FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/11/077066 [Registered on: 19/11/2024] Trial Registered Prospectively
Last Modified On: 18/11/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   How Breast Size Affects Neck Pain and Posture in Adult Women 
Scientific Title of Study   Impact of Breast Size on Cervical Pain and Forward Head Posture in Adult Women: An Observational 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  tanushree lakshmikant 
Designation  student 
Affiliation  galgotias university 
Address  Plot No.2, Sector 17-A Yamuna Expressway, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh, India Opposite Buddh International Circuit.

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  7533927396  
Fax    
Email  tanushree.21smas1010016@galgotiasuniversity.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Neeraj Kumar 
Designation  Assistant Professor 
Affiliation  Galgotias University 
Address  Plot No.2, Sector 17-A Yamuna Expressway, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh, India Opposite Buddh International Circuit.

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  9810434830  
Fax    
Email  neerajkumar@galgotiasuniversity.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Neeraj Kumar 
Designation  Assistant Professor 
Affiliation  Galgotias University 
Address  Plot No.2, Sector 17-A Yamuna Expressway, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh, India Opposite Buddh International Circuit.


UTTAR PRADESH
203201
India 
Phone  9810434830  
Fax    
Email  neerajkumar@galgotiasuniversity.edu.in  
 
Source of Monetary or Material Support  
Galgotias University 
 
Primary Sponsor  
Name  Galgotias University 
Address  Plot No.2, Sector 17-A Yamuna Expressway, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh, India Opposite Buddh International Circuit. 
Type of Sponsor  Research institution 
 
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 
TANUSHREE LAKSHMIKANT  Galgotias University  Plot No.2, Sector 17-A Yamuna Expressway, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh, India Opposite Buddh International Circuit.
Gautam Buddha Nagar
UTTAR PRADESH 
7533927396

tanushree.21smas1010016@galgotiasuniversity.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Departmental Research Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R293||Abnormal posture,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Female participants aged 20-50 years.
Health Status No history of cervical spine surgery, significant spinal deformities (e.g., scoliosis), or major musculoskeletal disorders that could affect posture or cervical pain.
Breast Size Measurement Participants must have measurable breast sizes that allow them to
be categorized into smaller and larger breast size groups.
Lifestyle Group Undergraduate students, Working women, and Housewives
Consent-Willingness to provide informed consent to participate in the study, including
completion of all assessments.
 
 
ExclusionCriteria 
Details  Medical Conditions: History of chronic cervical or upper back conditions unrelated to breast size, such as severe arthritis or fibromyalgia, that could confound results.
Pregnancy or Recent Postpartum:
Current Treatment: Women currently undergoing treatment for cervical pain or undergoing
postural therapy that might influence study outcomes.
Breastfeeding. Uncontrolled Health Issues, Presence of uncontrolled health issues that could
interfere with the ability to complete the study assessments, such as uncontrolled
hypertension or cardiovascular conditions.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Neck pain  Neck pain will be assessed by using neck pain and disability scale with in 4 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Forward head posture  Forward head posture will be assessed by using MB ruler with in 4 weeks 
 
Target Sample Size   Total Sample Size="164"
Sample Size from India="164" 
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)   30/11/2024 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Cervical pain and forward head posture (FHP) are common musculoskeletal issues affecting women, often influenced by factors such as breast size. The cervical spine, which consists of seven vertebrae, supports the head and allows for mobility while protecting the spinal cord. Proper posture depends on the alignment of these vertebrae and the surrounding muscles, ligaments, and tendons. However, FHP disrupts this alignment, placing strain on the cervical spine and leading to pain. FHP is characterized by an anterior displacement of the head relative to the trunk, shifting the body’s center of gravity and causing the neck muscles, particularly the extensor group, to compensate for the forward weight. This increased strain can lead to discomfort and contribute to long-term musculoskeletal issues.

One of the factors that contribute to FHP and cervical pain in women is breast size. Large breasts add weight to the upper body, which may cause the body to adopt compensatory postural changes. To counterbalance the anterior load created by larger breasts, the head and neck move forward, leading to FHP. This altered posture places additional stress on the cervical spine, neck muscles, and upper back. Over time, the sustained stress caused by these postural changes can result in neck pain, stiffness, and muscular fatigue.

The relationship between breast size and cervical pain is primarily due to the mechanical effects of weight distribution. Larger breasts can shift the body’s center of gravity forward, which forces the spine into a more kyphotic posture, increasing the curvature of the thoracic spine and encouraging FHP. This biomechanical shift places undue stress on the muscles of the neck, especially the trapezius, levator scapulae, and other stabilizers of the cervical spine. Over time, this compensation can lead to chronic pain in the cervical region as well as discomfort in the shoulders and upper back.

To explore these effects more thoroughly, this research will segregate the sample into three distinct groups: undergraduate women, working women, and housewives. The total sample size will consist of over 160 women, with each group analyzed separately to determine whether differences in lifestyle and daily activities impact the relationship between breast size, FHP, and cervical pain. After studying all three groups, the results will be compared to derive a unified conclusion regarding the effects of breast size on posture and pain across different female populations.

To measure FHP, the Craniovertebral Angle (CVA) is one of the most commonly used techniques. The CVA is the angle formed by a horizontal line passing through the seventh cervical vertebra (C7) and a line drawn from the tragus of the ear to C7. A smaller CVA indicates a greater degree of FHP, signifying an abnormal head position. Photography is used in conjunction with the CVA method to capture images of the individual’s posture. These images allow for a non-invasive analysis of the head and neck alignment relative to the rest of the body, and MB ruler software can then be used to determine the exact angle of FHP. Photogrammetry, which involves capturing posture through photographic methods, is a widely accepted and accurate tool for postural assessments. This method provides reliable visual data that can be analyzed to understand the severity of FHP in relation to other factors such as breast size.

Cervical pain can be assessed using the Neck Pain & Disability Scale (NPDS), a tool designed to evaluate how neck pain impacts a person’s daily life and functional abilities. The NPDS consists of a series of questions that assess the extent to which neck pain interferes with activities such as lifting, personal care, reading, and work. The index provides a comprehensive view of the physical limitations caused by cervical pain and helps quantify its severity in relation to overall disability. By using this tool, the correlation between FHP, breast size, and cervical pain can be further explored, offering valuable insights into the impact of postural changes on quality of life.

Breast size is typically measured using a measuring tape to determine both the band size and cup size. The measuring tape method involves taking measurements of the chest circumference just under the bust to determine the band size, and across the fullest part of the bust to determine cup size. These measurements provide a practical means of estimating breast size and understanding how it may contribute to postural changes and cervical pain.

In summary, larger breast size can lead to compensatory postural changes, like FHP, which often results in cervical pain. The CVA and photography provide accurate measurements of FHP, while the NPDS captures the impact of cervical pain on daily life. Together with simple breast size measurements, these tools offer a clear understanding of how breast size affects posture and contributes to neck pain.

 
Close