Comparison of telephysicaltherapy with physicaltherapy in clinic based on exercise therapy and self- release on pain, range of motion, function and satisfaction in patients with subacromial pain syndrome
Comparison of telephysicaltherapy with physicaltherapy in clinic based on exercise therapy and self- release on pain, range of motion, function and satisfaction in patients with subacromial pain syndrome
Design
randomised control trial with blind assessor , parallel group trial , stage3 on 33 patients ,randomisation sequence carried out with writing letters on papers.
Settings and conduct
this investigation is going to be done at rehabilitation school of the university of Tehran . in this single blinde trial the external assessor will assess patients at first and 5th and 10th sessions.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1:internet accessibility
2:to be literate
3:suffering from subacromial pain syndrome
4:patients have to consent to participate in this study
5:aged between 20-5- years
Exclusion criteria:
1:history of shoulder pain less than 3 months
2:history of unsteadiness or dizziness
3:history of falling
4:blurred vision
5:history of new disease or an acute relapse
6:history of recent shoulder surgery
Intervention groups
interventional 1:in this group ,exercise therapies and self-releases with tennis ball for subacromial pain syndrome will be given during 3 weeks . sessions will be held via video calls in smart phones or laptobs.
interventional 2:in this group exercise therapies and self-releases with tennis ball for subacromial pain syndrome will be given during 3 weeks . sessions will be held by sending instructional videos in smart phones or laptobs.
control :educating exercise therapies and releases will be done by therapist at clinic in order to decrease pain and improve range of motion during 3 weeks .
Main outcome variables
pain - range of motion - satisfaction - changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220622055252N1
Registration date:2022-12-29, 1401/10/08
Registration timing:registered_while_recruiting
Last update:2022-12-29, 1401/10/08
Update count:0
Registration date
2022-12-29, 1401/10/08
Registrant information
Name
Fatemeh Ehteshami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3436 9369
Email address
fateme.ehteshami94@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-04-04, 1402/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of telephysicaltherapy with physicaltherapy in clinic based on exercise therapy and self- release on pain, range of motion, function and satisfaction in patients with subacromial pain syndrome
Public title
comparison of telephysicaltherapy with in-clinic physical therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
internet accessibilty
to be literate
suffering from subacromial pain syndrome
patients have to consent to participate in this study
aged between 20-50 years
Exclusion criteria:
history of shoulder pain less than 3 months
history of unsteadiness and dizziness
history of falling
blurred vision
history of new disease or an acute relapse
history recent shoulder surgery
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
33
Randomization (investigator's opinion)
Randomized
Randomization description
randomisation will be done by putting separate papers in a bag with A , B ,C letters are written on them . a volunteer who pick A paper enter in the first intereventional group . then who pick B letter will be categorized in second interventional group. at last who pick C letter will be in control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
his single-blinded study has been blinded at the level of the assessor to conceal treatment group identity after randomization. the assessor is also a physical therapist and will do the assessments at the 1st, 5th, and 10th sessions. We will request from the assessor colleagues to not ask patients about their intervention group and patients not reveal their treatment plan.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Tehran University of Medical Science
Street address
room 605,Secretariat of the Ethics Committee in Biomedical Research of the University, Research and Technology Vice-ChancellorوCentral Organization of the University, 6th Floor,Keshavarz Blvd., Quds St
City
Tehran
Province
Tehran
Postal code
65111-11489
Approval date
2022-05-02, 1401/02/12
Ethics committee reference number
IR.TUMS.FNM.REC.1401.015
Health conditions studied
1
Description of health condition studied
Shoulder subacromial pain syndrome
ICD-10 code
M75.40
ICD-10 code description
Impingement syndrome of unspecified shoulder
Primary outcomes
1
Description
measuring percentage of telehealth patient satisfaction
Timepoint
measuring patient satisfaction after session 5th and 10th in telehealth group
Method of measurement
The modified Telehealth Satisfaction Scale: the purpose for using this questionnaire is to measure the quality of care for patients in the telerehabilitation group.it has many questions to survey how much a patient is satisfied with different aspects of this method for example the ease of use or manner of therapists.
2
Description
measuring patient satisfaction from in-clinic physical therapy care
Timepoint
measuring patient satisfaction after session 5th and 10th in-clinic(conventional)group
Method of measurement
The Patient Satisfaction with Physical Therapy care: it will be used specifically to measure the quality of care at clinic by therapist .for example investigates different aspects of commuting to rehabilitation center or survey the quality of hands-on treatment.
3
Description
measuring patient pain scale
Timepoint
measurment of patient's pain at the basement(before beginning) , and after 5th and 10th sessions
Method of measurement
The Visual Analogue Scale (VAS)
4
Description
measurment of patient's pain and function
Timepoint
measurment of patient's pain and function at the basement(before beginning) , and after 5th and 10th( last)sessions
Method of measurement
The Shoulder Pain and Disability Index questionnaire(SPADI)
5
Description
measurment of shoulder joint range of motion angle
Timepoint
measurment of patient's shoulder range of motion at the basement(before beginning) , and after 5th and 10th( last)sessions
Method of measurement
Goniometery
6
Description
measuring the rate of patients change after intervention
Timepoint
measuring patient's rate of change after session 5th and 10th sessions
Method of measurement
The Global Rating of Change (GRC):this scale is designed to assess the patient's level of change and wellness after intervention . if a patient marks a number between -1 to -5 indicates worsening of his/her condition. in contrast if someone say a number between +1 to +5 represent getting better.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: this group is going to recieve 2 methods of physical therapy including :exercise therapy(stretching and strengthing exercises) and self-release(treatment of trigger points and painful spots by using a tennis ball) via video call by common applications in smartphones (such as whatsapp or skype) and laptops for 3 weeks . it will be 10 sessions in this approach and patients will have 3 to 4 sessions every week in order to apply them on their own at home.
Category
Rehabilitation
2
Description
Intervention group 2: this group is going to recieve 2 methods of physical therapy including :exercise therapy(stretching and strengthing exercises) and self-release(treatment of trigger points and painful spots by using a tennis ball) via getting educational videos by common applications in smartphones and laptops for 3 weeks . it will be 10 sessions in this approach and patients will have 3 to 4 sessions every week in order to apply them on their own at home.
Category
Rehabilitation
3
Description
Control group: Intervention group 1: this group is going to recieve 2 methods of physical therapy including :exercise therapy and tissue release in physiotherapy clinic by therapist for 3 weeks . it will be 10 sessions in this approach and patients will have 3 to 4 sessions every week.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
physical therapy clinic of school of rehabilitation - Tehran university of medical science
Full name of responsible person
Fatemeh Ehtesami
Street address
Enghelab st , Shemiran turning
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7753 5132
Email
rehabilitation@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
khadije otadi
Street address
physical therapytherapy department, school of reabilitation , shemiran turning , enghelab st
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7753 3939
Email
k_otadi@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Ehteshami
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
aseman block, omid alley, meghdad alley,jaber ansari st
City
Isfahan
Province
Isfehan
Postal code
8138986860
Phone
+98 31 3436 9369
Email
fateme.ehteshami94@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
khadije otadi
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
physical therapy department, school of rehabilitation of the university of tehran , shemiran turning , enghelab st
City
tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
k_otadi@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
fatemeh ehteshami
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
aseman building , omid alley , meghdad alley , jaber ansari st , isfahan
City
isfahan
Province
Isfehan
Postal code
8138986860
Phone
+98 31 3436 9369
Email
fateme.ehteshami94@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