| 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
|
|
|
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
|
|
|
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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