| 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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients referred to physiotherapy, with complaints of low back pain , |
|
|
Intervention / Comparator Agent
|
|
|
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. |