| CTRI Number |
CTRI/2025/09/094109 [Registered on: 02/09/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| 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
|
Comparison of Back School Program and Neck Activation Exercises for Reducing Pain Improving Endurance and Enhancing Quality of Life in middle age women with Non-Specific Neck Pain |
|
Scientific Title of Study
|
EFFECT OF BACK SCHOOL BASED INTERVENTION VS NECK ACTIVATION EXERCISES ON PAIN ENDURANCE AND QUALITY OF LIFE IN NON-SPECIFIC NECK PAIN A COMPARATIVE 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 |
Sayali Mahulkar |
| Designation |
PG Student |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Parul University Rehab OPD Room No.232 Post Office Limda Taluka Waghodia District Vadodara 391760
Parul University Rehab OPD Room No.232 Post Office Limda Taluka Waghodia District Vadodara 391760
Vadodara
GUJARAT
391760
India |
| Phone |
7499246954 |
| Fax |
|
| Email |
sayalimahulkar06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nilesh Parmar |
| Designation |
Assistant Professor |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Parul University Rehab OPD Room No.232 Post Office Limda Taluka Waghodia District Vadodara 391760
Parul University Rehab OPD Room No.232 Post Office Limda Taluk Waghodia District Vadodara 391760
Vadodara
GUJARAT
391760
India |
| Phone |
7499246954 |
| Fax |
|
| Email |
nilesh.parmar28182@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Sayali Mahulkar |
| Designation |
PG Student |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Parul University Rehab OPD Room No.232 Post Office Limda Taluka Waghodia District Vadodara 391760
Parul University Rehab OPD Room No.232 Post Office Limda Taluka Waghodia District Vadodara 391760
Vadodara
GUJARAT
391760
India |
| Phone |
7499246954 |
| Fax |
|
| Email |
sayalimahulkar06@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Physiotherapy
P.O.Limda Tal.Waghodia Dist.Vadodara 391760 |
|
|
Primary Sponsor
|
| Name |
Parul institute of Physiotherapy Parul university |
| Address |
Parul institute of Physiotherapy Parul university Limda Waghodia Vadodara Gujrat 391760 |
| 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 |
| Sayali Mahulkar |
Parul Sevashram Hospital Rehab OPD Room No 232 |
Parul University Rehab OPD Room No 232 Post Office Limda Taluka Waghodia District Vadodara 391760
Vadodara
GUJARAT |
7499246954
sayalimahulkar06@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 |
| Patients |
(1) ICD-10 Condition: M709||Unspecified soft tissue disorder related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Back School based intervention |
Neck Isometric Exercises 10 repetions with 10 second hold
Scapular Stability Exercises10 repetions with 5 second hold
light theraband exercises for resistance (yellow) 5repetions with 10 second hold
moderate theraband exercise for resistance (red)
5 repetions with 10 second hold
total time required - 40-45 mins
frequency - 4 days per week |
| Comparator Agent |
Neck Activation Exercises |
Deep neck flexor stabilizers neck extensors chin tucks head nods cervical isometrics
each exercise 10 repetitions with 5 second hold
repetion 10 repetions with 5 sec hold
frequency 4 times per week |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Middle aged women 35 to 60 years
diagnosis of non specific neck pain since 1 month
pain intensity of at least 3 on NPRS scale
Ability to understand and follow exercise instruction |
|
| ExclusionCriteria |
| Details |
History of trauma neurological disorder
inflammatory arthritis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numerical Pain Rating scale
Neck Disability Index
Quality of life |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
19/09/2025 |
| 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 Applicable |
| 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
|
Non-specific neck pain is common and often linked to poor posture muscle imbalance and weak shoulder girdle stability. Conventional therapies usually focus on general strengthening which may not address neuromuscular control. Neck activation exercises improve proprioception strength and pain by integrating shoulder and neck mechanics while back school–based programs emphasize posture ergonomics and exercise to enhance pain relief endurance and quality of life. However limited studies directly compare these two approaches. This study aims to evaluate their effectiveness providing evidence to guide better rehabilitation strategies for non-specific neck pain. The study will include middle-aged women with non-specific neck pain selected through screening based on inclusion and exclusion criteria after obtaining informed consent. Participants will be randomly divided into two groups one receiving neck activation exercises and the other receiving back school–based cervical interventions. After the intervention post-assessment will be conducted and the results of both groups will be compared. |