| 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
|
|
|
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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R293||Abnormal posture, |
|
|
Intervention / Comparator Agent
|
|
|
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. |