| CTRI Number |
CTRI/2025/03/082353 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| 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
|
Effect of Neck Muscles Stretching on Gut and Nervous System in Patients with Bad Posture |
|
Scientific Title of Study
|
Efficacy of Sub Occipital and Upper Trapezius Muscle Release on Various GI and Autonomic Parameters in Patients with Upper Cross Syndrome
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mahima |
| Designation |
student |
| Affiliation |
Department of Physiotherapy Guru Jambheshwar University ofScience and Technology, Hisar |
| Address |
Department of Physiotherapy Guru Jambheshwar University Of science and Technology
Hisar
haryana
Pin- 125001
(India)
HARYANA,Pin- 125001,(India)
Hisar
HARYANA
125001
India |
| Phone |
9053908624 |
| Fax |
|
| Email |
sainimahima555@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manoj malik |
| Designation |
Assistant Professor |
| Affiliation |
Department of Physiotherapy Guru Jambheshwar University ofScience and Technology, Hisar |
| Address |
Department of Physiotherapy Guru Jambheshwar University Of science and Technology
Hisar
haryana
Pin- 125001
(India)
HARYANA,Pin- 125001,(India)
Hisar
HARYANA
125001
India |
| Phone |
9896221262 |
| Fax |
|
| Email |
malik_manoj@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Manoj malik |
| Designation |
Assistant Professor |
| Affiliation |
Department of Physiotherapy Guru Jambheshwar University ofScience and Technology, Hisar |
| Address |
Department of Physiotherapy Guru Jambheshwar University Of science and Technology
Hisar
haryana
Pin- 125001
(India)
HARYANA,Pin- 125001,(India)
Hisar
HARYANA
125001
India |
| Phone |
9896221262 |
| Fax |
|
| Email |
malik_manoj@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Mahima Saini MPT Student Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar Haryana India 125001 |
|
|
Primary Sponsor
|
| Name |
Department of Physiotherapy |
| Address |
Guru Jambheshwar University of Science and Technology Hisar Haryana India 125001 |
| Type of Sponsor |
Research institution |
|
|
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 Manoj Malik |
Guru Jambheshwar University of Sciece and Technoloy |
OPD room no.4
Department of Physiotherapy Guru Jambheshwar University,
Hisar
HARYANA
Hisar
HARYANA |
9896221262
malik_manoj@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of Guru Jambheshwar University of Science and Technology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R299||Unspecified symptoms and signs involving the nervous and musculoskeletal systems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Isometric Exercises, Trans Cutaneous Electrical Nerve Stimulation and Hot pack |
Patients in this group will be given Isometric Exercises, Trans cutaneous electrical nerve stimulation and Hot pack for 3 sessions per week for 4 weeks. |
| Intervention |
Myofascial release and Hot pack |
Patients in this group will be given Myofascial release and Hot pack for 3 sessions per week for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Age group 20-40 year
Both Males and females will be included in the study
Neck pain from last 2-3 months
Participants with trigger point in upper Trapezius muscle (criteria describe by Travell and simon)
Participants with GIT symptoms (Heartburn,Flatulence ,Bloating etc)
Participants willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
Participants with History of referred pain and surgery
Participants with spinal degenerative joint disease
Participants with motor vehicle accident ,trauma, fracture
Participants with cardiovascular disorders
Participants with neurological disorders
Participants with endocrinal disorders
Participants with psychological disorders
Uncooperative participants
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
GSRS scale
Tenderness rating scale
Heart rate variability
|
The outcome measures will be assessed at baseline and after 4 weeks.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Blood Pressure
Pulse rate
|
The outcome measures will be assessed at and after 4 week |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
20/03/2025 |
| Date of Study Completion (India) |
01/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
01/07/2025 |
|
Estimated Duration of Trial
|
Years="28"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Manuscript has been prepared and is currently under review by the research supervisor for submission. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
It is a randomized controlled trial double blinded study with a duration of 4 weeks and involving 70 patients that will be divided into two groups by lottery method. Intervention for first group includes Myofascial release and hot pack, intervention for second group (Conventional group) is Neck Isometric exercises, TENS and hot pack. Firstly, the patients will be informed about the study, and informed consent will be taken from them. Before beginning the treatment each patients demographic data including age, gender, weight and height will be gathered as a baseline data. Pre-intervention measurements of outcome variables including Heart rate Variability, Tenderness Rating Scale, Gastrointestinal Symptom Rating Scale, Blood Pressure and Pulse Rate will be taken. Intervention will be given for 4 weeks and then the post-intervention data of all the outcome variables will be taken. Recruitment, intervention, and data collection have been completed. A total of 70 participants were enrolled in the study. Data analysis is complete, and the thesis has been submitted in 1 July 2025. The manuscript has been prepared and is currently under review by the research supervisor prior to submission for publication. |