| CTRI Number |
CTRI/2024/11/077277 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
28/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Analyse the association between pain, activity of daily living and stress in patients with neck pain |
|
Scientific Title of Study
|
Correlation Between Pain Intensity, Disability, and Pain-Related Psychological Characteristics
in Patients with Chronic Neck Pain. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nithin Prakash |
| Designation |
PhD Scholar |
| Affiliation |
Manipal hospitals |
| Address |
Department of Physiotherapy,Out Patient Service, Upper basement, Manipal Hospital #98, HAL,Old Airport Road, Bangalore India
Bangalore
KARNATAKA
560017
India |
| Phone |
9915803047 |
| Fax |
|
| Email |
nithinprakash8891@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H Karvannan |
| Designation |
Head & Professor |
| Affiliation |
Manipal hospitals |
| Address |
Department of Physiotherapy,Out Patient Service, Upper basement, Manipal Hospital #98, HAL,Old Airport Road, Bangalore India
Bangalore
KARNATAKA
560017
India |
| Phone |
9986565966 |
| Fax |
|
| Email |
karvannan.h@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr H Karvannan |
| Designation |
Head & Professor |
| Affiliation |
Manipal hospitals |
| Address |
Department of Physiotherapy,Out Patient Service, Upper basement, Manipal Hospital #98, HAL,Old Airport Road, Bangalore India
KARNATAKA
560017
India |
| Phone |
9986565966 |
| Fax |
|
| Email |
karvannan.h@manipal.edu |
|
|
Source of Monetary or Material Support
|
| No.98, Rustam Bhag Road, Old Airport Road,Department of Physiotherapy, Maniapl College of
Health Professions, Manipal Academy of Higher Education, Bangalore 560017 |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
No.98, Rustam Bhag Road, Old Airport Road,Department of Physiotherapy, Maniapl College of
Health Professions, Manipal Academy of Higher Education, Bangalore 560017 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Nithin Prakash |
Manipal Hospitals Bangalore |
Department of
Physiotherapy,Out
Patient Service, Upper
basement, , Manipal
Hospital #98, HAL,Old
Airport Road,
Bangalore India
Bangalore
KARNATAKA |
9915803047
nithinprakash8891@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committe of Manipal Hospitals, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Chronic Neck pain patients more than 3 months. NPRS greater than 3
Cervical region pain (symptoms isolated to neck) Restricted Range of Motion |
|
| ExclusionCriteria |
| Details |
Patients with serious neck pathologies (cervical myelopathy, neoplastic conditions,
upper cervical ligamentous instability, vertebral artery insufficiency, inflammatory or
systemic diseases)
Patients with history of Cervicogenic headache
Patients with Radiculopathy symptoms
Any recent Trauma to upper extremity or neck including History of Whiplash Injury.
Previous surgery to neck or shoulder
Shoulder impingement or upper quadrant dysfunction
Rotator cuff pathology
Thoracolumbar fascia tightness
Shoulder pain or neck pain due to Cardiovascular pathology. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numerical Pain Rating Scale (NPRS)
Neck Disability Index (NDI)
OSPRO-YF (Optimal Screening for Prediction of Referral and Outcome Yellow Flag) |
Baseline assessment (0 weeks- at time of enrollment) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| OSPRO-YF (Optimal Screening for Prediction of Referral and Outcome Yellow Flag) |
Baseline assessment (0 weeks- at time of enrollment) |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
16/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/12/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
Chronic neck pain is a prevalent condition with multifactorial etiology, including physical
strain, poor posture, mental stress, and various musculoskeletal pathologies. It significantly
affects daily activities and quality of life, often necessitating a multidisciplinary approach to
management. Psychological distress, encompassing anxiety, depression, and stress, has been
consistently linked with chronic neck pain, emphasizing the importance of addressing
psychological factors in its assessment and management. Furthermore, disability is closely
associated with chronic neck pain, albeit the relationship between pain intensity and disability
remains intricate. Psychological distress has been identified as a significant contributor to
disability in individuals with neck pain. However, the interplay between pain intensity,
disability, and pain-related psychological characteristics in chronic neck pain patients has not
been extensively studied. Therefore, this research aims to investigate the correlation between
these factors to enhance our understanding and improve patient care. |