Protocol summary
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Study aim
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To develop a treatment protocol for frozen shoulder by comparing effectiveness of hydraulic distention along with shoulder mobilization and conventional physiotherapy.
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Design
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Randomized controlled clinical trial
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Settings and conduct
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Thq hospital wazirabad , patient and investigators are not blinded to type of treatment
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Participants/Inclusion and exclusion criteria
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Inclusion criteria include middle aged frozen shoulder patients with symptoms lasting more than 3 months. No abnormal finding on radiograph. Confirm diagnosis of adhesive capsulitis .
Exclusive criteria include patient having co morbidity except DM . Fibromyalgia, rotator cuff disease, major shoulder surgery and pregnancy
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Intervention groups
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Hydraulic distention along with shoulder mobilization techniques
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Main outcome variables
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Shoulder pain and disability scores determined through SPADI
General information
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Reason for update
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To add the dates of completion of project
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230906059367N1
Registration date:
2023-09-14, 1402/06/23
Registration timing:
prospective
Last update:
2024-11-13, 1403/08/23
Update count:
1
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Registration date
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2023-09-14, 1402/06/23
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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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2023-10-01, 1402/07/09
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Expected recruitment end date
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2023-11-01, 1402/08/10
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Actual recruitment start date
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2023-10-01, 1402/07/09
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Actual recruitment end date
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2023-12-05, 1402/09/14
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Trial completion date
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2024-03-31, 1403/01/12
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Scientific title
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Comparison of Effectiveness of hydraulic distention along with shoulder mobilization and conventional physiotherapy in treatment for frozen shoulder
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Public title
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Comparison of invasive vs non invasive procedures in treatment for frozen shoulder
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Middle age Frozen shoulder patients
Symptoms lasting more than 3 months
No abnormal findings on radiographs
Confirm diagnosis of adhesive capsulitis
Exclusion criteria:
Having co- morbidity except DM
Major shoulder surgery
Systemic inflammatory disease
Rotator cuff disease
Fibromyalgia
Pregnancy
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Age
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From 30 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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No information
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Sample size
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Target sample size:
30
Actual sample size reached:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization was web based computer generated software.No block or stratified method was used. randomised allocation was through sealed envelope opened separately for each patient wanted to participate in study .
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Other
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-09-05, 1402/06/14
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Ethics committee reference number
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1887
Health conditions studied
1
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Description of health condition studied
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Adhesive capsulitis is characterised by painful shoulder limitation also known as frozen shoulder due to capsular adhesion and shortness after and inflammatory response in capsule caused by mainly DM , mainly in women after 30 years . Other causes include shoulder injuries or surgery leading to movement difficulty , less common causes are othera metabolic and autoimmune diseases.
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Pain and shoulder limitations
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Timepoint
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Before intervention, one week after intervention then at 4th , 8th and 12th week.
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Method of measurement
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SPADI questionaire
Intervention groups
1
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Description
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Intervention group:
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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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THq hospital wazirabad
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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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Public
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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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Other
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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No - There is not 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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Undecided - It is not yet known if there will be 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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Spss files for results
Spss files for demographics data
Questionaire
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When the data will become available and for how long
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After completing study data will be available through email
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To whom data/document is available
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Healthcare practitioners and other researchers for systematic review of many studies
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Under which criteria data/document could be used
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If any researchers want to fill study gap and remove limitation in my studies we will provide data
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From where data/document is obtainable
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Through email
Jameelsabar@gmail.com
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What processes are involved for a request to access data/document
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If any researchers wants this data he or she will request through email
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Comments
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