| CTRI Number |
CTRI/2026/04/108723 [Registered on: 20/04/2026] Trial Registered Prospectively |
| Last Modified On: |
18/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Inspiratory muscle training in Low back pain. |
|
Scientific Title of Study
|
Effect of Inspiratory muscle training on pulmonary functions and pain among individuals with chronic mechanical 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 |
Charvi Grover |
| Designation |
Undergraduate student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room no 1, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar University, Mullana, Ambala, Haryana
Ambala
HARYANA
133203
India |
| Phone |
09468254739 |
| Fax |
|
| Email |
charvigrover1705@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mandeep Kumar Jangra |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room no 5 Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
Ambala
HARYANA
133203
India |
| Phone |
9416797708 |
| Fax |
|
| Email |
mandeep.jangra@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Mandeep Kumar Jangra |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room no 5 Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
Ambala
HARYANA
133203
India |
| Phone |
9416797708 |
| Fax |
|
| Email |
mandeep.jangra@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NOT APPLICABLE |
| Type of Sponsor |
Other [] |
|
|
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 |
| Charvi |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
Room No. 5, Cardiopulmonary Physiotherapy Research Lab, Mullana
Ambala
HARYANA |
09468254739
charvigrover1705@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTE, MAHARISHI MARKANDESHWAR INSTITUTE OF MEDICAL SCIENCE AND RESEARCH, MULLANA, AMBALA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONVENTIONAL PHYSIOTHERAPY MANAGEMENT |
SPINAL EXERCISE, BACK MUSCLE STRETCHING EXERCISES for 6 DAYS A WEEK FOR 4 WEEKS |
| Intervention |
Inspiratory Muscle Training along with conventional physiotherapy management |
Inspiratory Muscle Training will be performed twice a day, 6 days a week for 4 weeks. Inspiratory Muscle Training will be started with 30 inspiratory efforts with 50% MIP and load will be increased incrementally once 30 breaths became easy to complete. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with suffering from mechanical low back pain. |
|
| ExclusionCriteria |
| Details |
individuals who are active smoker, Individuals with spinal deformity, Contagious disease, Neurological disease, specific spinal pathologies, Fractures, infections, tumor of spine, Pregnant female, chronic respiratory disease, recent surgery, rheumatic disease. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
PFT (FEV1, FVC, FEV1/FVC)
Pain (VAS) |
AT BASELINE AND AFTER 4 WEEK OF INTERVENTION |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
30/04/2026 |
| 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="1"
Months="0"
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
|
Chronic mechanical low back pain (CMLBP) is commonly associated with impaired core stability and altered breathing patterns, which may negatively affect pulmonary function and increase pain levels. Inspiratory Muscle Training (IMT) has been proposed as an adjunct intervention to improve respiratory muscle strength and enhance trunk stability. This randomized controlled trial aims to evaluate the effect of IMT on pulmonary functions and pain among individuals with chronic mechanical low back pain. Participants will be randomly allocated into an experimental group receiving IMT along with conventional physiotherapy, and a control group receiving conventional physiotherapy alone. Pulmonary function parameters (such as Forced Vital Capacity and Maximal Inspiratory Pressure) and pain intensity (using Visual Analogue Scale) will be assessed before and after the intervention period. The study is expected to determine whether the addition of IMT leads to significant improvements in pulmonary function and reduction in pain compared to conventional physiotherapy alone, thereby supporting its inclusion in rehabilitation programs for individuals with chronic low back pain. |