| CTRI Number |
CTRI/2025/12/098960 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
13/12/2025 |
| 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
|
Effect of respiratory muscle stretch gymnastics on lung function and hand grip strength in neck pain. |
|
Scientific Title of Study
|
effect of respiratory muscle stretch gymnastics on pulmonary function and hand grip strength in patient of non-specific neck pain. a randomized controlled trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
sundus afza |
| Designation |
student |
| Affiliation |
School of Health Sciences Chhatrapati Shahu Ji Maharaj University Kanpur |
| Address |
School of Health Sciences
Department of Physiotherapy
Chhatrapati Shahu Ji Maharaj University Kanpur Nagar Uttar Pradesh 208024 India
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
7985028831 |
| Fax |
|
| Email |
sundusafza363@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hina Vaish |
| Designation |
Assistant Professor |
| Affiliation |
School of Health SciencesChhatrapati Shahu Ji Maharaj University Kanpur |
| Address |
School of Health Sciences
Department of Physiotherapy
SHS 126 CSJMU Kanpur
Kanpur Nagar Uttar Pradesh 208024 India
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
9450124758 |
| Fax |
|
| Email |
hinavaish@csjmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hina Vaish |
| Designation |
Assistant Professor |
| Affiliation |
School of Health SciencesChhatrapati Shahu Ji Maharaj University Kanpur |
| Address |
School of Health Sciences
Department of Physiotherapy
SHS 126 CSJMU Kanpur
Kanpur Nagar Uttar Pradesh 208024 India
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
9450124758 |
| Fax |
|
| Email |
hinavaish@csjmu.ac.in |
|
|
Source of Monetary or Material Support
|
| School of Health Sciences Department of Physiotherapy SHS 126 CSJMU Kanpur Kanpur Nagar UTTAR PRADESH 208024 India |
|
|
Primary Sponsor
|
| Name |
School of Health Sciences Chhatrapati Shahuji Maharaj University |
| Address |
School of Health Sciences Department of Physiotherapy SHS 126 CSJMU Kanpur Kanpur Nagar Uttar Pradesh 208024 India |
| 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 Hina Vaish |
School of Health Sciences Physiotherapy OPD |
School of Health Sciences
Department of Physiotherapy Physiotherapy OPD SHS 126
Chhatrapati Shahu Ji Maharaj University Kanpur Nagar Uttar Pradesh 208024 India
Kanpur Nagar
UTTAR PRADESH |
9450124758
hinavaish@csjmu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Ethical Committee Chhatrapati Shahuji Maharaj University Kanpur India |
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 therapy |
TENS for 10 mins and 2 sets with 8-12 repetitions of 5 strengthening exercises are given for 4 weeks to controlled group. |
| Intervention |
respiratory muscle stretch gymnastics TENS and exercises |
all 5 steps of 2 sets respiratory muscle stretch gymnastics TENS and exercises for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Non-specific neck pain patients
Pain persistent for 3 months
Pain rating more than 3 on NPRS |
|
| ExclusionCriteria |
| Details |
Spinal surgery
Smokers
Pregnancy
radiculopathy
diabetes
injury
malignancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pulmonary function
Hand grip strength |
pre and post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain intensity (NPRS).
Neck disability (NDI).
|
pre and post intervention |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
28/12/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The research proposes a randomized controlled trial with sample size 36 with non-specific neck pain being recruited and randomly assigned to experimental or control groups using block randomization. The study is open-label with 1:1 allocation. After informed consent, baseline data including BMI, pain (NPRS), PFT , and neck disability (NDI) will be recorded. Both receive conventional therapy (TENS and exercises), while the experimental group also performs RMSG exercise. RMSG includes 5 patterns, which typically involve diaphragmatic breathing, chest expansion movements, and coordinated postural exercises performed in a structured sequence. TENS is applied to all the participants’ neck areas for 10 minutes, 5 days a week over 4 weeks .The control group receives only this conventional therapy. Post-intervention assessments will compare changes in all outcomes between groups. |