Efficacy of tele-rehabilitation compared to office based physical therapy in army patients diagnosed with shoulder tendinopathy and therapeutic protocol
The purpose of this study is to investigate and compare pain, function and quality of life in participant with shoulder tendinopathy before, one month and three months after the start of treatment between two groups of Tele-rehabilitation and rehabilitation in the clinic.
Design
A randomized, controlled, parallel-group, phase 3 clinical trial conducted on 40 patients with shoulder tendinopathy.
Settings and conduct
The study is carried out in the physical medicine and rehabilitation department of Imam Reza Hospital in Tehran. The evaluator does not know the grouping of the participants.
Participants/Inclusion and exclusion criteria
Military personnel with shoulder tendinopathy
Intervention groups
Intervention group: patients receiving remote rehabilitation.
Control group: patients who receive physiotherapy exercises in the clinic.
Both groups of exercises include Codman exercise and strengthening exercises for rotator cuff muscles including supraspinatus, infraspinatus, teres minor and subscapularis as well as strengthening scapula stabilizing muscles including upper, middle and lower trapezius, rhomboid muscles, levator scapulae, pectoralis minor and major. receives
Main outcome variables
Pain by VAS scale
Musculoskeletal disorders of the upper limb with the DASH questionnaire
Quality of life with WHOQOL-BREF questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180416039323N5
Registration date:2024-11-16, 1403/08/26
Registration timing:prospective
Last update:2024-11-16, 1403/08/26
Update count:0
Registration date
2024-11-16, 1403/08/26
Registrant information
Name
Zahra Rezasoltani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4382 3476
Email address
z.rezasoltani@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-21, 1403/09/01
Expected recruitment end date
2025-04-21, 1404/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of tele-rehabilitation compared to office based physical therapy in army patients diagnosed with shoulder tendinopathy and therapeutic protocol
Public title
Efficacy of tele-rehabilitation in shoulder tendinopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Military personnel
Have pain for more than 6 weeks
Diagnosis of shoulder tendinopathy based on MRI findings
The initial pain level should be between 3 and 8 based on the VAS scale
Have a phone with Android operating system
Have the ability to use a smart phone
Exclusion criteria:
If he had another treatment or surgery in the last three months
Have symptoms of cervical radiculopathy
Have upper limb paresthesia
Have a complete tear of the rotator cuff muscles
Have a history of tumor and malignancy in the shoulder
Have an active infection in the shoulder joint or surrounding tissues
Have coagulation disorders or take anticoagulants
Have systemic rheumatological disorders
Have a history of upper limb fracture
Has used systemic corticosteroids in the last month
Age
From 18 years old to 50 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with different block sizes of 2, 4 and 8 is used. Initially, the block sizes are chosen randomly. Then, for each block, different permutations are determined for equal group size. Finally, one of the permutations is randomly selected.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of AJA University of Medical Sciences
Street address
Aja University of Medical Sciences, Shahid Etemadzadeh Street, West Fatemi Street
City
Tehran
Province
Tehran
Postal code
1411718546
Approval date
2024-06-12, 1403/03/23
Ethics committee reference number
IR.AJAUMS.REC.1403.073
Health conditions studied
1
Description of health condition studied
Shoulder tendinopathy
ICD-10 code
M67.813
ICD-10 code description
Other specified disorders of tendon, right shoulder
Primary outcomes
1
Description
pain
Timepoint
Before, one month and three months after the start of treatment
Method of measurement
Visual Analog Scale
2
Description
Musculoskeletal disorders of the upper limb
Timepoint
Before, one month and three months after the start of treatment
Method of measurement
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Secondary outcomes
1
Description
Quality of Life
Timepoint
Before, one month and three months after the start of treatment
Method of measurement
World Health Organization Quality-of-Life Scale (WHOQOL-BREF)
Intervention groups
1
Description
Intervention group: Patients receiving tele-rehabilitation. The intervention group receive sports exercises includes Codaman exercises, strengthen the rotator cuff muscles, including the supraspinatus, infraspinatus, teres minor, and subscapularis, as well as strengthening the scapula stabilizing muscles, including the upper, middle, and lower trapezius, rhomboid muscles, levator scapulae, pectoralis minor, and major through Bale messenger.
Category
Rehabilitation
2
Description
Control group: Patients who receive physiotherapy exercises in the clinic. The control group receive exercises included Codman exercises and exercises to strengthen the rotator cuff muscles, including supraspinatus, infraspinatus, teres minor, and subscapularis, as well as strengthening the stabilizing muscles of the scapula, including upper, middle, and lower trapezius, rhomboid muscles, levator scapulae, pectoralis minor, and major in the physiotherapy clinic.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Physical Medicine and Rehabilitation of Imam Reza Hospital
Full name of responsible person
Zahra Rezasoltani
Street address
Aja University of Medical Sciences, Shahid Etemadzadeh Street, West Fatemi Street
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 912 394 7633
Email
z.rezasoltani@ajaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Reza Mosaed
Street address
Aja University of Medical Sciences, Shahid Etemadzadeh Street, West Fatemi Street
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
z.rezasoltani@ajaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh University of Medical Sciences
Proportion provided by this source
100
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
Person responsible for general inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Zahra Rezasoltani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Aja University of Medical Sciences, Shahid Etemadzadeh Street, West Fatemi Street
City
Tehran
Province
Tehran
Postal code
1411718546
Phone
+98 21 4382 3476
Email
z.rezasoltani@ajaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Zahra Rezasoltani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Aja University of Medical Sciences, Shahid Etemadzadeh Street, West Fatemi Street
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 4382 3476
Fax
Email
z.rezasoltani@ajaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Zahra Rezasoltani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Aja University of Medical Sciences, Shahid Etemadzadeh Street, West Fatemi Street
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 4382 3476
Fax
Email
z.rezasoltani@ajaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only primary and secondary outcome data are reported
When the data will become available and for how long
Considering that the data will be available in the form of an article, there is no specific time frame for this.
To whom data/document is available
Researchers are trained to conduct clinical trial studies and review studies
Under which criteria data/document could be used
If need more information for systematic review or meta-analysis studies
From where data/document is obtainable
Corresponding author of the article
What processes are involved for a request to access data/document
Sending an email to the Corresponding author and providing the specifications and code of the study that is going to use the data of the present study