| CTRI Number |
CTRI/2024/09/073556 [Registered on: 06/09/2024] Trial Registered Prospectively |
| Last Modified On: |
30/08/2024 |
| 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
|
In the these study i have taken 2 groups group A experimental group will do mat pilates exresice and group B will do conventional group will do normal exrersice. |
|
Scientific Title of Study
|
Effect of Mat Pilates
Exercise on Pain, Disability and Neck Posture in Subjects with 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 |
Vaishnavi Deogude |
| Designation |
MPT scholor |
| Affiliation |
Parul institute of physiotherapy |
| Address |
Room no 309 3 nd floor Department of Physiotharapy parul university
post limda waghodia Gujarat
Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9825951745 |
| Fax |
|
| Email |
devgudevaishanvi17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavana Gadhavi |
| Designation |
Dean and principal |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Room no 309 3 nd floor Department of Physiotharapy parul university
post limda waghodia Gujarat
Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9727729787 |
| Fax |
|
| Email |
bhavana.gadhavi28222@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhavana Gadhavi |
| Designation |
Dean and principal |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Room no 309 3 nd floor Department of Physiotharapy parul university
post limda waghodia Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9727729787 |
| Fax |
|
| Email |
bhavana.gadhavi28222@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Room no 309 3 nd floor Department of Physiotharapy Parul university post limda waghodia Gujarat, 391760 India |
|
|
Primary Sponsor
|
| Name |
Parul University |
| Address |
Room no 309 3 nd floor Department of Physiotharapy parul university
post limda waghodia Gujarat,
391760 India |
| Type of Sponsor |
Private medical college |
|
|
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 Vaishnavi Deogude |
Parul Institute of Polytechnic |
Room no 309 3rd floor Department of Physiotharapy parul university
post limda waghodia Gujarat
Vadodara
GUJARAT |
9825951745
devgudevaishanvi17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul University Institutional Ethics Committee For Human Research(PU-IECHR) |
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 |
coventional exersice |
3 days in week for 6 weeks |
| Intervention |
Mat pilates exercise
|
3 days in a week for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1) Age group of 18 to 25 years.
2) Pain more than 3 months.
3) NPRS Scoring with minimum score of 3 and maximum score of 6.
4) Craniovertebral angle (CVA)- nromal range: 48 to 50 degree |
|
| ExclusionCriteria |
| Details |
1. History of Recent injury or Trauma.
2. Neurological Condition or Disorder.
3. History of Specific treatment (eg: Taking medication for neck pain) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
|  Craniovertebral Angle Sacle. |
3 days in a week for 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
 Numeric Pain Rating Scale (NPRS)
 Neck Disability Index.(NDI) |
1 day , last day in 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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 |
|
Date of First Enrollment (India)
|
18/09/2024 |
| 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
|
Pilates is another common type of mindbody exercises that focuses on posture ,respiration and coordinated movement. Previous studies have demonstrated that patients with neck pain may have impairments in the flexors and extensor crevical muscles (eg: trepazites,Levator Scapulae,Sternocleidomastoid Muscles,Scalene Muscles) responsible for maintaining the neck posture and sability of neck. Due to the interdependence of muscle chains in the spinal region, postural disorders in the craniocervical region cause postural compensations in other segments of the spinal region. Pilate’s workouts have been used to improve neck muscles through exercises that increase strength and stability of the muscles. Related to biomechanical disorders, local symptoms such as decreasing cervical joint movements, muscle strength imbalance, fatigue, shortening of muscles, pain and degenerative changes in joints occur. Conventional therapy is effective in reduceing pain whereas combimination of both the techniques will improve neck posture, flexibilty, disability and muscle activity. Previous study have not shown any effect of mat pilates on chronic cervical spine so in this study we are going to find the effect of mat pilates on cervical pain and disability. |