Comparison of scapular mobilization with and without scapular recognition exercises on pain, scapular ranges and disability in adhesive capsulitis patients.
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General information
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36
36
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2023-01-30, 1401/11/10
2023-01-30 00:00:00
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2023-04-07, 1402/01/18
2023-04-07 00:00:00
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2023-12-03, 1402/09/12
2023-12-03 00:00:00
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Trial complete
Trial complete
Protocol summary
Study aim
Comparison of scapular mobilization with and without scapular recognition exercises on pain, scapular ranges and disability in adhesive capsulitis patients.
Design
Single blinded randomised controlled trial, conducted on 36 patients, equally divided into two groups, single centered study.
Settings and conduct
Riphah International University, Lahore , patient single blinded.
Participants/Inclusion and exclusion criteria
Male and female patients .
Patients between the ages of 40 to 60 years old .
Patients with shoulder pain that interfered with daily activities .
Patients with Numeric pain rating scale score of at least 3 points .
Unilateral shoulder adhesive capsulitis .
Patients with inability to elevate the arm above 100 degrees in the plane of the scapula .
Exclusion criteria
Presence of any shoulder condition that is a contraindication for exercising the shoulder joint, such as cancer, active infection, active inflammatory disease, recent dislocations, subluxations, surgery and fractures around the shoulder region z
Patients were excluded if they had no signs of scapular dyskinesia .
The Scapular Dyskinesia Test (SDT) was performed to confirm the presence of scapular dyskinesia .
Intervention groups
36 patients will be randomly divided into control and experimental groups. The control group will receive routine scapular mobilization while the experimental group will receive spinal recognition exercises along with the scapular mobilization exercises
Main outcome variables
1_Pain Intensity 2_Scapular Ranges 3_Level of Disability
General information
Reason for update
Trial complete
Acronym
RCT
IRCT registration information
IRCT registration number:IRCT20190717044238N3
Registration date:2023-01-24, 1401/11/04
Registration timing:prospective
Last update:2024-06-05, 1403/03/16
Update count:1
Registration date
2023-01-24, 1401/11/04
Registrant information
Name
Fareeha Amjad
Name of organization / entity
The University of Lahore
Country
Pakistan
Phone
+92 42 99200600
Email address
fari_fairy22@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-28, 1401/11/08
Expected recruitment end date
2023-05-28, 1402/03/07
Actual recruitment start date
2023-01-30, 1401/11/10
Actual recruitment end date
2023-04-07, 1402/01/18
Trial completion date
2023-12-03, 1402/09/12
Scientific title
Comparison of scapular mobilization with and without scapular recognition exercises on pain, scapular ranges and disability in adhesive capsulitis patients.
Public title
Comparison of scapular mobilization with and without scapular recognition exercises on pain, scapular ranges and disability in adhesive capsulitis patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male and female patients
Patients between the ages of 40 to 60 years old
Patients with shoulder pain that interfered with daily activities
Patients with Numeric pain rating scale score of at least 3 points
Unilateral shoulder adhesive capsulitis.
Patients with inability to elevate the arm above 100 degrees in the plane of the scapula
Patients with positive scapular dyskinesia test
Exclusion criteria:
Presence of any shoulder condition that is a contraindication for exercising the shoulder joint, such as cancer, active infection, active inflammatory disease, recent dislocations, subluxations, surgery and fractures around the shoulder region.
Patients were excluded if they had no signs of scapular dyskinesia while performing Scapular Dyskinesia Test(SDT)
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
36
Actual sample size reached:
36
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects were randomly assigned into two groups, A & B with each containing 18 subjects by lottery method.
Blinding (investigator's opinion)
Single blinded
Blinding description
After fulfilling inclusion criteria patients who will participate in the study will be blind.
Placebo
Not used
Assignment
Parallel
Other design features
no
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethical committe
Street address
Riphah international university,Lahore
City
Lahore
Postal code
54770
Approval date
2022-03-04, 1400/12/13
Ethics committee reference number
REC/RCR & AHS/22/0162
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
Pain Intensity
Timepoint
Before intervention and after 4 weeks of intervention
Method of measurement
Numeric Pain Rating Scale
2
Description
Shoulder range of motion
Timepoint
Before intervention and after 4 weeks of intervention
Method of measurement
Inclinometer
Secondary outcomes
1
Description
level of disability
Timepoint
Before intervention and after 4 weeks of intervention
Method of measurement
SPADI(Shoulder Pain and Disability Index)
Intervention groups
1
Description
Intervention group A: Scapular mobilization with scapular dynamic exercises
Category
Treatment - Other
2
Description
Intervention group B : Scapular mobilization without scapular dynamic exercises
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Riphah international university,Lahore campus
Full name of responsible person
Hadiqa Naeem
Street address
Riphah International University
City
Lahore
Postal code
54770
Phone
+92 309 5305385
Email
hadiqa621@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Hadiqa Naeem
Street address
Riphah International University,Lahore
City
Lahore
Postal code
54770
Phone
+92 309 5305385
Email
hadiqa621@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah International University
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Hadiqa Naeem
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Riphah International University
City
Lahore
Province
Punjab
Postal code
54770
Phone
+92 309 5305385
Email
hadiqa621@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University Of Lahore
Full name of responsible person
Fareeha Amjad
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House no. 41 B, Iqbal Avenue, Phase-III, Lahore
City
Lahore
Province
Punjab
Postal code
545150
Phone
+92 42 99200600
Email
fari_fairy22@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
The University Of Lahore
Full name of responsible person
Fareeha Amjad
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House no. 41 B, Iqbal Avenue, Phase-III, Lahore, Pakistan
City
Lahore
Province
Punjab
Postal code
55150
Phone
+92 42 99200600
Email
fari_fairy22@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All collected identified IPD
When the data will become available and for how long
Data will be available after the completion of study and will remain available till 6 months
To whom data/document is available
Data will be available for other people almost 6 months after the completion of study
Under which criteria data/document could be used
The data/document could be used by communicating with the principle investigator "Hadiqa Naeem" on email address: hadiqa621@gmail.com
From where data/document is obtainable
Hadiqa Naeem,hadiqa621@gmail.com
What processes are involved for a request to access data/document
The data/document could be used by communicating with the principle investigator "Hadiqa Naeem" on institutional email address: hadiqa621@gmail.com