| CTRI Number |
CTRI/2023/06/053945 [Registered on: 16/06/2023] Trial Registered Prospectively |
| Last Modified On: |
15/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Supervised Exercise] |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of supervised exercise on neck pain & functional disability |
|
Scientific Title of Study
|
EFFECTIVENESS OF SUPERVISED EXERCISES ON NECK PAIN AND FUNCTIONAL DISABILITY AMONG STUDENTS WITH TEXT NECK SYNDROME IN A SELECTED INSTITUTIONS AT MANGALURU |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sageera Hashmath K M |
| Designation |
Msc Nursing |
| Affiliation |
Father muller college of nursing |
| Address |
16th cross road karolgudde jodukatte miyar post karkala udupi district
father muller road kankanady manglaore 575002
Dakshina Kannada
KARNATAKA
574107
India |
| Phone |
9108485949 |
| Fax |
|
| Email |
hashmathsageera@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Susamma Varughese |
| Designation |
Professor |
| Affiliation |
Father muller college of nursing |
| Address |
Father muller college of nursing
father muller road kankanady manglaore 575002
father muller road kankanady manglaore 575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8495824303 |
| Fax |
0824-2438906 |
| Email |
srjudya@fathermuller.in |
|
Details of Contact Person
Public Query
|
| Name |
Sageera Hashmath K M |
| Designation |
Msc Nursing |
| Affiliation |
Father muller college of nursing |
| Address |
16th cross road karolgudde jodukatte miyar post karkala udupi district
father muller road kankanady manglaore 575002
Dakshina Kannada
KARNATAKA
574107
India |
| Phone |
9108485949 |
| Fax |
|
| Email |
hashmathsageera@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sageera hashmath k m
Father muller college of nursing
kankanady mangalore 575002 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [Self Funded] |
|
|
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 Susamma Varughese |
Father muller college of nursing |
Lecture hall no : 8,3 and 2
Department of medical surgical nursing
father mullers road
kankanady
mangalore 575002
Dakshina Kannada
KARNATAKA |
8495824303
0824-2438906
srjudya@fathermuller.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Ethical Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Supervised Exercise |
Supervised Exercises will be given to the students for 14 days with textneck syndrome. |
| Comparator Agent |
Supervised Exercises |
Supervised Exercises will be given to the students for 14 days with text neck syndrome. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
- Students who are using handheld devices more than 2 hours/day and having mild to moderate neck ache with mild and moderate functional disability
-Students who are between the age group of 18-24 years
-Subjects will be included in the study based on symptoms not by medical diagnosis
-Students who are having any two symptoms in the screening tool
|
|
| ExclusionCriteria |
| Details |
- Those who already have severe neck pain
- Those with severe functional disability
- Those who are experiencing neck ache less than 1 week and more than 3 months
- Neck pain due to any other pathological or non-pathological causes including fall, injury, fractures and sprain etc
- Those who are on analgesics |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| After the intervention neck pain will be reduced |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| After the intervention functional disability will be reduced |
14 days |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
23/06/2023 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Text
Neck has been emerging as a rapidly evolving global non communicable pandemic
affecting millions of people across the world. Excessive use of handheld
devices like gadgets and mobiles is leading to harmful effects on the human
life, one result is known as Text Neck. The
term text neck does not necessarily imply only to the consequences of texting
and over use of cell phones. It can indeed be seen with prolonged duration of
usage of tablets, e-readers, digital camera and numerous other handheld gadgets
and electronic devices in which information science technology has been
designated for just about every application. The predominant symptoms are aches
and pains (which can be noted in neck, shoulder, arm, back, fingers, wrists and
elbows), headaches, numbness and tingling of upper extrimities.
|
Text neck
syndrome is a global musculoskeletal problem in relation to all ages because
of the use of hand handheld devices like gadgets, mobile phones etc. With the
advent of growing science and information technology, young adults have grown
up today with the use of such hand held devices as an evident part of their
life. Hence text neck
syndrome contributes as to a major cause to the burden of pain in neck region
and frailty. Investigator noticed many cases of young adults suffering from
such symptoms of text neck syndrome and considered the importance in training
the simple supervised isometric movements in decreasing the burden of neckline
pain and frailty in text neck syndrome.
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|