| CTRI Number |
CTRI/2018/11/016409 [Registered on: 26/11/2018] Trial Registered Prospectively |
| Last Modified On: |
22/11/2018 |
| 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
|
Effectiveness of applying mobilization to shoulder joint in weight bearing position(on all fours)in patients with shoulder problem |
|
Scientific Title of Study
|
Effectiveness Of Mobilization With Movement In Weight Bearing Position On Pain,Shoulder Range Of Motion And Function In Patients With Shoulder Dysfunction |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Reshma Subhash |
| Designation |
Post-Graduate Student |
| Affiliation |
Indian Spinal Injuries Centre - Institute of Rehabilitation Studies |
| Address |
Musculoskeletal Lab , Second Floor , ISIC- Institute Of Rehabilitation
Sciences , Opposite Vasant Valley School, Sector-C, Vasant Kunj,
New Delhi.
South
DELHI
110070
India |
| Phone |
9999558038 |
| Fax |
|
| Email |
reshmasubhash25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Meena Makhija |
| Designation |
Assistant Professor |
| Affiliation |
Indian Spinal Injuries Centre - Institute of Rehabilitation Studies |
| Address |
Musculoskeletal Lab , Second Floor , ISIC- Institute Of Rehabilitation Sciences , Opposite Vasant Valley School, Sector C ,Vasant Kunj,
New Delhi
South
DELHI
110070
India |
| Phone |
9910011816 |
| Fax |
|
| Email |
makhijameena81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Meena Makhija |
| Designation |
Assistant Professor |
| Affiliation |
Indian Spinal Injuries Centre - Institute of Rehabilitation Studies |
| Address |
Musculoskeletal Lab , Second Floor , ISIC- Institute Of Rehabilitation Sciences , Opposite Vasant Valley School, Sector C ,Vasant Kunj,
New Delhi
South
DELHI
110070
India |
| Phone |
9910011816 |
| Fax |
|
| Email |
makhijameena81@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Spinal Injuries Centre - Instititute Of Rehabilitation Sciences , Opposite Vasant Valley
School, Sector- C, Vasant Kunj , New Delhi -110070 |
|
|
Primary Sponsor
|
| Name |
Indian Spinal Injuries Centre Instititute Of Rehabilitation Sciences |
| Address |
Indian Spinal Injuries Centre - Instititute Of Rehabilitation Sciences , Opposite Vasant Valley
School, Sector- C, Vasant Kunj , New Delhi -110070 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Reshma Subhash |
Sports injury centre |
Department of physiotherapy,
First Floor,
Safdarjung Hospital, Mahatma Gandhi Marg, Safdarjung Campus, New Delhi, Delhi 110029
South
DELHI |
9999558038
reshmasubhash25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Indian Spinal Injuries Centre (ISIC), New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M754||Impingement syndrome of shoulder, (2) ICD-10 Condition: M755||Bursitis of shoulder, (3) ICD-10 Condition: M758||Other shoulder lesions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A- Mulligans Mobilization with Movement in weight bearing position |
Mulligans Mobilization with Movement in weight bearing position,capsular stretching, ROM and strengthening exercises of shoulder, superficial heating |
| Comparator Agent |
Group B Control group |
Capsular stretching,ROM and strengthening exercises of shoulder superficial heating |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient with restriction more than 30â—¦ in elevation as compared to contralateral side.
|
|
| ExclusionCriteria |
| Details |
1.Diagnosed case of other shoulder conditions like instability, bilateral shoulder disorders, and complete rotator cuff tear .
2.Diagnosed with any neurological, orthopedic disorder related to upper limb and cervical spine.
3.History of infection, systemic illness, major trauma, tumor, previous surgery or deformity of shoulder and spine
4.History of cognitive impairment
5.Subjects contraindicated for Mulligan mobilization
6.Patient unable to do weight bearing in all fours position.
7.Severe pain at shoulder (NPRS more than 7).
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.NPRS
2.Range Of Motion
3.SPADI |
1st sitting
6th sitting |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Pain
2.ROM
3.Function |
1st sitting
6th sitting |
|
|
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)
|
26/11/2018 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
AIM-To find out the effectiveness of
shoulder girdle mobilization with movement in weight bearing on pain, shoulder range of motion and
function in patients with shoulder dysfunction.
HYPOTHESIS
H1: There
will be a significant difference between
the effectiveness of shoulder girdle Mobilization with Movement (MWM) in
weight bearing position in conjunction with
conventional physiotherapy and conventional physiotherapy treatment alone on
pain (VAS) in subjects with shoulder dysfunction.
H2: There is
significant difference between the effectiveness of shoulder girdle
Mobilization with Movement in weight bearing position in conjunction with
conventional physiotherapy and conventional physiotherapy treatment alone on shoulder range of
motion in subjects with shoulder dysfunction.
H3: There
will be a significant difference between
the effectiveness of shoulder girdle Mobilization with Movement (MWM) in
weight bearing position in conjunction with
conventional physiotherapy and conventional physiotherapy treatment alone on
shoulder function (SPADI) in subjects with shoulder dysfunction.
|