| CTRI Number |
CTRI/2025/05/086937 [Registered on: 14/05/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| 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
|
How Kinesio Taping and a Special Breathing Exercise Called Crocodile Breathing Affect Breathing Muscles in People with Long-Term Lower Back Pain
|
|
Scientific Title of Study
|
Effect of ktaping and crocodile breathing exercise on respiratory muscle in patient with chronic Non-specific low back 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 |
Sakshi Gupta |
| Designation |
PostGraduate |
| Affiliation |
Dr. D.Y. Patil College of Physiotherapy |
| Address |
A-40,4th floor, Carnation old girls hostel Dr DY Patil Vidyapeeth sant Tukaram nagar Pimpri Pune
190, Dr DY Patil College Rd, Sant Tukaram Nagar, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9284966033 |
| Fax |
|
| Email |
024sakshigupta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mayura P Deshmukh |
| Designation |
PhD |
| Affiliation |
Dr. D.Y. Patil College of Physiotherapy |
| Address |
310, Department of Cardiorespiratory Physoitherapy, Dr. D Y Patil Colllege of Physiotherapy,Dr. D Y Patil Vidyapeeth, Sant Tukaram Nagar, Pimpri-Chinchwad, Maharashtra
Pune
MAHARASHTRA
411018
India |
| Phone |
8149376929 |
| Fax |
|
| Email |
mayuradeshmukh04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mayura P Deshmukh |
| Designation |
PhD |
| Affiliation |
Dr. D.Y. Patil College of Physiotherapy |
| Address |
310, Department of Cardiorespiratory Physoitherapy, Dr. D Y Patil Colllege of Physiotherapy,Dr. D Y Patil Vidyapeeth, Sant Tukaram Nagar, Pimpri-Chinchwad, Maharashtra
Pune
MAHARASHTRA
411018
India |
| Phone |
8149376929 |
| Fax |
|
| Email |
mayuradeshmukh04@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D Y Patil Colllege of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
Sakshi Gupta |
| Address |
310, Department of Cardiorespiratory Physoitherapy, Dr. D Y Patil Colllege of Physiotherapy,Dr. D Y Patil Vidyapeeth, Sant Tukaram Nagar, Pimpri-Chinchwad, Maharashtra |
| Type of Sponsor |
Other [Self] |
|
|
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 Mayura Deshmukh |
Dr DY Patil College of Physiotherapy |
310, Department of Cardiorespiratory Physoitherapy, Dr. D Y Patil Colllege of Physiotherapy,Dr. D Y Patil Vidyapeeth, Sant Tukaram Nagar, Pimpri-Chinchwad, Maharashtra
Pune
MAHARASHTRA |
8149376929
mayuradeshmukh04@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M709||Unspecified soft tissue disorder related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional treatment |
conventional treatment
Interferential Therapy (IFT) at 4000 Hz with 80 Hz AMF for 20 minutes, spinal-based exercises (bridging, posterior pelvic tilt, core strengthening, 15–20 reps)
|
| Intervention |
ktaping & crocodile breathing exercise |
Participants will undergo a 4-week intervention including Interferential Therapy (IFT) at 4000 Hz with 80 Hz AMF for 20 minutes, spinal-based exercises (bridging, posterior pelvic tilt, core strengthening, 15–20 reps), crocodile breathing (10 min daily), and Kinesio taping to the diaphragm (reapplied weekly). Sessions will be conducted daily at a consistent time. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Non-specific low back pain patients
2)Male and female age 20–50-year-old
3) Patient with VAS score of 4 or higher
|
|
| ExclusionCriteria |
| Details |
1)elderly population above 50
2)back pain severe and require surgery
3)patient having difficulty performing breathing exercise
4)unwilling to participate
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Pain – VISUAL ANALOG SCALE
2)Diaphragmatic function – respiratory meter PiMax pMax through RPM device
|
week 0 and week 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Functional assessment – ROLAND MORRIS DISABILITY INDEX
|
week 0 & week 4 |
|
|
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
15/06/2025 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
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
Modification(s)
|
Low back pain (LBP) is a common condition affecting up to 84% of people, often leading to disability, reduced quality of life, and high healthcare costs. Most cases are nonspecific, with no clear cause, and often result from spinal instability. The diaphragm, which attaches to the lumbar spine, plays a key role in stabilizing the spine through intra-abdominal pressure. In people with LBP, diaphragm function is often impaired, leading to poor posture and increased pain. Breathing exercises like crocodile breathing and kinesio taping can help improve diaphragm activation, posture, and reduce pain.
The aim of this study is to evaluate the effect of K-Taping and crocodile breathing exercises on respiratory muscle strength in patients with chronic non-specific low back pain. The objectives include assessing the impact of Interferential Therapy (IFT) and spinal-based exercises on pain, respiratory muscle strength, and quality of life in these patients. Additionally, the study seeks to determine the combined effect of K-Taping and crocodile breathing exercises when integrated with IFT and spinal-based exercises. Finally, it aims to compare the outcomes between patients receiving only IFT and spinal-based exercises and those receiving the combination of IFT, spinal-based exercises, K-Taping, and crocodile breathing exercises.
METHODOLOGY STUDY DESIGN : Experimental study design STUDY SETTING : DR. D.Y. PATIL COLLEGE OF PHYSIOTHERAPY, PUNE TARGET POPULATION : patient coming to OPD SAMPLE POPULATION : patient with Chronic Non-specific low back pain SAMPLING METHOD : convenient sampling SAMPLE SIZE : 60 (Calculated by statistician) SAMPLE DESIGN : experimental study design
The study will be conducted at Dr. D.Y. Patil College of Physiotherapy, Pimpri, Pune, following approval from the academic committee. Participants will be selected based on inclusion and exclusion criteria, and informed written consent will be obtained. The procedure and interventions will be explained in detail, with time allotted for any questions. Pre-assessments will be conducted with the participant seated. Kinesio taping will be applied to the diaphragm while the participant is standing in a breath-out position. Interventions, including crocodile breathing exercises and spinal-based exercises, will be performed on a plinth. Interferential Therapy (IFT) will be administered using a carrier frequency of 4000 Hz, with amplitude modulation of 80 Hz, for 20 minutes. Spinal-based exercises will include bridging, posterior pelvic tilt, and strengthening exercises for back and abdominal muscles, performed in 15–20 repetitions. K-Taping will be applied to the diaphragm and replaced weekly. Crocodile breathing will be practiced for 10 minutes daily. The entire protocol will continue for four weeks, with sessions scheduled at approximately the same time each day for consistency. |