| CTRI Number |
CTRI/2022/03/041542 [Registered on: 31/03/2022] Trial Registered Prospectively |
| Last Modified On: |
31/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of Suboccipital muscle release with active chin tuck exercise in Young adults with neck pain. |
|
Scientific Title of Study
|
Effectiveness of Suboccipital muscle release with active chin tuck exercise versus conventional exercises on Forward head posture, Pain and Disability in Young adults with Text-Neck Syndrome - A Randomized Controlled Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Balin Prasanna B |
| Designation |
PG student |
| Affiliation |
The Oxford College Of Physiotherapy |
| Address |
6/9, The oxford college of physiotherapy, 1st cross begur road, Hongasandra, bommanahalli, bengaluru - 560068
Bangalore
KARNATAKA
560068
India |
| Phone |
7904407883 |
| Fax |
|
| Email |
prasannabalakrishnan1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Balin Prasanna B |
| Designation |
PG student |
| Affiliation |
The Oxford College Of Physiotherapy |
| Address |
6/9, the Oxford college of physiotherapy, 1st cross begur road, Hongasandra, bommanahalli, bengaluru - 560068
Bangalore
KARNATAKA
560068
India |
| Phone |
7904407883 |
| Fax |
|
| Email |
prasannabalakrishnan1997@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Krishna Muralidharen |
| Designation |
Lecturer |
| Affiliation |
The Oxford College Of Physiotherapy |
| Address |
6/9, The Oxford college of physiotherapy, 1st cross begur road, Hongasandra, bommanahalli, bengaluru - 560068
Bangalore
KARNATAKA
560068
India |
| Phone |
6362458697 |
| Fax |
|
| Email |
krishnamuralee18@gmail.com |
|
|
Source of Monetary or Material Support
|
| 6/9,The Oxford college of Physiotherapy, 1st cross, begur main road, Hongasandra, Bangalore - 560068 |
|
|
Primary Sponsor
|
| Name |
Balin Prasanna B |
| Address |
6/9, 1st cross begur road, hongasandra, bommanahalli, bengaluru - 560068 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Krishna Muralidharen |
The Oxford college of Physiotherapy |
no. 6/9, physiotherapy department, hongasandra, bangalore- 560068
Bangalore
KARNATAKA |
6362458697
krishnamuralee18@gmail.com |
| Dr Krishna Muralidharen |
The Oxford college of Physiotherapy |
no. 6/9, physiotherapy department, hongasandra, bangalore- 560068
Bangalore
KARNATAKA |
6362458697
krishnamuralee18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The oxford college of physiotherapy review board for ethics and research (TOCPTRBER) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M540||Panniculitis affecting regions ofneck and back, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
stretching: upper trapezius, levator scapulae and pectoralis. Strengthening: Rhomboids, lower trapezius, serratus anterior.
The stretching and strengthening will be designed based on FITT principle.
|
it improves ROM and reduces pain. It is a 25 minutes session per day (2-3 days per week) for 4 weeks |
| Intervention |
suboccipital muscle release with active chin tuck exercise |
To reduce the pain and improve ROM. It is a 25 minutes session per day (2-3 days per week) for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having neck pain more than one week
2. Subjects working on or uses electronics (mobiles / computers) for more than 4 hours for sustained period of time
3. Cranio vertebral angle ≤ 50â°
|
|
| ExclusionCriteria |
| Details |
1. Subjects who had undergone any surgery or injury around the neck or shoulder for past 6 months.
2. Subjects having congenital short neck wry neck, torticollis.
3. Subjects having asymmetrical spinal curvature like increased structural kyphosis, lordosis and scoliosis.
4. Subjects undergoing medications for any form of headaches like vascular, tensional or migraine.
5. Subjects having headache and neck pain due to ophthalmic problem.
6. Uncooperative patient |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cranio vertebral angle |
At the baseline, after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Neck disability index |
At the baseline, after 4 weeks |
| Numerical pain rating scale |
At the baseline, After 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
31/03/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/03/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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†is a repetitive stress injury or
an overuse syndrome where a person has their head hung or flexed in a forward
position and is bent down looking at their smartphone for prolonged period of
time. Technology advances in the recent decades has associated with
the evolution of new medical syndromes due to the prolonged use of electronics.
One of these syndromes is Text Neck syndrome.
If Text
neck syndrome is untreated it can lead to some serious permanent damage such as
Flattening of the spinal curve, Onset of early arthritis, Spinal misalignment, Spinal
degeneration, Disc compression, Disc herniation, Nerve damage, Muscle damage.
According to a systematic review done in 2017 by Sunil Neupane et al., he has
concluded that more studies are needed in this area. So the purpose of this study is to find out the effectiveness of suboccipital muscle release with active chin tuck exercise versus conventional exercises on forward head posture, pain and disability in young adults with Text-Neck syndrome. |