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CTRI Number  CTRI/2025/02/079837 [Registered on: 03/02/2025] Trial Registered Prospectively
Last Modified On: 20/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   To check the Effect of osteopathic visceral manipulation with shakers exercise in patients with gastroesophageal reflux.  
Scientific Title of Study   Effect of osteopathic visceral manipulation with shakers exercise in patients with gastroesophageal reflux: 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  Aparna kabbe 
Designation  PG Student 
Affiliation  KLE Institute Of Physiotherapy. 
Address  KAHER Institute Of Physiotherapy, Nehru nagar, Belagavi
KAHER Institute Of Physiotherapy, Nehru nagar, Belagavi
Belgaum
KARNATAKA
590010
India 
Phone  9845331809  
Fax    
Email  kabbeaparna@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Anand Heggannavar 
Designation  Head of the department and Professor 
Affiliation  KLE Institute Of Physiotherapy. 
Address  KAHER Institute of Physiotherapy, Orthopedic Manual Therapy Department, JNMC Campus, Nehru Nagar, Belagum Belgaum Karnataka 590010 India

Belgaum
KARNATAKA
10
India 
Phone  994528296  
Fax    
Email  anandheggannavar@klekipt.edu.in  
 
Details of Contact Person
Public Query
 
Name  Anand Heggannavar 
Designation  Head of the department and Professor 
Affiliation  KLE Institute Of Physiotherapy. 
Address  KAHER Institute of Physiotherapy, Orthopedic Manual Therapy Department, JNMC Campus, Nehru Nagar, Belagum Belgaum Karnataka 590010 India

Belgaum
KARNATAKA
10
India 
Phone  994528296  
Fax    
Email  anandheggannavar@klekipt.edu.in  
 
Source of Monetary or Material Support  
KAHER Institute of Physiotherapy Nehru Nagar, Belagavi - 590010 Karnataka 
 
Primary Sponsor  
Name  Kle Academy of Higher Education and Research 
Address  KAHER Institute of Physiotherapy, Belagavi - 590010, Karnataka 
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 Aparna kabbe  KLES Prabhakar Kores Hospital  Sagar Ward, opd no 39, physiotherapy department belgaum karnataka
Belgaum
KARNATAKA 
9845331809

kabbeaparna@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KLE Academy of higher education and Reserach  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K929||Disease of digestive system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Osteopathic Visceral Manipulation and shakers exercise  Osteopathic visceral manipulation will be given only 2 sessions per week for 2 weeks followed by shakers exercise. 
Intervention  Shakers exercise  Shakers exercise will be given a total of 5 sessions per week over 2 week period 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Participants who are willing to participate
Referred cases from Gastroenterologists

 
 
ExclusionCriteria 
Details  Participants not willing to participate
Previous or present gastric cancer
Lack of cognition or comprehend commands  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The GERDQ questionnaire  At baseline and post 2 weeks of treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Frequency scale for gerd symptoms   At baseline post 2 weeks of treatment 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/02/2025 
Date of Study Completion (India) 20/02/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 20/02/2025 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
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)  
Effect of Osteopathic Visceral Manipulation with Shakers exercise in patients with Gastroesophageal Reflux:  A Randomized controlled trial

AIM : To determine The Effect of Osteopathic Visceral Manipulation with Shakers exercise in patients with Gastroesophageal Reflux.

Objectives of the study

To evaluate and compare the effect of Osteopathic Visceral Treatment with Shakers exercise in patients with Gastroesophageal Reflux using The GerdQ questionnaire a  Frequency Scale for Symptoms of GERD (FSSG) and Carlsson dent questionnaire(CDC).

HYPOTHESIS

NULL HYPOTHESIS:

There will be no difference in the effect of Osteopathic Visceral Manipulation with Shakers exercise in patients with Gastroesophageal Reflux.

ALTERNATE HYPOTHESIS:

 There will be difference in the effect of Osteopathic Visceral Manipulation with Shakers exercise in patients with Gastroesophageal Reflux.

Inclusion  Criteria:

1.      Participants who are willing to participate.

2.      Referred cases from Gastroenterologist

3.       Both male and female subjects aged 18-60 years

 

 

 

 

       Exclusion  Criteria:

4.       Past history of any pharyngeal surgery procedures

5.      Lack of cognition or comprehend commands

6.      Previous or present gastric cancer

Inclusion  Criteria:

1.      Participants who are willing to participate.

2.      Referred cases from Gastroenterologist

3.       Both male and female subjects aged 18-60 years

OUTCOME MEASURES:

Frequency Scale for Symptoms of GERD (FSSG).

The GerdQ questionnaire.

PROCEDURE

Ethical clearance will be obtained from the Institutional Ethical Committee

Participants will be selected according to the Inclusion and Exclusion criteria.

The purpose and procedure of the study will be explained to the participant.

An informed consent will be obtained from them.

The purpose and the detailed of the study will be explained to the participants

Participants will be randomly assigned into Group A and Group B by chit   method.

Group A will be given shakers exercise.

Group B will be given  Osteopathic Visceral Treatment and shakers exercise.

Group A will be given of a total of 5 sessions per week over two week period.

Group B will be given  only two sessions, per week followed by shakers exercise for two week period.

Group A

      Shaker’s Exercise: the exercises are performed in two parts viz. Isometric hold contractions followed by isokinetic repeated contractions.

       Initially subjects performed sustained head lifts for the 1-min in the supine position with a 1- minute rest between lifts for 3 consecutive repetitions.

       This was then progressed by participants’ tolerance to 30 consecutive repetitions of head raisings in supine position. For both sustained and repetitive head rising, volunteers were instructed to raise the head high enough to be able to observe their toes without raising their shoulders.

       Participants were instructed to stop the exercises right away if the they start to feel light headed, become short of breath or get a headache.

       They were also instructed not to hold breath with isometric holds.

       Participants were advised neck stretching exercises to help ease the soreness.

 

Group B

      Visceral osteopathic technique along with shakers exercises which is commonly used for GERD.

      To perform the technique, the patient will be in seating, and the osteopath stayed behind, with the osteopath´s hands placed in the patient´s epigastric area.

      The patient was then asked to bend in flexion while breathing in, so the osteopath deepened her hands on the patient´s epigastrium.

       After that, the patient was asked to straighten his whole spine and to extend his neck while breathing out, and at that time the osteopath pushed caudally with her hands. The procedure was repeated for 5 min.

       This technique has been proposed for patients suffering from GERD.

 

 

 

 

       


 
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