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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  
Name  Address 
NIL   NIL  
 
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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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.
 
 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included ctri.nic.in).

  6. 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.

  7. 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.

 
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