To evaluate the effectiveness of Mulligan Mobilization in patients with adhesive capsulitis.
Design
Single blind, parallel assigned, multi-centered, randomized clinical trials will be conducted on 48 participants
(two groups with 24 participants each) with history of adhesive capsulitis post CABG as assessed by pain with limited activities of daily livings, and randomization is being accomplished using simple random sampling by means of lottery method.
Settings and conduct
Faisalabad Institute of Cardiology. Participants are kept anonymous for conducting the single blind trial.
Participants/Inclusion and exclusion criteria
Male and female participants of age 40 to 60 years with restricted shoulder ROM post CABG, participants presenting with pain and restricted movements of shoulder (Lateral rotation, abduction and medial rotation) and limitations in activity of daily livings were included.
Participants with neurological disorders (e.g., stroke, Parkinson’s disease) leading to deficiency of shoulder muscles activity, severe trauma related to painful stiff shoulder, bony changes or osteoarthritis of the affected shoulder on radiographs, previous surgeries of shoulder ,manipulation under anesthesia of the affected shoulder and prior history of any diagnosed musculoskeletal issue of shoulder (Rotator cuff tendinitis, impingent) were excluded.
Intervention groups
Group A: The baseline treatment will be ROM exercises and then we will apply Mulligan technique (Movement with mobilization).
Group B: The baseline treatment for group B same as group A and then Maitland technique will be performed(Grade III mobilization).
Main outcome variables
Shoulder pain
Shoulder Disability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210815052188N1
Registration date:2021-08-28, 1400/06/06
Registration timing:retrospective
Last update:2021-08-28, 1400/06/06
Update count:0
Registration date
2021-08-28, 1400/06/06
Registrant information
Name
Soban Habib
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 41 8783707
Email address
dpt-fa14-022@tuf.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-21, 1400/02/31
Expected recruitment end date
2021-08-21, 1400/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Maitland and Mulligan’s Mobilization Technique in Treatment of Post CABG Adhesive Capsulitis
Public title
Effect of mobilization techniques for post CABG adhesive capsulitis
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Male and female participants of age 40 to 60 years with restricted shoulder range of motion post CABG
Participants presenting with pain and restricted movements of shoulder (Lateral rotation, abduction and medial rotation)
Limitations in activity of daily living
Exclusion criteria:
Neurological disorders (e.g., stroke, Parkinson’s disease) leading to deficiency of shoulder muscles activity
Severe trauma related to painful stiff shoulder
Bony changes or osteoarthritis of the affected shoulder on radiographs
Previous surgeries of shoulder
Manipulation under anesthesia of the affected shoulder
Prior history of any diagnosed musculoskeletal issue of shoulder (Rotator cuff tendinitis, impingent)
Age
From 40 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomized sampling technique was used to enroll participants into groups and they were allotted to two groups by lottery method
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants will not be aware of the study groups and this will be carried out by keeping them anonymous for the study period
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical and Technical Committee of The University of Faisalabad
Street address
P no. 64 Muslim Town B Block Sargodha Road
City
Faisalabad
Postal code
38000
Approval date
2021-05-21, 1400/02/31
Ethics committee reference number
TUF/DR/SA/MSPP/2021/213-230
Health conditions studied
1
Description of health condition studied
Adhesive capsulitis
ICD-10 code
M75.0
ICD-10 code description
Adhesive capsulitis of shoulder
Primary outcomes
1
Description
Primary outcome is shoulder pain
Timepoint
Shoulder pain before intervention, after 2nd week and 4th week
Method of measurement
Visual analogue scale
Secondary outcomes
1
Description
Shoulder Disability
Timepoint
before the treatment and after 4th week of treatment
Method of measurement
Shoulder pain and disability index
Intervention groups
1
Description
Intervention group A: Mulligan mobilization and range of motion exercises
Category
Treatment - Other
2
Description
Intervention group B: Maitland mobilization and range of motion exercises
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faisalabad Institute of Cardialogy
Full name of responsible person
Dr Amir Mushtaq
Street address
P no. 64 Muslim Town B Block Sargodha Road
City
Faisalabad
Postal code
38000
Phone
+92 41 6076222
Email
sobanhabib64@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasmin Physiotherapy Center
Full name of responsible person
Osama Ranzam
Street address
Sargodha Road. near muslim town 3, opposite KIA motors
City
Faisalabad
Postal code
38000
Phone
+92 41 8785675
Email
osamaramzan@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasmin Physiotherapy Center
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Yasmin Physiotherapy Center
Full name of responsible person
Osama Ramzan
Position
Clinical Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Sargodha Road, near Muslim town 3, Opposite KIA motors
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 8785675
Email
osamaramzan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasmin Physiotherapy Center
Full name of responsible person
Osama Ramzan
Position
Clinical Physiotherapist
Latest degree
Master
Other areas of specialty/work
Orthopedics
Street address
Park view city, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35433053
Email
osamaramzan@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yasmin Physiotherapy Center
Full name of responsible person
Osama Ramzan
Position
Clinical Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Park view city, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35433053
Email
osamaramzan@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
As we signed and assured the participants that their data will not be shared anyway where else other than current study
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The primary and secondry outcome measure data will be shared and no further details regarding personal information will be provided
When the data will become available and for how long
Starting in January, 2022
To whom data/document is available
For everyone regarding field
Under which criteria data/document could be used
Whoever will request for data
From where data/document is obtainable
Through email
What processes are involved for a request to access data/document
An email starting the use of data will be appreciated