| CTRI Number |
CTRI/2024/09/073628 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
08/09/2024 |
| 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
|
Stretching of back and leg muscles to reduce neck pain
|
|
Scientific Title of Study
|
Effect Of Posterior Sagittal Chain Release Technique on Pain and Range Motion in non specific neck Pain in IT students of Parul university An Experimental 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 |
Chanchal Halu |
| Designation |
MPT Scholar |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Room no. 309 , 3rd floor, Parul Institute Of Physiotherapy, Parul University, Post Limda, Waghodia, Gujarat, India.
Vadodara
GUJARAT
391760
India |
| Phone |
8871892609 |
| Fax |
|
| Email |
haluchanchal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrNilesh M Parmar |
| Designation |
Assistant professor |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Room no. 309 , 3rd floor, Parul Institute Of Physiotherapy, Parul University, Post Limda, Waghodia, Gujarat, India.
Vadodara
GUJARAT
391760
India |
| Phone |
9913589719 |
| Fax |
|
| Email |
nilesh.parmar28182@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DrNilesh M Parmar |
| Designation |
Assistant professor |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Room no. 309 , 3rd floor, Parul Institute Of Physiotherapy, Parul University, Post Limda, Waghodia, Gujarat, India.
GUJARAT
391760
India |
| Phone |
9913589719 |
| Fax |
|
| Email |
nilesh.parmar28182@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| room no. 309 , 3rd floor, parul institute of physiotherapy, parul university, post limda, waghodia,
gujarat, India
Pincode 391760 |
|
|
Primary Sponsor
|
| Name |
Dr.Chanchal Halu |
| Address |
room no. 309 , 3rd floor, parul institute of physiotherapy, parul university, post limda, waghodia,
gujarat |
| 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 |
| DrChanchal Halu |
Parul University |
Parul institute of physiotherapy ,room no. 301 3rd floor Parul university post limda waghodia
Vadodara
GUJARAT |
8871892609
391760
haluchanchal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| parul university institutional ethics committee for human research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
non specific neck pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
physiotherapy treatment |
2weeks for 6months
Therapeutic ultrasound and massage |
| Intervention |
Posterior chain release |
2weeks for 6months
gastrocnemius stretching, hamstring stretch, thoracolumbar stretch , neck extensor stretch |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Age : 18 – 30 years
Both Male and female
Subacute or Chronic Neck Pain
Reduced Neck Flexion ROM |
|
| ExclusionCriteria |
| Details |
Post traumatic injury.
Previous cervical spine surgery,
Cervical radiculopathy, presence of a severe systemic disease
Fibromyalgia, or other widespread musculoskeletal pain syndromes
Had participated in an exercise program for the neck muscles in the 6 months preceding
the study
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Scale for Pain Assessment, Neck Disability Index to assess neck disability |
5 sessions/week for 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cervical Goniometer for assessment of Range Of Motion of Neck |
5 sessions/week for 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="63"
Sample Size from India="63"
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)
|
20/09/2024 |
| 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 Yet Recruiting |
| 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
|
Aim : To Find Effectiveness Of Posterior sagittal chain release on non specific Neck pain
Introduction : Neck Pain Has Considerable Implication For Health And Quality of life and is a well recognized source of disability in working population .The long-term , lower intensity stress and strain and in proper posture are believed to be the most important causative factor for neck pain, duration of computer use ,frequency of breaks , method of key board operation ,and position of computer monitor are also associated with neck pain at work . computer users with neck pain had reduced activity of cervical extensors muscles and higher activity in the upper trapezius compared to workers without neck pain
Need of Study : There have been many studies and techniques to improve neck pain but there are very few studies explaining the effect of posterior sagittal chain release on neck pain and range of motion .
Procedure : After Taking approval from CTRI and Ethical committee informed consent forms will be taken from the computer workers and pre assessment will be done according to inclusion criteria . participants will be divided into control and experimental group and experimental group will receive posterior sagittal chain release for 2 weeks 5 sessions/week. and post assessment will be taken after 2 weeks. |