| CTRI Number |
CTRI/2026/02/102976 [Registered on: 04/02/2026] Trial Registered Prospectively |
| Last Modified On: |
04/02/2026 |
| 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 breathing exercises on improving balance and trunk muscle function in people with low back pain. |
|
Scientific Title of Study
|
Effect of Inspiratory Muscle Training on Core Muscle Activity and Postural Stability in Individuals with Low Back 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 |
Mehak Kapila |
| Designation |
Post graduate student |
| Affiliation |
ISIC-Institute off Rehabilitation Sciences. |
| Address |
ISIC-Institute of Rehabilitation Sciences, IAA Colony, Sector C Vasant Kunj
South
DELHI
110070
India |
| Phone |
9953259029 |
| Fax |
|
| Email |
mehakapila16@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rimsha Siddiqui |
| Designation |
Sr. Manager Operations (PMR) & Assistant Professor, ISIC-Institute of Rehabilitation Sciences. |
| Affiliation |
Indian Spinal Injuries Center |
| Address |
ISIC-Institute of Rehabilitation Sciences, IAA Colony, Sector C, Vasant Kunj
South West
DELHI
110070
India |
| Phone |
9911288516 |
| Fax |
|
| Email |
rimshasiddiqui46@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rimsha Siddiqui |
| Designation |
Sr. Manager Operations (PMR) & Assistant Professor, ISIC-Institute of Rehabilitation Sciences. |
| Affiliation |
Indian Spinal Injuries Center |
| Address |
ISIC-Institute of Rehabilitation Sciences, IAA Colony, Sector C, Vasant Kunj
South West
DELHI
110070
India |
| Phone |
9911288516 |
| Fax |
|
| Email |
rimshasiddiqui46@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Spinal Injuries Centre, Sector C, Vasant Kunj, New Delhi - 110070, India |
|
|
Primary Sponsor
|
| Name |
Indian Spinal Injuries Centre |
| Address |
IAA Colony, Sector C, Vasant Kunj, New Delhi - 110070 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rimsha Siddiqui |
Indian Spinal Injuries Centre |
PMR department, ISIC-Institute of Rehabilitation Sciences, IAA Colony, Sector C, Vasant Kunj, New Delhi-110070
South West
DELHI |
9911288516
rimshasiddiqui46@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indian Spinal Injuries Centre Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individuals with Low Back Pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Low Back Pain Exercises |
Participants will receive conventional Low Back Pain exercises consisting of standard Core Stabilization, Strengthening and low back pain exercises.
Along with this Participant will receive sham (at minimal resistance insufficient to produce a training effect) Inspiratory Muscle Training for 4 weeks. |
| Intervention |
Inspiratory Muscle Training with Conventional Low Back Pain |
Participants will receive Inspiratory Muscle Training using a Philips Respironics Treshold Inspiratory Muscle Training device along with the standard core stabilization and Low Back pain exercises for a period of 4 weeks.
Inspiratory Muscle Training will be performed at an intensity based on a percentage of Maximal Inspiratory pressure, with progressive loading. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
At least 3 Episodes of non-specific Low Back Pain in past 4 weeks.
Score of atleast 10 percent on Oswestry Disability Index.
Numerical Pain Rating Scale of less than equal to 5.
B.M.I less than 30.
|
|
| ExclusionCriteria |
| Details |
Recent Spinal Surgeries (in 1 yr.)
Any known/diagnosed neurological/cardiovascular/balance problems (e.g., vestibular or neurological disorder).
Any recent (in 1 yr.) specific reason for Low Back Pain (e.g., Spondylolisthesis)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Postural Stability- assessed by center of pressure displacement using force plate analysis.
Core Muscle Activity - assessed by Electromyography (EMG) of Rectus abdominis, Transverse Abdominis, Multifidus and Erector Spinae muscles. |
4 weeks post Intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Inspiratory muscle strength - using maximal inspiratory pressure measurement by spirometry.
Pain Intensity - using Numerical Pain Rating Scale.
Functional Disability - Oswestry Disability Index |
4 weeks 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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
17/02/2026 |
| 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
|
Low Back Pain is a common musculoskeletal condition that is often associated with impaired Core Muscle function and reduced postural stability. Inspiratory muscle training has been shown to influence trunk muscle activation and spinal stability through its effect on the diaphragm and core musculature. The purpose of this study is to evaluate the effect of inspiratory muscle training in addition to conventional low back pain exercises on core muscle activity and postural stability in individuals with non-specific low back pain. A total of 36 individuals with non-specific low back pain aged 20 to 40 will be randomly allocated into 2 groups. The experimental group will receive Inspiratory muscle training along with conventional low back pain exercises, while the control group will receive sham inspiratory muscle training along with conventional low back pain exercises. Outcome measures include postural stability will be assessed using center of pressure displacement and core muscle activity will be assessed using electromyography. Inspiratory muscle strength, pain intensity and functional disability will also be evaluated. The outcome assessor will be blinded to group allocation. Descriptive and exploratory statistical analyses will be performed to compare both groups.
|