| CTRI Number |
CTRI/2021/08/035642 [Registered on: 13/08/2021] Trial Registered Prospectively |
| Last Modified On: |
09/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Virtual rehabilitation for neck pain |
|
Scientific Title of Study
|
Effectiveness of telerehabilitation in forward head posture with neck pain among adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amita Aggarwal |
| Designation |
Associate Professor |
| Affiliation |
Dr. D.Y. Patil Vidyapeeth ,Pune |
| Address |
Department of Kinesiology,ist cabin,3rd floor
Dr. D.Y. Patil College of Physiotherapy,Sant Tukaram Nagar,Pimpri,Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7986972513 |
| Fax |
|
| Email |
amita15pgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amita Aggarwal |
| Designation |
Associate Professor |
| Affiliation |
Dr. D.Y. Patil Vidyapeeth ,Pune |
| Address |
Department of Kinesiology,ist cabin,3rd floor
Dr. D.Y. Patil College of Physiotherapy,Sant Tukaram Nagar,Pimpri,Pune
MAHARASHTRA
411018
India |
| Phone |
7986972513 |
| Fax |
|
| Email |
amita15pgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rasika Kad |
| Designation |
PG Student |
| Affiliation |
Dr. D.Y. Patil Vidyapeeth ,Pune |
| Address |
PG 1 Classroom, 3rd floor,
Dr. D.Y. Patil College of Physiotherapy,Sant Tukaram Nagar,Pimpri,Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9975105062 |
| Fax |
|
| Email |
rasikakad9003@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D.Y. Patil College of Physiotherapy,Pune |
|
|
Primary Sponsor
|
| Name |
Amita Aggarwal |
| Address |
Department of Kinesiotherapy Ist cabin 3rd floor , Dr. D.Y. Patil College of Physiotherapy,Sant Tukaram Nagar,Pimpri,Pune,Maharashtra.411018 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Amita Aggarwal |
Dr. D.Y. Patil College of Physiotherapy,Pune |
Physiotherapy OPD,Basement,Dr. D.Y. Patil College of Physiotherapy,Pimpri Chinchwad
Pune
MAHARASHTRA |
7986972513
amita15pgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. D.Y. Patil Vidyapeeth,Pune |
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 |
| Comparator Agent |
Conventional protocol |
Warm up (10 min) which includes stretching of neck muscles (upper trapezius, scalenes, suboccipital, Sternocleidomastoids and the Levator scapulae) 1 set ,30 seconds hold,3 repetitions 1. Supine position and side lying position Neck curl with chin tucked Neck lateral bending with chin tucked 2. In sitting Head pushing against palm with chin tucked Neck bending on the diagonal with chin tucked 3 session per week of exercise will be given for 6weeks for 30 minutes |
| Intervention |
Telerehabilitation for Forward head posture with neck pain |
Warm up (10 min) which includes stretching of neck muscles (upper trapezius, scalenes, suboccipital, Sternocleidomastoids and the Levator scapulae) 1 set ,30 seconds hold,3 repetitions
1. Supine position and side lying position
Neck curl with chin tucked
Neck lateral bending with chin tucked
2. In sitting
Head pushing against palm with chin tucked
Neck bending on the diagonal with chin tucked
3 session per week of exercise will be given for 6weeks for 30 minutes |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
44.00 Year(s) |
| Gender |
Both |
| Details |
Individuals within age group of 25 TO 44 years ,Forward head posture with CV angle below 48 degree, Chronic Neck pain (NDI ≥ 14),Both genders,Individuals those who are spending minimum 4 hours in a day on smartphone or desktop
|
|
| ExclusionCriteria |
| Details |
• Deformity of spine
• Spinal cord compression
• Neck injuries or recent trauma to cervical region
• Recent surgery of neck region
• Thoracic outlet syndrome
• Malignancy
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numerical pain rating scale(NPRS),Craniovertebral angle(CV angle),Cervical range of motion and Neck disability index(NDI) |
At baseline and at 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Shoulder angle and head angle |
Pre and after 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
18/08/2021 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Null
hypothesis (H0): ·
There will be no significant difference between telerehabilitation
and conventional outpatient physical therapy in forward head posture with neck
pain among adults Alternative
hypothesis (H1):
·
There will be significant difference between
telerehabilitation and conventional outpatient physical therapy on forward head
posture with neck pain among adults
AIM: To see the
effectiveness of telerehabilitation in forward head posture with neck pain among
adults
Objectives:
1. To
determine the effect of telerehabilitation in forward head posture with neck
pain among adults.
2. To
determine the effect of conventional outpatient physical therapy in forward
head posture with neck pain among adults
3. To
compare the telerehabilitation verses conventional outpatient physical therapy
in forward head posture with neck pain among adults.
|