| CTRI Number |
CTRI/2024/11/076842 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| 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
|
Effect Of Gongs Mobilization Versus
Conventional Physiotherapy In Frozen Shoulder |
|
Scientific Title of Study
|
Effect Of Gongs Mobilization and Conventional Physiotherapy On Pain And Range
Of Motion In Frozen Shoulder |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Megha Kandera |
| Designation |
MPT student |
| Affiliation |
mahatma gandhi university of medical sciences and technology |
| Address |
Mahatma Gandhi Physiotherapy Collage,Mahatma Gandhi University of Medical Sciences and Technology
,Ricco Institutional Area,Sitapura,Tonk Road
Jaipur
RAJASTHAN
302022
India |
| Phone |
6378264499 |
| Fax |
|
| Email |
megha1993@mgumst.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arvind Tomar |
| Designation |
Professor |
| Affiliation |
mahatma gandhi university of medical sciences and technology |
| Address |
Orhtopedic phyaiotherapy lab,Mahatma gandhi physiotherapy collage,mahatma gandhi university of medical sciences and technology
,ricco institutional area,sitapura,tonk road
Jaipur
RAJASTHAN
302022
India |
| Phone |
9784805133 |
| Fax |
|
| Email |
drarvindtomar@mgumst.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arvind Tomar |
| Designation |
Professor |
| Affiliation |
mahatma gandhi university of medical sciences and technology |
| Address |
Orhtopedic phyaiotherapy lab,Mahatma gandhi physiotherapy collage,mahatma gandhi university of medical sciences and technology
,ricco institutional area,sitapura,tonk road
RAJASTHAN
302022
India |
| Phone |
9784805133 |
| Fax |
|
| Email |
drarvindtomar@mgumst.org |
|
|
Source of Monetary or Material Support
|
| Mehatma Gandhi Physiotherapy Collage,Mahatma Gandhi University Of Medical Sciences and Technology, Riico Institutional Area,Sitapura,Tonk Road, Jaipur,Rajasthan(India),302022 |
|
|
Primary Sponsor
|
| Name |
Megha Kandera |
| Address |
25,abhinandan vihar colony, bajri mandi road, vaishali marg,panchywala, jaipur, rajasthan(india),302034 |
| 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 Arvind Tomar |
Mahatma Gandhi Hospital |
Room no.14 physiotherapy opd, basement, jaipur, rajasthan
Jaipur
RAJASTHAN |
9784805133
drarvindtomar@mgumst.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, mahatma gandhi medical collage and hospital, mgumst, jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional physiotherapy |
Finger ladder exercise, range of motion exercise, pendulam exercise
the duration of intervention is for 4 weeks, 5 days per week session. The technique is given as 2 sets of 15 repetitions in each sets with 5 minute of rest period. |
| Intervention |
gong’s mobilization |
Gong’s mobilization is done in a sitting position. All the participants are made to sit on a knee
height stool with no backrest keeping the spine straight and arm comfortably extended at the side
of the body. The therapist pushes the scapula of the affected side in a posterior to anterior
direction with one hand and with the other hand pushes the humeral head in an anterior to a
posterior direction parallel to the joint plain.Simultaneously the subject is asked to quickly and
powerfully perform shoulder abduction with no external rotation and elbow flexed to 90 degrees and also with the palm facing inwards and dorsum of the hand facing the
outwards.During the above time, the therapist kept pressing the humerus head along the long axis of the humerus. The therapist follows the movement of the subject’s shoulder when they were performing abduction. The speed of the movement is kept constant by the therapist.At the end range of movement, therapist accelerates the abduction movement.the duration of intervention is for 4 weeks, 5 days per week session. The technique is given as 2 sets of 15 repetitions in each sets with 5 minute of rest period. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Must be in frozen shoulder stage.
2. Age 40-60
3. Having a painful stiff shoulder for at least three months.
4. Having restriction of passive and active shoulder abduction and internal rotation in
comparison with opposite side. |
|
| ExclusionCriteria |
| Details |
A painful stiff shoulder after a trauma.
2. The presence of OA or signs of bony damage due to trauma on the radiographs of the
affected shoulder
3. Any local or systemic disease. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual analouge scale, goniometer |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual analouge scale, goniometer |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
07/12/2024 |
| Date of Study Completion (India) |
17/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
17/01/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Group A will receive gong’s mobilization. The duration of intervention is for 4 week , 5day per week session . The technique is given as two sets of 15 repetitions in each set with 5 min of rest period. Group B will receive conventional exercises Exercises include - Finger ladder, range of motion exercise,pendulam exercises. The duration of intervention is for 4 week , 5day per week session . The technique is given as two sets of 15 repetitions in each set with 5 min of rest period.
|