Machine
 
 
Secondary Outcome  
Outcome  TimePoints 
. Pelvic Tilt
• Pelvic Torsion
• Pelvic Inclination
• Kyphotic Angle  
Formetric 4D Average (Diers International GmbH, Sclanenbad, Germany) 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/03/2013 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Low back pain (LBP) is a common musculoskeletal problem that not only causes physical morbidity as well as socio-economic loss in the community. The lifetime incidence rates of this clinical condition have been estimated to be between 50-90%.1

           Investigators have classified the differential diagnosis of low back pain mainly into mechanical causes (no primary inflammatory or neoplastic cause – 97%), visceral causes (no primary involvement of the spine – 2%), and non mechanical causes (Neoplasia, Infection, inflammatory arthritis etc – 1%). Many uncomplicated low back pain cases are assumed to result as a result of muscle sprains and strains, ligamentous injuries, and spinal degenerative changes. Disc herniation with nerve root compression or irritation has been proposed to be the most common cause of neurologic abnormalities.2

 

The lumbo-sacral region, being the most important region in the vertebral column in terms of mobility and weight bearing, mechanical disorders of this region cause LBP. Various studies have examined the relationship between changes in the angles of the lumbar spine and LBP and have shown significant differences in saggital profile of the lumbar spine between asymptomatic subjects and patients with LBP.3

 

Loss or flattening of the normal lumbar lordosis is an important clinical sign of back problems as the patient is thought to keep the spine in a upright and straight position, to reduce pain. But some studies suggests that, patients with chronic LBP have either no difference or increased lumbar lordosis with respect to controls, which shows  that, variations of the lumbar spine may / may not relate to reported symptoms.4 These lumbar anatomical changes would lead to an increased anterior tilt of the pelvis and an exaggerated lumbar lordosis during relaxed standing.5

 

                  There still exists a controversy in the scientific literature regarding lumbo-sacral posture and low back pain. Thoracic kyphosis, lumbar lordosis, pelvic tilt, and abdominal strength are the most investigated parameters, with respect to low back pain.6

 

Conventionally, LBP assessment is based on clinical diagnosis and is best established with an abnormality, evident in a radiograph. For the detection of pathological changes of the spine shape, the gold standard remains to be, the clinical examination along with radiological techniques such as X-ray, CT and MRI until today. The radiation from these diagnostic procedures leads to a very critical deployment for follow-up examinations, particularly in young patients. For this reason, simple, but inaccurate and poorly reliable methods were developed for follow-up examinations of the spine like the kyphometer or the curve ruler. More advanced methods like VICON Video System or the ultrasound-based Zebris- System were developed eventually, which were based upon the placement of marker on the skin over bony landmarks of the patients. These techniques were then found, to lead to measuring errors due to a possible shift of the skin over the underlying bony structures.7

 

This study uses surface topography to compare the spinal and pelvic patterns in patients with LBP with that of normal subjects. It is a validated, reliable, precise, radiation-free and inexpensive method for detecting the spinal posture, developed in early 1980’s, based on the technology of raster-stereography (RSG). This might help resolve some of the controversy and be useful in identifying patterns that may be associated with LBP. To our knowledge, no studies have been reported to be done, on spinal and pelvic postural deviations in LBP using surface topography. The paucity of scientific information available to support the spinal and pelvic postural deviations in LBP may be tackled with this study. This may aid in the diagnosis and treatment of LBP patients and also affect the planning of a proper exercise program for the back / abdominal muscle.

HYPOTHESIS:Subjects with mechanical LBP have spinal and pelvic postural deviations when compared with the normal subjects.  
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