| CTRI Number |
CTRI/2024/01/061953 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
25/01/2024 |
| 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 Passive Stretching Versus Muscle Energy Technique On Pain, Rom And Function In Patients With Adhesive Capsulitis -a Comparative Study |
|
Scientific Title of Study
|
EFFECTIVENESS OF PASSIVE STRETCHING VERSUS MUSCLE ENERGY TECHNIQUE ON PAIN, ROM AND FUNCTION IN PATINETS WITH ADHESIVE CAPSULITIS -A COMPARATIVE STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mrunalini Netaji Jadhav |
| Designation |
Master of Musculoskeletal physiotherapy student |
| Affiliation |
Maharashtra Institute of Physiotherapy |
| Address |
Maharashtra Institute of Physiotherapy musculoskeletal opd numer15 MIMSR Medical Campus Ambejogai road Latur
Latur
MAHARASHTRA
413512
India
Latur
MAHARASHTRA
413512
India |
| Phone |
7709071694 |
| Fax |
|
| Email |
mrunalinijadhav4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurav Bhatnagar |
| Designation |
professor and HOD of Musculoskeletal Physiotherapy Department |
| Affiliation |
Maharashtra Institute of Physiotherapy |
| Address |
Maharashtra Institute of Physiotherapy muscloskeletal opd number 15 MIMSR Medical Campus Ambejogai road Latur
Latur
MAHARASHTRA
413512
India
Latur
MAHARASHTRA
413512
India |
| Phone |
7415505920 |
| Fax |
|
| Email |
bhatnagargaurav8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gaurav Bhatnagar |
| Designation |
professor and HOD of Musculoskeletal Physiotherapy Department |
| Affiliation |
Maharashtra Institute of Physiotherapy |
| Address |
Maharashtra Institute of Physiotherapy musculoskeletal opd number 15 MIMSR Medical Campus Ambejogai road Latur
Latur
MAHARASHTRA
413512
India
MAHARASHTRA
413512
India |
| Phone |
7415505920 |
| Fax |
|
| Email |
bhatnagargaurav8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharashtra Institute of Physiotherapy latur |
|
|
Primary Sponsor
|
| Name |
Maharashtra Institute Of Physiotherapy , Latur |
| Address |
Maharashtra Institute of Physiotherapy MIMSR Medical Campus Ambejogai road Latur
Latur
MAHARASHTRA
413512
India |
| 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 |
| DrMrunalini Netaji Jadhav |
Maharashtra Institute Of Physiotherapy |
Department of Musculoskeletal Physiotherapy
Maharashtra Institute Of Physiotherapy, MIMSR Medical Campus, ambajogai road Latur
MAHARASHTRA
Latur
MAHARASHTRA |
7709071694
mrunalinijadhav4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maharashtra Institute Of Physiotherapy Latur ethical committee |
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 |
Nil |
Nil |
| Intervention |
Passive muscle Stretching,Muscle Energy Technique |
passive stretching for shoulder flexion, extension, internal, external and abduction 10 times over 5 sessions for two weeks
muscle energy technique for five repetitions per set, five sets per session for 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
age group 30-60
willing to participate
male and females
participants with unilateral Adhesive Capsulitis having restriction in passive movements
patients with controlled diabetic
with stage III includes |
|
| ExclusionCriteria |
| Details |
1.History of shoulder surgery 2.Fracture 3.Dislocation 4.Recent trauma 5.Having radiculopathy of upper limb 6.Neurological disorders of upper limb |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Range of motion and SPADI |
pre treatment assessment
After 2 weeks treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No secondary outcomes |
at baseline two weeks |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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 2 |
|
Date of First Enrollment (India)
|
06/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
06/02/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="20" |
|
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
|
My study is to see Effectiveness of Passive stretching Versus Muscle Energy Technique on Pain, Range Of motion And Function In Patients With Adhesive Capsulitis - A Comparative study Sample size is 54.Outcome measure are Range of motion for flexion, Extension, abduction, external rotation and internal rotation of shoulder and Shoulder pain and disability Index . |