| 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
|
|
|
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
|
|
|
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
- 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 - Informed Consent Form Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- 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 28-01-2028 and end date provided 28-01-2045?
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) 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. |