CTRI Number |
CTRI/2025/06/089636 [Registered on: 26/06/2025] Trial Registered Prospectively |
Last Modified On: |
25/06/2025 |
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
|
Diaphragmatic Breathing and Core Stability for Desk Worker having Chronic Non specific Low Back Pain and function |
Scientific Title of Study
|
Effect of diaphragmatic breathing exercises and core stabilization exercises on pain function and core strength in desktop
workers with chronic non-specific low back pain A randomised 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 |
Dr Smita Shinde |
Designation |
Associate professor |
Affiliation |
Dr D Y Patil college of physiotherapy pune |
Address |
Dr D Y Patil college of physiotherapy Sant Tukaram Nagar Pimpri Pune
Pune MAHARASHTRA 411018 India |
Phone |
9028151551 |
Fax |
|
Email |
smita.shinde@dpu.edu.in |
|
Details of Contact Person Scientific Query
|
Name |
Dr Smita Shinde |
Designation |
Associate professor |
Affiliation |
Dr D Y Patil college of physiotherapy pune |
Address |
Dr D Y Patil college of physiotherapy Sant Tukaram Nagar Pimpri Pune
Pune MAHARASHTRA 411018 India |
Phone |
9028151551 |
Fax |
|
Email |
smita.shinde@dpu.edu.in |
|
Details of Contact Person Public Query
|
Name |
Simran kukreja |
Designation |
Post Graduate student |
Affiliation |
Dr D Y Patil college of physiotherapy Sant Tukaram Nagar Pimpri Pune |
Address |
Dr D Y Patil college of physiotherapy Sant Tukaram Nagar Pimpri Pune Dr D Y Patil college of physiotherapy Sant Tukaram Nagar Pimpri Pune Pune MAHARASHTRA 411018 India |
Phone |
9168112292 |
Fax |
|
Email |
kukrejasimran92@gmail.com |
|
Source of Monetary or Material Support
|
DR DY Patil College of Physiotherapy Sant Tukaram Nagar Pimpri Pune 411018 |
|
Primary Sponsor
|
Name |
Dr D Y Patil college of physiotherapy |
Address |
DR DY Patil College of Physiotherapy Sant tukaram nagar pimpri pune 411018 |
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 Simran Kukreja |
Dr D.Y. Patil College of Physiotherapy |
Dr D.Y. Patil College of Physiotherapy Sant Tukaram Nagar Pimpri Chinchwad Pune Maharashtra 411018 Pune MAHARASHTRA |
09168112292
kukrejasimran92@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
institutional ethics committe of Dr D Y Patil College of Physiotherapy Pune |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Desktop Workers with Chronic non specific low back pain |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Core stabilization exercises |
The exercise program includes a series of movements targeting spinal mobility and core strengthening. Single Knee to Chest and Double Knee to Chest help improve spinal flexibility and reduce lower back stiffness. Prone Lying with One Leg Sliding strengthens the back extensors and enhances lumbar control. Crook Lying with Crunches activates the rectus abdominis and obliques to improve core stability. Supine Leg Lifts focus on strengthening the lower abdominal muscles and supporting the lumbar spine. Bridging Exercise strengthens the glutes and back muscles to improve pelvic and lumbar stability. Finally, Cycling in Supine enhances coordination and strengthens the abdominal muscles. |
Intervention |
Diaphragmatic Breathing exercises and Core stabilization exercises |
A structured 4-week progression of Abdominal Drawing-In Maneuver (ADIM) exercises. In Week 1, Prone ADIM (lying on the stomach) and Seated ADIM (in a chair with one arm raised), focusing on activating the Transversus Abdominis in low-effort positions and improving postural control. Week 2 Supine ADIM with heel slides in a crook-lying position and Quadruped ADIM with alternating leg lifts, aiming to enhance pelvic control and trunk stability. In Week 3, Bridging with ADIM to strengthen glutes and the lower back while maintaining core activation, and Swiss Ball ADIM to challenge balance and abdominal muscle control. Week 4 advanced to Squats with ADIM, promoting lower limb strength and stability, and Standing ADIM with arm and leg movements, incorporating dynamic balance, coordination, and proprioceptive training while maintaining core engagement.Throughout the intervention, diaphragmatic breathing will also be incorporated to promote deep core activation and support proper breathing patterns alongside abdominal control. |
|
Inclusion Criteria
|
Age From |
23.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1)Pain in the low back on most days for at least 3 months and at least half of the days in the past 6 months.
2)Pain severity of mild to moderate on the Visual Analog Scale (VAS) ranging from (3 to less than or equal to 7)
3)Both Males and Females between 23 - 60 years.
4)Pain restricted to the low back.
5) Absence of neurological symptoms or deficit (eg, spontaneous paresthesias or motor deficit localizing to a nerve root distribution) or symptoms in the lower extremities (eg, spontaneous paresthesias).
|
|
ExclusionCriteria |
Details |
1)Diagnosed specific causes of low back pain.
2)Respiratory diseases
3)Recent trauma to the lumbopelvic, abdominal, or thoracic regions.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1)Visual Analog Scale(VAS)
2)Roland–Morris Disability Questionnaire
3)Pressure Biofeedback Unit (PBU) |
1)Visual Analog Scale(VAS)
2)Roland–Morris Disability Questionnaire
at Day 0 and after 4 weeks
3)Pressure Biofeedback Unit (PBU) |
|
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)
|
10/07/2025 |
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
|
Effect of Diaphragmatic Breathing Exercises and Core Stabilization Exercises on Pain, Function, and Core Strength in Desktop Workers with Chronic Non-Specific Low Back Pain: A Randomised Controlled Trial This randomized controlled trial aims to evaluate the effect of diaphragmatic breathing exercises combined with core stabilization exercises on pain, function, and core strength in individuals suffering from chronic non-specific low back pain (CNSLBP), particularly those engaged in prolonged sitting due to desk-based occupations. A total of 60 participants will be recruited and randomly assigned into intervention and control groups. The study will be conducted over a period of four weeks, with supervised sessions three times per week. The outcomes will be assessed using the Visual Analog Scale (VAS), Roland-Morris Disability Questionnaire (RMDQ), and Pressure Biofeedback Unit (PBU). |