Protocol summary
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Study aim
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Designing, implementing and evaluating a multimedia application for patients with Thoracic Outlet Syndrome and low back pain.
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Design
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This study is a randomized trial with intervention and control groups, that will be performed as a parallel method. The application will be installed on 88 patients' smartphones suffering from low back pain or thoracic outlet syndrome and the improvement of symptoms will be measured after a certain period of time compared to the control group.
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Settings and conduct
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This study will be performed on patients with low back pain and thoracic outlet syndrome. analyzer and patients will be blind. The study sampling will be performed in Khatam Al Anbia medical center.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
1- Minimum age 18 and maximum age 65 years
2-Participants should have low back pain or thoracic outlet syndrome
3. Patients in the intervention group should have a smartphone
4. Patients in the intervention group should have the ability to work with the smartphone
Exclusion criteria:
1- If the patient has additional disease
2. The patient has had surgery on the back or shoulder and neck in the last 6 months
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Intervention groups
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44 patients with Thoracic Outlet Syndrome will be allocated to the intervention group
44 patients with Thoracic Outlet Syndrome will be allocated to the control group
44 patients with low back pain will be allocated to the intervention group
44 patients with low back pain will be allocated to the control group
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Main outcome variables
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Disability questionnaire for patients with TOS; EAST test; Roland-Morris Questionnaire; Pain severity
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20141221020380N3
Registration date:
2018-07-14, 1397/04/23
Registration timing:
prospective
Last update:
2019-05-23, 1398/03/02
Update count:
2
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Registration date
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2018-07-14, 1397/04/23
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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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2019-04-01, 1398/01/12
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Expected recruitment end date
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2019-07-15, 1398/04/24
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of multimedia mobile application effects on patients with Thoracic Outlet Syndrome and Low Back Pain comparing with control group - a randomized controlled trial
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Public title
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Evaluation of a multimedia app for patients with Thoracic Outlet Syndrome and Low Back Pain
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
People's willingness to complete the questionnaire and use the software
The patient has an adequate level of cognitive and physical literacy
familiar with how the smartphone works.
Exclusion criteria:
Patients with any other illness will exclude from the study
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Data analyser
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Sample size
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Target sample size:
176
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, simple randomization method will be used based on random number table.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The participants do not know in which group, intervention or control, will be allocated. The data analyst does not know which patient will be allocated to intervention or control groups.
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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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Ethics committees
1
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Ethics committee
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Approval date
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2018-04-29, 1397/02/09
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Ethics committee reference number
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IR.KMU.REC.1397.036
Health conditions studied
1
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Description of health condition studied
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low back pain
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ICD-10 code
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M54.5
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ICD-10 code description
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Low back pain
2
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Description of health condition studied
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thoracic outlet syndrome
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ICD-10 code
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G54.0
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ICD-10 code description
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Brachial plexus disorders
Primary outcomes
1
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Description
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The Severity of Pain
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Timepoint
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At the beginning of the study (before the intervention) and 6 weeks after the intervention (use of the application)
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Method of measurement
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Numeric Rating Scale
2
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Description
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EAST Test
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Timepoint
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At the beginning of the study (before the intervention) and 6 weeks after the intervention (use of the application)
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Method of measurement
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By specialist: Record the amount of time a patient can hold his/her hands above the head
3
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Description
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Disability of Low Back Pain Patients
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Timepoint
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At the beginning of the study (before the intervention) and 6 weeks after the intervention (use of the application)
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Method of measurement
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Roland Morris Disability Questionnaire
4
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Description
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Thoracic Outlet Syndrome Disability Questionnaire
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Timepoint
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At the beginning of the study (before the intervention) and 6 weeks after the intervention (use of the application)
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Method of measurement
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Questionnaire
Intervention groups
1
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Description
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Intervention Group: In the intervention group, the application install on the patient's mobile phone and the patient uses the application for 6 weeks.
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Category
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Rehabilitation
2
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Description
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Control Group: This group does not install the app and continue normal treatment
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Category
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Rehabilitation
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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Kerman University of Medical Sciences
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Proportion provided by this source
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80
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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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Academic
2
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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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شرکت پژوهشگران داده پرداز ابن سینا حکیم
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Proportion provided by this source
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20
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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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Persons
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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To get the required permission from the patient and/or physician
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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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Not applicable
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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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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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We will publish a scientific paper about main outcome
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When the data will become available and for how long
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Access to information about the main outcome will be postponed until publication of articles
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To whom data/document is available
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The data will be available under certain condition to people who need them, after accepting and publishing the main article
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Under which criteria data/document could be used
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Part of data can be used for scientific and research purposes and as a valid document for screening and related executing jobs.
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From where data/document is obtainable
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Published articles will be available through journals.
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What processes are involved for a request to access data/document
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People can access to articles through journal subscriptions.
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Comments
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