Evaluation of multimedia mobile application effects on patients with Thoracic Outlet Syndrome and Low Back Pain comparing with control group - a randomized controlled trial
Designing, implementing and evaluating a multimedia application for patients with Thoracic Outlet Syndrome and low back pain.
Design
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 180 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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
90 patients with Thoracic Outlet Syndrome will be allocated to the intervention group
90 patients with Thoracic Outlet Syndrome will be allocated to the control group
90 patients with low back pain will be allocated to the intervention group
90 patients with low back pain will be allocated to the control group
Main outcome variables
Disability questionnaire for patients with TOS; EAST test; Roland-Morris Questionnaire; Pain severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141221020380N3
Registration date:2018-07-14, 1397/04/23
Registration timing:prospective
Last update:2018-07-14, 1397/04/23
Update count:2
Registration date
2018-07-14, 1397/04/23
Registrant information
Name
Afshin Sarafinejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3261 5849
Email address
asarafinejad@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-01, 1397/05/10
Expected recruitment end date
2018-12-31, 1397/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of multimedia mobile application effects on patients with Thoracic Outlet Syndrome and Low Back Pain comparing with control group - a randomized controlled trial
Public title
Evaluation of a multimedia app for patients with Thoracic Outlet Syndrome and Low Back Pain
Purpose
Supportive
Inclusion/Exclusion criteria
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
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
360
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization method will be used based on random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Seven Alavi Gardens, Kerman University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2018-04-29, 1397/02/09
Ethics committee reference number
IR.KMU.REC.1397.036
Health conditions studied
1
Description of health condition studied
low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
2
Description of health condition studied
thoracic outlet syndrome
ICD-10 code
G54.0
ICD-10 code description
Brachial plexus disorders
Primary outcomes
1
Description
The Severity of Pain
Timepoint
At the beginning of the study (before the intervention) and 6 months after the intervention (use of the application)
Method of measurement
Numeric Rating Scale
2
Description
EAST Test
Timepoint
At the beginning of the study (before the intervention) and 6 months after the intervention (use of the application)
Method of measurement
By specialist: Record the amount of time a patient can hold his/her hands above the head
3
Description
Disability of Low Back Pain Patients
Timepoint
At the beginning of the study (before the intervention) and 6 months after the intervention (use of the application)
Method of measurement
Roland Morris Disability Questionnaire
4
Description
Thoracic Outlet Syndrome Disability Questionnaire
Timepoint
At the beginning of the study (before the intervention) and 6 months after the intervention (use of the application)
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: In the intervention group, the application install on the patient's mobile phone and the patient uses the application for 6 weeks.
Category
Rehabilitation
2
Description
Control Group: This group does not install the app and continue normal treatment
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam Al Anbia Physicians' Building.
Full name of responsible person
Mohammad Naeim Ahrari
Street address
Shariati Street, near to Tahmasb-Abad Cross.
City
Kerman
Province
Kerman
Postal code
۷۶۱۳۷۴۷۱۸۱
Phone
+98 34 3244 0091
Fax
Email
mnahrari@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhty
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3855
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
80
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
2
Sponsor
Name of organization / entity
شرکت پژوهشگران داده پرداز ابن سینا حکیم
Full name of responsible person
افشین صرافی نژاد
Street address
Pezeshk Blvd.
City
Kerman
Province
Kerman
Postal code
7618447951
Phone
+98 34 3261 5849
Email
a.sarafi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
شرکت پژوهشگران داده پرداز ابن سینا حکیم
Proportion provided by this source
20
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Saeideh Goharinejad
Position
MSc. Student
Latest degree
Bachelor
Other areas of specialty/work
Medical Informatics
Street address
Kerman, Shariati St., Alley No. 6
City
Kerman
Province
Kerman
Postal code
7614663454
Phone
+98 936 549 2286
Email
gohari.2490@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Afshin Sarafi Nejad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Informatics
Street address
Unit 1, First Floor, A-1 Block, Doctors Campus Residential Complex, Doctor Blvd, Kerman
City
Kerman
Province
Kerman
Postal code
00
Phone
+98 34 3261 5849
Email
asarafinejad@kmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Saeideh Goharinejad
Position
MSc. Student
Latest degree
Bachelor
Other areas of specialty/work
Medical Informatics
Street address
Kerman, Shariati St., Alley No. 6
City
Kerman
Province
Kerman
Postal code
00
Phone
+98 936 549 2286
Email
gohari.2490@gmail.com
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
To get the required permission from the patient and/or physician
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
We will publish a scientific paper about main outcome
When the data will become available and for how long
Access to information about the main outcome will be postponed until publication of articles
To whom data/document is available
The data will be available under certain condition to people who need them, after accepting and publishing the main article
Under which criteria data/document could be used
Part of data can be used for scientific and research purposes and as a valid document for screening and related executing jobs.
From where data/document is obtainable
Published articles will be available through journals.
What processes are involved for a request to access data/document
People can access to articles through journal subscriptions.