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CTRI Number  CTRI/2025/11/097837 [Registered on: 21/11/2025] Trial Registered Prospectively
Last Modified On: 04/04/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Effect of external weight carriage on body posture in healthy persons and in patients with back pain 
Scientific Title of Study   Influence of External Load on Spinal Alignment in Individuals With and Without Chronic Low Back Pain: A Cross-Sectional Analysis 
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 of Physical Medicine & Rehabilitation, AIIMS, Bhubaneswar
Sijua, Patrapada, PO Dumuduma
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 of Physical Medicine & Rehabilitation, AIIMS, Bhubaneswar
Sijua, Patrapada, PO Dumuduma
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 of Physical Medicine & Rehabilitation, AIIMS, Bhubaneswar
Sijua, Patrapada, PO Dumuduma
Khordha
ORISSA
751019
India 
Phone  9438884211  
Fax    
Email  apurvaa23@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Bhubaneswar, Sijua, PO Dumuduma, Dist Khurda, Odisha PIN 751019 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences (AIIMS), Bhubaneswar 
Address  Bhubaneswar, Sijua, PO Dumuduma Dist Khurda, Odisha, PIN 751019 
Type of Sponsor  Other [Govt 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  Room No 1, Motion Analysis Lab, Department of Physical Medicine & Rehabilitation (PMR)
Khordha
ORISSA 
9438884211

apurvaa23@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Sciences, Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Without back pain 
Patients  (1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group II: Participants without chronic back pain (Healthy control)  all participants will undergo static posture and spinal alignment assessment under four 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 approximate duration of each persons motion analysis will be around 60-90 minutes. In accordance with DIERS Motion Lab protocol, no reflective markers will be used on the back or spine. The DIERS Formetric 4D system will assess surface topography and spinal parameters in a non-invasive, radiation-free manner. 
Intervention  Group-I Participants with chronic back pain  all participants will undergo static posture and spinal alignment assessment under four 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 approximate duration of each persons motion analysis will be around 60-90 minutes. In accordance with DIERS Motion Lab protocol, no reflective markers will be used on the back or spine. The DIERS Formetric 4D system will assess surface topography and spinal parameters in a non-invasive, radiation-free manner. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Adults aged 18 years or older 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. 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. Presence of any neurological deficits.
3. Inability to perform basic physical or household activities.
4. Body Mass Index 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 angle and thoracic kyphosis angle  Single session all outcome measures will be recorded during one study visit under four load (P0, P1, P2, P3) 
 
Secondary Outcome  
Outcome  TimePoints 
1.Sagittal Plane Parameters:
o Trunk inclination (°)
o Pelvic tilt (°)
o Sagittal Imbalance (mm)
o Fleche Cervicale (mm)
o Fleche Lombaire (mm)

2. Coronal Plane Parameters:
o Coronal Trunk Imbalance (mm)
o Coronal Trunk Imbalance (°)
o Pelvic Obliquity (°)

3. Transverse Plane Parameters:
o Pelvic Torsion (°)
o Vertebral Rotation (L1–L5) (°)

4. Pain Intensity:
o Visual Analog Scale (VAS, 0–10 cm)  
Single session : all outcome measures will be recorded during one study visit under four load (P0, P1, P2, P3) 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   01/12/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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 - Informed Consent Form
    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 - To achieve aims in the approved proposal.

  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 28-01-2028 and end date provided 28-01-2045?
    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) continues to be one of the leading causes of disability worldwide, imposing a significant burden on individuals and healthcare systems, especially in low- and middle-income countries. Epidemiological studies estimate that up to 84 percent of individuals will experience LBP at some point in their lives, with nearly 23 percent progressing to chronic low back pain (CLBP), defined as pain persisting for more than three months. CLBP is frequently associated with impaired mobility, reduced quality of life, and diminished functional capacity. Postural adaptations are commonly observed in individuals with CLBP, often as compensatory mechanisms to manage pain or mechanical instability. Conversely, poor posture and altered spinal mechanics may contribute to the onset and persistence of LBP by disrupting normal spinal alignment and flexibility. Structural changes in spinal curvature, particularly in the lumbar and thoracic regions, can increase biomechanical stress on vertebrae, intervertebral discs, and lumbopelvic structures, potentially leading to intersegmental instability and accelerated degeneration.

 

Spinal alignment is influenced not only by intrinsic factors, such as disc degeneration or muscle strength, but also by extrinsic factors, including lifting or holding external loads. Although the human spine typically maintains sagittal balance through compensatory mechanisms in static standing, these adaptations may be compromised during load-bearing activities, especially in those with CLBP. This becomes even more relevant in older adults who are more likely to experience age-related disc degeneration and sarcopenia, further impairing the spine’s ability to adapt to mechanical stress.

 
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