| CTRI Number |
CTRI/2025/07/090125 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Measurement of Postural Changes during external load carriage in Persons with Low Back Pain |
|
Scientific Title of Study
|
Impact of External Load on Spinal Kinematics in Individuals with Chronic Low Back Pain with Lumbar Disc Degeneration: A Cross-Sectional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Apurba Barman |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Room no 5, Physical Medicine & Rehabilitation (PMR) OPD Block, Department Physical Medicine & Rehabilitation (PMR), All India Institute of Medical Sciences, Bhubaneswar Room no 5, Physical Medicine & Rehabilitation (PMR) OPD Block, Department Physical Medicine & Rehabilitation (PMR), All India Institute of Medical Sciences, Bhubaneswar Khordha ORISSA 751019 India |
| Phone |
9438884211 |
| Fax |
|
| Email |
apurvaa23@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Apurba Barman |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Room no 5, Physical Medicine & Rehabilitation (PMR) OPD Block, Department Physical Medicine & Rehabilitation (PMR), All India Institute of Medical Sciences, Bhubaneswar Room no 5, Physical Medicine & Rehabilitation (PMR) OPD Block, Department Physical Medicine & Rehabilitation (PMR), All India Institute of Medical Sciences, Bhubaneswar Khordha ORISSA 751019 India |
| Phone |
9438884211 |
| Fax |
|
| Email |
apurvaa23@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Apurba Barman |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Room no 5, Physical Medicine & Rehabilitation (PMR) OPD Block, Department Physical Medicine & Rehabilitation (PMR), All India Institute of Medical Sciences, Bhubaneswar Room no 5, Physical Medicine & Rehabilitation (PMR) OPD Block, Department Physical Medicine & Rehabilitation (PMR), All India Institute of Medical Sciences, Bhubaneswar Khordha ORISSA 751019 India |
| Phone |
9438884211 |
| Fax |
|
| Email |
apurvaa23@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences (AIIMS), Bhubaneswar, Sijua, PO Dumuduma, Dist Khurda, Odisha, PIN 751019 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences AIIMS Bhubaneswar |
| Address |
All India Institute of Medical Sciences (AIIMS), Bhubaneswar, Sijua, PO: Dumuduma, Dist: Khurda, PIN: 751019 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Apurba Barman |
All India Institute of Medical Sciences (AIIMS), Bhubaneswar |
Department of Physical Medicine & Rehabilitation (PMR), All India Institute of Medical Sciences (AIIMS), Bhubaneswar PO Dumuduma Khordha ORISSA |
9438884211
apurvaa23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, All India Institute of Medical Sciences, Bhubaneswar |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M478||Other spondylosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Participants with age 65 and above |
Each participant will undergo static posture and spinal alignment assessment under four (P0, P1, P2, P3) different load conditions, using the DIERS Formetric 4D motion analysis system.
The following positions will be tested:
•[P0] No Load: Standing without holding any weight. •[P1] Unilateral Load: Standing while holding a 10 kg weight in the right hand (arm extended).
•[P2] Bilateral Load (Arms Down): Standing while holding 5 kg in each hand (total 10 kg), with arms hanging straight at the sides.
•[P3] Bilateral Load (Front Carry): Standing while holding a 10 kg weight (5 kg in each hand) with elbows flexed, positioned at chest level in front of the body.
All assessments will be performed barefoot while standing on a Static treadmill. Participants will be positioned 2 meters away from the Formetric 4D projection and camera unit, as per the manufacturers protocol.
During each trial, participants will be asked to stand still in the designated posture for 2 minutes. For each position ([P0] through [P3]), five trials will be conducted to ensure data reliability. The average values from these five trials will be used for analysis. A minimum rest period of 5 minutes (or longer, based on participant need) will be provided between trials and test conditions to avoid fatigue. The total duration of the test will be around 45 minutes to 60 minutes. |
| Intervention |
Participants with age less than 65 years |
Each participant will undergo static posture and spinal alignment assessment under four (P0, P1, P2, P3) different load conditions, using the DIERS Formetric 4D motion analysis system.
The following positions will be tested:
•[P0] No Load: Standing without holding any weight.
•[P1] Unilateral Load: Standing while holding a 10 kg weight in the right hand (arm extended).
•[P2] Bilateral Load (Arms Down): Standing while holding 5 kg in each hand (total 10 kg), with arms hanging straight at the sides.
•[P3] Bilateral Load (Front Carry): Standing while holding a 10 kg weight (5 kg in each hand) with elbows flexed, positioned at chest level in front of the body.
All assessments will be performed barefoot while standing on a Static treadmill. Participants will be positioned 2 meters away from the Formetric 4D projection and camera unit, as per the manufacturers protocol.
During each trial, participants will be asked to stand still in the designated posture for 2 minutes.
For each position ([P0] through [P3]), five trials will be conducted to ensure data reliability. The average values from these five trials will be used for analysis.
A minimum rest period of 5 minutes (or longer, based on participant need) will be provided between trials and test conditions to avoid fatigue. The total duration of the test will be around 45 minutes to 60 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Persons with a history of chronic low back pain (CLBP) persisting for at least 3 months.
2. Reported pain intensity greater than 3 cm on the Visual Analog Scale (VAS) (0–10 cm).
3. Have undergone an MRI of the lumbosacral spine or the whole spine within the past three years.
4. Evidence of lumbar disc degeneration at one or more intervertebral levels, classified as Modified Pfirrmann Grade VI, VII, or VIII.
5. Demonstrate mild or no cognitive impairment, as indicated by a Mini-Mental State Examination (MMSE) score greater than 21. |
|
| ExclusionCriteria |
| Details |
1. History of spinal, hip, or knee surgery within the last 12 months.
2. Absence of relevant spinal imaging data (MRI).
3. Presence of any neurological deficits.
4. Inability to perform basic physical or household activities.
5. Body Mass Index (BMI) more than 35.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Lumbar Lordosis And Thoracic Kyphosis Angle |
Single session: All outcome measures will be recorded during one study visit under four loading conditions (P0, P1, P2, P3) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
A. Sagittal Plane Parameters:
1. Trunk inclination (°)
2. Pelvic tilt (°)
B. Sagittal Imbalance (mm)
1. Fleche Cervicale (mm)
2. Fleche Lombaire (mm)
C. Coronal Plane Parameters:
1. Coronal Trunk Imbalance (mm)
2. Coronal Trunk Imbalance (°)
3. Pelvic Obliquity (°)
D. Transverse Plane Parameters:
1. Pelvic Torsion (°)
2. Vertebral Rotation (L1–L5) (°)
E. Pain Intensity:
1. Visual Analog Scale (VAS, 0–10 cm) |
Single session: All outcome measures will be recorded during one study visit under four loading conditions (P0, P1, P2, P3) |
|
|
Target Sample Size
|
Total Sample Size="31" Sample Size from India="31"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/08/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included ctri.nic.in).
- For how long will this data be available start date provided 01-08-2026 and end date provided 01-12-2036?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Low back pain (LBP) remains a leading cause of
disability globally, with a particularly high burden in low- and middle-income
countries. It is evident from the literature that up to 84% of the population
experience LBP during their lifetime, and among them nearly 23% develop chronic
low back pain (CLBP). CLBP is associated with significant functional
limitations and a substantial impact on quality of life.
Postural adaptations are commonly observed in
individuals with CLBP. Conversely, poor posture itself can contribute to the
development or persistence of LBP by adversely affecting spinal alignment and
flexibility. Structural alterations in spinal curvatures—particularly in the
lumbar and thoracic regions—have been shown to increase mechanical stress on vertebrae
and lumbopelvic structures. These changes may lead to intersegmental
instability and further degeneration of the spine, particularly at the
intervertebral disc level.
Spinal alignment (SA) can be further influenced by
external factors such as lifting or holding weight. While the spine employs
various compensatory mechanisms to maintain sagittal balance in static
conditions, these mechanisms may be challenged or become insufficient during
load-bearing activities. The response of the spine to such mechanical loading
is particularly relevant in individuals with CLBP, where age-related spinal
degeneration and reduced paraspinal muscle strength may impair compensation and
exacerbate kinematic disturbances.
Although some studies have explored the effects of
external load in healthy or military populations under static conditions, there
is limited research investigating its impact in individuals with CLBP.
Moreover, little is known about how these responses vary across age groups,
particularly in older adults who may experience more pronounced degenerative
changes.
Recent advanced technologies such as the DIERS formetric 4D system (DIERS
Medical Systems, Chicago, IL) allow for accurate, non-invasive assessment of
spinal posture and movement. This radiation-free system uses surface topography
to capture spinal curvature, vertebral rotation, and pelvic alignment over a
six-second scan, providing reliable data for evaluating static postural
alignment under different loading conditions.
Given the lack of evidence in biomechanical changes
in the spine in individuals with CLBP, this study aims to:
- Evaluate the effects of external load on
spinal alignment parameters (including spinal curvature angles, trunk
inclination, pelvic tilt, and lumbar vertebral rotation), - Compare these parameters between younger and
older adults with CLBP - Investigate the influence of age, disc degeneration,
physical activity, and functional disability on spinal kinematic responses to
load. |