Protocol summary
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Study aim
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Comparison of scapular mobilization with and without scapular recognition exercises on pain, scapular ranges and disability in adhesive capsulitis patients.
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Design
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Single blinded randomised controlled trial, conducted on 36 patients, equally divided into two groups, single centered study.
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Settings and conduct
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Riphah International University, Lahore , patient single blinded.
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Participants/Inclusion and exclusion criteria
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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 .
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Intervention groups
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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
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Main outcome variables
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1_Pain Intensity 2_Scapular Ranges 3_Level of Disability
General information
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Reason for update
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Trial complete
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Acronym
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RCT
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IRCT registration information
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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
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Registration date
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2023-01-24, 1401/11/04
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-01-28, 1401/11/08
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Expected recruitment end date
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2023-05-28, 1402/03/07
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Actual recruitment start date
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2023-01-30, 1401/11/10
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Actual recruitment end date
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2023-04-07, 1402/01/18
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Trial completion date
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2023-12-03, 1402/09/12
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Scientific title
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Comparison of scapular mobilization with and without scapular recognition exercises on pain, scapular ranges and disability in adhesive capsulitis patients.
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Public title
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Comparison of scapular mobilization with and without scapular recognition exercises on pain, scapular ranges and disability in adhesive capsulitis patients.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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)
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Age
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From 40 years old to 60 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
36
Actual sample size reached:
36
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The subjects were randomly assigned into two groups, A & B with each containing 18 subjects by lottery method.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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After fulfilling inclusion criteria patients who will participate in the study will be blind.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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no
Ethics committees
1
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Ethics committee
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Approval date
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2022-03-04, 1400/12/13
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Ethics committee reference number
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REC/RCR & AHS/22/0162
Health conditions studied
1
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Description of health condition studied
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Adhesive Capsulitis
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ICD-10 code
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M75.0
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ICD-10 code description
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Adhesive capsulitis of shoulder
Primary outcomes
1
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Description
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Pain Intensity
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Timepoint
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Before intervention and after 4 weeks of intervention
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Method of measurement
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Numeric Pain Rating Scale
2
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Description
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Shoulder range of motion
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Timepoint
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Before intervention and after 4 weeks of intervention
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Method of measurement
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Inclinometer
Secondary outcomes
1
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Description
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level of disability
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Timepoint
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Before intervention and after 4 weeks of intervention
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Method of measurement
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SPADI(Shoulder Pain and Disability Index)
Intervention groups
1
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Description
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Intervention group A: Scapular mobilization with scapular dynamic exercises
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Category
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Treatment - Other
2
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Description
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Intervention group B : Scapular mobilization without scapular dynamic exercises
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Riphah International University
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All collected identified IPD
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When the data will become available and for how long
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Data will be available after the completion of study and will remain available till 6 months
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To whom data/document is available
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Data will be available for other people almost 6 months after the completion of study
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Under which criteria data/document could be used
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The data/document could be used by communicating with the principle investigator "Hadiqa Naeem" on email address: hadiqa621@gmail.com
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From where data/document is obtainable
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Hadiqa Naeem,hadiqa621@gmail.com
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What processes are involved for a request to access data/document
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The data/document could be used by communicating with the principle investigator "Hadiqa Naeem" on institutional email address: hadiqa621@gmail.com
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Comments
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N/A