| CTRI Number |
CTRI/2025/02/080263 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
24/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Neck Posture and Endurance: A Cross-Sectional Study on Individuals with and without Neck Pain |
|
Scientific Title of Study
|
Relationship between neck posture and neck endurance level among subjects with and without neck pain: A cross-sectional 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 |
SOWMYA R |
| Designation |
Under graduate |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research[Deemed to be university] |
| Address |
Faculty of Physiotherapy, Room No 4.3, Floor 4, Sri Ramachandra
Institute of Higher Education and Research[Deemed to be university],Porur,Chennai-600116,Tamil Nadu, India.
Chennai
TAMIL NADU
600116
India |
| Phone |
6383618413 |
| Fax |
|
| Email |
sowmya20021130@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Soundararajan |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research[Deemed to be university] |
| Address |
Faculty of Physiotherapy, Room No 2.3, Floor 2, Sri Ramachandra
Institute of Higher Education and Research[Deemed to be
university],Porur,Chennai-600116,Tamil Nadu, India
Chennai
TAMIL NADU
600116
India |
| Phone |
9551163416 |
| Fax |
|
| Email |
soundararajan.k@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
RAGAVENDIRAN P |
| Designation |
Under graduate |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research[Deemed to be university] |
| Address |
Faculty of Physiotherapy, Room No 4.3, Floor 4, Sri Ramachandra
Institute of Higher Education and Research[Deemed to be university],Porur,Chennai-600116,Tamil Nadu, India.
Chennai
TAMIL NADU
600116
India |
| Phone |
9150474768 |
| Fax |
|
| Email |
ragavendiranpragavendiranp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of Physiotherapy,Sri Ramachandra Institute of Higher Education and Research[Deemed
to be university],Porur,Chennai-600116,Tamil Nadu,India |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research[Deemed to be university] |
| Address |
Faculty of Physiotherapy,Sri Ramachandra Institute of Higher
Education and Research[Deemed to be
university],Porur,Chennai-600116,Tamil Nadu,India |
| Type of Sponsor |
Private 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 K Soundararajan |
Sri Ramachandra Hospital |
Faculty of Physiotherapy, Room No 2.3, Floor 2, Sri Ramachandra
Institute of Higher Education and Research[Deemed to be
university],Porur,Chennai-600116,Tamil Nadu, India.
Chennai
TAMIL NADU |
9551163416
soundararajan.k@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Students Project, Faculty of Physiotherapy,Sri Ramachandra Institute of Higher Education and Research[Deemed to be university],Porur, Chennai-600116,Tamil Nadu,India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M542||Cervicalgia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects identified with neck pain.
2.Age ≥18 years including both men and women |
|
| ExclusionCriteria |
| Details |
1.Known inflammatory spinal pathology
2.Cervical radiculopathy
3.Subjects who had spinal fracture or surgery
4.Pregnant women
5.Severe neck pain or disability
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Patient-Specific Functional Scale
Neck Disability Index
Patient specific activity scoring scheme |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Visual Analogue Scale
|
At baseline |
| Neck Muscle Endurance |
At Baseline |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
10/02/2025 |
| 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)
|
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
|
BACKGROUNDThe prevalence of neck pain is increasing globally, ranking second to low back pain among musculoskeletal disorders, with an estimated 2,696 cases per 1,000,000 individuals. This condition can lead to significant disability. Proper neck posture is crucial for aligning the cervical spine, reducing strain on muscles and ligaments. Good posture helps distribute the head’s weight evenly, preventing pain and stiffness, while poor posture can result in muscle imbalances, increased tension, headaches, and nerve compression. Muscle endurance is important for maintaining good neck posture. Although deep cervical flexor endurance doesn’t directly relate to posture, individuals with neck pain often show lower muscle endurance.The rise in electronic device usage has contributed to "tech neck," characterized by Forward Head Posture (FHP) and increased strain, particularly among children. Despite its prevalence, studies have not definitively linked cervical posture and neck pain. This study aims to investigate the relationship between neck posture and muscle endurance in individuals experiencing neck pain.
AIM: To study the relationship between neck posture and neck endurance level among subjects with and without neck pain.
OBJECTIVE: Primary objective:  To compare neck posture and neck endurance in subjects with and without neck pain using Kinovea software, Neck Flexor and Extensor Endurance Tests and Chattanooga pressure biofeedback device. Secondary objective:  To analyse the intensity of pain in the subjects with neck pain through visual analogue scale.  To examine the functional performance through Neck Disability Index and Patient specific Functional Scale.
NEED FOR THE STUDY: Even though studies have said about the relationship between the cervical posture and muscle endurance in neck pain patient continued research in this area is critical for advancing our understanding of neck pain mechanism. PROCEDURE: Institutional Ethical Committee, SRIHER will be obtained and the study will be registered in Clinical Trial Registry of India. The participants will be screened for eligibility criteria. Once participants fulfills inclusion criteria, informed consent will be obtained and participants undergo baseline assessments to collect demographic information, medical history,. The participants will be assigned as subjects with and without neck pain. Participants with neck pain undergo additional assesment of pain intensity through Visual Analogue scale (VAS). Objective measurements of neck posture thatis the craniovertebral angle is obtained using Kinovea software. Neck endurance is assessed using standardized endurance tests (CFET, CEET), Chattanooga pressure biofeedback. The functional performance is analysed through Neck Disability Index and Patient-specific functional scale. The obtained results of endurance and craniovertebral angle are compared within the two groups. |