The Comparision of kinesio taping & mobilisition on pain, rang of motion & shoulder disability in subacromial impingement syndrome in dialysis patients
The results of this study can be helpful to adopting an appropriate treatment for subacromial impingement syndrome in dialysis patients.
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on 40 patients. Random blocks method is used for randomization.
Settings and conduct
In this study, 40 dialysis patients with subacromial impingement syndrome will be randomly divided into two groups (n=20). The first group will receive caudal and anterior-posterior glenohumeral mobilization. In the second group, kinesiotype will be done for the deltoid and supraspinatus muscles in addition to mobilization. Study variables include: visual scale of pain (in general shoulder condition and during shoulder abduction), maximum range of motion during active shoulder abduction and shoulder functional disability using DASH questionnaire. All variables will be measured before and after 12 sessions of treatment (3 times weekly). Subjective variables (pain and questionnaire) will also be evaluated 10 days after the end of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: positive of at least one subacromial syndrome tests (Neer, Hawkins, painful arch)- dialysis more than 6 months- shoulder pain more than 2 months- anterior and anterior-external shoulder pain- age between 40 to 60 years
exclusion criteria: Corticosteroid injection in the last 3 months-
neck radiculopathy pain- history of trauma and shoulder fracture in the last 6 months- history of shoulder and breast surgery- positivity of TOS test- pregnancy- cancer kensiotape sensitivity- physiotherapy in the last 3 months- rheumatoid arthritis- Non-steroidal anti-inflammatory drugs medication
Intervention groups
1. mobilization
2. mobilization and kinsiotape
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091214002851N5
Registration date:2020-10-18, 1399/07/27
Registration timing:prospective
Last update:2020-10-18, 1399/07/27
Update count:0
Registration date
2020-10-18, 1399/07/27
Registrant information
Name
Mohammad Taghipour
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 4641
Email address
taghipour@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-05, 1399/09/15
Expected recruitment end date
2021-06-05, 1400/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparision of kinesio taping & mobilisition on pain, rang of motion & shoulder disability in subacromial impingement syndrome in dialysis patients
Public title
Conservative management of subacromial impingement syndrome in dialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
positive of at least one subacromial syndrome tests (Neer, Hawkins, painful arc)
dialysis more than 6 months
shoulder pain more than 2 months
anterior and anterior-lateral shoulder pain
age between 40 to 60 years
Exclusion criteria:
Corticosteroid injection in the last 3 months
neck radiculopathy pain
history of trauma and shoulder fracture in the last 6 months
history of shoulder and breast surgery
positivity of TOS test
pregnancy
cancer
kensiotape sensitivity
physiotherapy in the last 3 months
rheumatoid arthritis
Non-steroidal anti-inflammatory drugs medication
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The participants of this study are dialysis patients with subacromial impingement syndrome who referred to Shahid Beheshti Hospital of Babol by an orthopedic specialist. About 40 patients participate in this study during 6 months according to the inclusion criteria and divide to the 10 randomized block (size of blocks: 4).
Patients in the first group (n = 20) receive mobilization treatment and in the second group (n = 20) receive mobilization treatment in addition to kinesiotape.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the examiner, therapist and statistical analyzer will be blind to grouping and intervention. Therefore, this study is a double-blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Babol University Of medical science, GanjAfrooz Street, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Approval date
2020-09-26, 1399/07/05
Ethics committee reference number
IR.MUBABOL.REC.1399.297
Health conditions studied
1
Description of health condition studied
Subacromial impingement syndrome in dialysis patients
ICD-10 code
M75.4
ICD-10 code description
Impingement syndrome of shoulder
Primary outcomes
1
Description
pain intensity
Timepoint
Before the intervention, one month after the starting of the intervention and 10 days after the end of the intervention
Method of measurement
visual analog scale
Secondary outcomes
1
Description
active ROM of shoulder
Timepoint
Before the intervention, one month after the starting of the intervention
Method of measurement
goniometer
2
Description
pain intensity and functional disability of shoulder
Timepoint
Before the intervention, one month after the starting of the intervention and 10 days after the end of the intervention
Method of measurement
DASH Questioner
Intervention groups
1
Description
Intervention group: mobilization and kinsiotape
Category
Rehabilitation
2
Description
Control group: mobilization
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Mohammad Taghipour
Street address
Keshvari Square, Sargord Ghasemi Ave., Shahid Beheshti hospital, Physiotherapy Center
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3226 0458
Fax
+98 11 3225 1664
Email
beheshti@mubabol.ac.ir
Web page address
http://beheshti.mubabol.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Reza Ghadimi
Street address
Babol University Of medical science, GanjAfrooz Street, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 7667
Fax
+98 11 3219 7667
Email
research@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
mona ramezani
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Facuality- Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
47745-47176
Phone
+98 11 3219 4641
Email
ramzanimona@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Mohammad Taghipour
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Facuality, Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
47745-47176
Phone
098 1132194641
Email
taghipour@mubabol.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mona Ramezani
Position
University Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Facuality, Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
47745-47176
Phone
+98 11 3219 4641
Email
ramzanimona@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
Access period starts 2 months after the results are published
To whom data/document is available
Researchers working in academic, scientific and medical institutions
Under which criteria data/document could be used
To cited by other researchers from the results of our research
From where data/document is obtainable
Dr. Mohammad Taghipour, Faculty of Rahabilitation, Babol University of Medical Sciences, taghipour@mubabol.ac.ir، 00989126899352
Mona Ramezani, Faculty of Rahabilitation, Babol University of Medical Sciences, ramzanimona@yahoo.com، 00989019849766
What processes are involved for a request to access data/document