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CTRI Number  CTRI/2025/03/082921 [Registered on: 20/03/2025] Trial Registered Prospectively
Last Modified On: 18/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Effect Of Hypopressive Abdominal Gymnastics On Pain, Flexibility And Function In Individuals With Non Specific Low Back Pain  
Scientific Title of Study   Effect Of Hypopressive Abdominal Gymnastics On Pain, Flexibility And Function In Individuals With Non-Specific 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  Samridhi 
Designation  Post Graduate Student 
Affiliation  Ahmedabad Institute Of Medical Sciences 
Address  Room no 1 Division Exercise Therapy Department Physiotherapy Ahmedabad Institute Of Medical Sciences Nr S P Ring Road Ognaj Circle Gota Kalol Highway Lapkaman Ahmedabad

Ahmadabad
GUJARAT
380060
India 
Phone  7600618419  
Fax    
Email  samridhi2102@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kairavi Trivedi 
Designation  Lecturer, PG Guide 
Affiliation  Ahmedabad Institute Of Medical Sciences 
Address  Room no 1 Division Exercise Therapy Department Physiotherapy Ahmedabad Institute Of Medical Sciences Nr S P Ring Road Ognaj Circle Gota Kalol Highway Lapkaman Ahmedabad

Ahmadabad
GUJARAT
380060
India 
Phone  9428638232  
Fax    
Email  kairavitrivedi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kairavi Trivedi 
Designation  Lecturer, PG Guide 
Affiliation  Ahmedabad Institute Of Medical Sciences 
Address  Room no 1 Division Exercise Therapy Department Physiotherapy Ahmedabad Institute Of Medical Sciences Nr S P Ring Road Ognaj Circle Gota Kalol Highway Lapkaman Ahmedabad

Ahmadabad
GUJARAT
380060
India 
Phone  9428638232  
Fax    
Email  kairavitrivedi@gmail.com  
 
Source of Monetary or Material Support  
Ahmedabad Institute Of Medical Sciences Nr S P Ring Road Ognaj Circle Gota Kalol Highway Lapkaman Ahmedabad Gujarat India 380060 
 
Primary Sponsor  
Name  Ahmedabad Institute Of Medical Sciences 
Address  Room no 1 Division Exercise Therapy Department Physiotherapy Ahmedabad Institute Of Medical Sciences Nr S P Ring Road Ognaj Circle Gota Kalol Highway Lapkaman Ahmedabad Gujarat India 380060 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kairavi Trivedi  Ahmedabad Institute Of Medical Sciences  Room no 1 Division Exercise Therapy Department Physiotherapy Ahmedabad Institute Of Medical Sciences Nr S P Ring Road Ognaj Circle Gota Kalol Highway Lapkaman Ahmedabad Gujarat India 380060
Ahmadabad
GUJARAT 
9428638232

kairavitrivedi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Research And Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  With Non-Specific Low Back Pain 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Low Back Pain Therapy  Pelvic bridging Pelvic tilt Back extension Static abdominal Knee to chest Lion exercises Curl ups Cat and camel and hamstring stretchching followed by hot pack for 10 mins 8 sessions for 2 weeks on low back each session for 20-25 minutes 
Intervention  Hypopressive Abdominal Gymnastics   8 sessions for 2 weeks on low back each session for 20-25 minutes and conventional therapy with hot pack for 10 mins 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Individuals diagnosed with non-specific low back pain persistent for more than a week
Visual Analog Scale (VAS) score ranging between 3-7
 
 
ExclusionCriteria 
Details  Patients with cardio-respiratory disease
Pregnancy or suspected pregnancy
Patients with disc lesion or stenosis
Patients with spinal deformities
Patients with spondylolysis or spondylolisthesis
Neuromuscular conditions or rheumatisms 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Visual Analog Scale (VAS)  Before treatment at baseline and after 2 weeks of treatment
On activity and at rest 
 
Secondary Outcome  
Outcome  TimePoints 
Flexibility using Sit And Reach Test  Before treatment at baseline and after 2 weeks of treatment
 
Modified Oswestry Disability Index  Before treatment at baseline and after 2 weeks of treatment
 
 
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)   15/03/2026 
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 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  

INTRODUCTION

q   Low back pain is a highly prevalent issue with a widespread distribution.

q  It is an omnipresent and often debilitating condition that affects a significant portion of the global population.

q  It is one of the preeminent cause for disability and notably impacts productivity, affecting individuals and healthcare systems worldwide.

q  The majority of low back pain cases are considered non-specific, indicating they lack a clear identifiable pathological cause.

q  Non-specific low back pain includes various pain sensations that cannot be linked to obvious structural issues like fractures, herniated discs, or infections.

q  This wide classification of non-specific low back pain encompasses pain from muscle strain, sprains, bad posture, or overuse, often worsened by psychological factors like stress and anxiety.

q  A research in 2022 found that 66% of the population in India had experienced low back pain at some point in their lifetime.

q  In 1980, Caufriez et al. introduced Hypopressive Abdominal Gymnastics (HAG) to prevent pelvic floor issues post-pregnancy, and later to enhance postural stability.

q  The focus is on exercises for posture that help reduce pressure in the abdominal, perineal, and thoracic cavities.

q  This technique, combined with posture methods, targets activating type I tonic muscle fibers, which should enhance the coordinated activation of all muscles involved in posture, including the deep muscles in the trunk.

q  These exercises could directly engage the transversus abdominis muscle, potentially enhancing the strength of the abdominal wall and better spine stabilization.

q  In terms of postural techniques, HAG involves moving through a series of positions, starting with standing and finishing in a supine position, including kneeling, quadruped, and sitting positions along the way.

      NEED OF STUDY

q   Low back pain is the leading cause of disability in terms of years lived with disability (YLDs). 

q  So it is essential to integrate innovative methods to accomplish accelerated recovery in individuals with LBP, thus enhancing patient outcomes.

q  Up until now, most studies have concentrated on evaluating the impacts of HAG on pelvic floor dysfunctions. However, there have been few studies that have examined how core muscle groups may assist in stabilizing the spine properly.

q  Henceforth, training the core muscles which generate trunk stability can be beneficial in alleviating low back pain.

q  There are lack of studies assessing the effects of HAG on non-specific low back pain.

q  Therefore, gaining a deeper understanding of the impacts of HAG is essential in order to begin enhancing and refining various intervention guidelines and protocols.

AIM

Ø  To assess the effect of hypopressive abdominal gymnastics on pain, flexibility and function in individuals with non-specific low back pain.

       OBJECTIVES

q To determine the effect of Hypopressive Abdominal Gymnastics (HAG) on pain by VAS in individuals with non-specific low back pain.

q  To determine the effect of Hypopressive Abdominal Gymnastics (HAG) on flexibility by Sit and Reach test in individuals with non-specific low back pain.

q  To determine the effect of Hypopressive Abdominal Gymnastics (HAG) on function by Modified Oswestry Disability Index (MODI) in individuals with non-specific low back pain.

     HYPOTHESIS

Null Hypothesis

q H01 : There is no significant effect of Hypopressive Abdominal Gymnastics (HAG) on pain in individuals with non-specific low back pain.

q  H02 : There is no significant effect of Hypopressive Abdominal Gymnastics (HAG) on flexibility in individuals with non-specific low back pain.

q  H03 : There is no significant effect of Hypopressive Abdominal Gymnastics (HAG) on function in individuals with non-specific low back pain.

q  H04 : There is no significant effect of Conventional Therapy on pain in individuals with non-specific low back pain.

q  H05 : There is no significant effect of Conventional Therapy on flexibility in individuals with non-specific low back pain.

q H06 : There is no significant effect of Conventional Therapy on function in individuals with non-specific low back pain.

q H07 : There is no significant difference between Hypopressive Abdominal Gymnastics (HAG) and Conventional Therapy on pain in individuals with non-specific low back pain.

q  H08 : There is no significant difference between Hypopressive Abdominal Gymnastics (HAG) and Conventional Therapy on flexibility in individuals with non-specific low back pain.

q  H09 : There is no significant difference between Hypopressive Abdominal Gymnastics (HAG) and Conventional Therapy on function in individuals with non-specific low back pain.

Alternate Hypothesis

q H11 : There is significant effect of Hypopressive Abdominal Gymnastics (HAG) on pain in individuals with non-specific low back pain.

q  H12 : There is significant effect of Hypopressive Abdominal Gymnastics (HAG) on flexibility in individuals with non-specific low back pain.

q  H13 : There is significant effect of Hypopressive Abdominal Gymnastics (HAG) on function in individuals with non-specific low back pain.

q  H14 : There is significant effect of Conventional Therapy on pain in individuals with non-specific low back pain.

q  H15 : There is significant effect of Conventional Therapy on flexibility in individuals with non-specific low back pain.

q  H16 : There is significant effect of Conventional Therapy on function in individuals with non-specific low back pain.

q H17 : There is significant difference between Hypopressive Abdominal Gymnastics (HAG) and Conventional Therapy on pain in individuals with non-specific low back pain.

q  H18 : There is significant difference between Hypopressive Abdominal Gymnastics (HAG) and Conventional Therapy on flexibility in individuals with non-specific low back pain.

q  H19 : There is significant difference between Hypopressive Abdominal Gymnastics (HAG) and Conventional Therapy on function in individuals with non-specific low back pain.

      METHODOLOGY

Ø  Study Design :- An Experimental Study (NRCT)

Ø  Study Duration :- 6 months

Ø  Sample Size :- 36 (18 in each group)

Ø  Sample Design :- Simple random sampling

Ø  Group A :- Hypopressive Abdominal Gymnastics + Conventional Therapy

Ø  Group B :- Conventional Therapy

Ø  Treatment Duration :- 2 weeks

OUTCOME MEASURES

q Pain using Visual Analog Scale (VAS).

q  Flexibility using Sit and Reach Test.

q  Function using Modified Oswestry Disability Index (MODI).

     CRITERIA

INCLUSION

        Individuals between the age of 18-40 years (According to Newman’s Classification)

        Males and females both

        Individuals diagnosed with non-specific low back pain persistent for more than a week

        Visual Analog Scale (VAS) score ranging between 3-7

        Individuals diagnosed with non-specific low back pain willing to participate

EXCLUSION

        Patients with cardio-respiratory disease

        Pregnancy or suspected pregnancy

        Patients with disc lesion or stenosis

        Patients with spinal deformities

        Patients with spondylolysis or spondylolisthesis

        Neuromuscular conditions or rheumatisms

 MATERIALS TO BE USED

Ø  Consent form

Ø   A box about 30 cms or a step

Ø   Ruler

Ø   Plinth or mat

Ø   Hot pack

Ø   Stopwatch

Ø   Paper

Ø   Pen

Ø   Pencil

Ø   Visual Analog Scale (VAS)

Ø   Modified Oswestry Disability Index (MODI)

      PROCEDURE

q Ethical clearance from the Institutional Ethics and Research Committee will be taken.

q  After ethical approval the subjects will be screened as per the eligibility of inclusion criteria.

q  Subjects will be explained about the study.

q  A written consent form will be signed by the subjects.

q  The subjects will be divided in two groups.

q  Pre assessment will be taken for pain, flexibility and function.

q  Group A [Experimental group] will receive Hypopressive Abdominal Gymnastics along with Conventional Therapy

q Group B [Control Group] will receive Conventional Therapy.

q  After 2 weeks of treatment, post assessment will be taken.

In group A (experimental group), administer Hypopressive Abdominal Gymnastics along with Conventional Therapy

q Patient position :- Begin with standing

q Procedure :- Hypopressive Abdominal Gymnastics will be carried out based on the principles established by Curifez, Rebullido and Pinsach.(4)

q They detailed the following steps :-

        Neutral pelvis as well as spine elongation

        Dorsiflexion of ankles

        Flexion of knees

        Shoulder girdle muscle activation

q Now, they will perform 3 normal breathing cycles with slow deep exhalations (inspiration and maximum exhalation).

q  Followed by “diaphragmatic aspiration” maneuver, i.e. breathing maintenance after expansion of rib cage.

q Treatment duration :- 2 weeks, 8 sessions (4 sessions per week)

q Every session includes 6 hypopressive abdominal gymnastics with 2 minutes of rest between each, and each exercise will be done 3 times. 

q In group B (control group), Conventional Therapy will be administered.

q Patient position :- Supine lying

q Procedure :- The following protocol is to be followed(19) :-

        Hot pack application :- 10 minutes

        Pelvic bridging

        Pelvic tilt exercises

        Back extension exercises

        Static abdominal exercises

        Knee to chest exercises

        Curl-ups

        Lion exercises

        Cat-camel stretch

        Static Hamstring stretches :- 30 seconds hold, 3 repetitions(20)

        Treatment duration :- 2 weeks, 8 sessions (4 sessions per week)

        Each exercise will have 10 repetitions and one set will be performed.

 STATISTICAL ANALYSIS

Ø  Suitable statistical tests depending upon the distribution of data would be applied.


 
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