Evaluation and comparison of two therapeutic physiotherapy protocols of high power or low power lasers combined with kinesio taping on shoulder function and musculoskeletal sonography parameters in patients with subacromial impingement syndrome
Evaluation and comparison of two therapeutic physiotherapy protocols of high power or low power lasers combined with kinesio taping on shoulder function and musculoskeletal sonography parameters in patients with subacromial impingement syndrome
Design
Clincal Trial , randomised with concealed envelope and with control group
There are three groups, and 10 in each group are calculated based on previous studies
Settings and conduct
The intervention will be three sessions per week and seven sessions
Assessment is performed before and after treatment
There are two treatment groups and one control group. Patients are not aware of the type of intervention
Participants/Inclusion and exclusion criteria
Women and men with subacromial impingement syndrome
40-60 years old
Right shoulder pain , BMI 25-30
Stage I , II in Neer classification
The presence of tendonitis and inflammation in the MRI that is being examined by a doctor
Painful arch 40-120 of shoulder abduction
Positive Neer , Hawkins-kennedy and Yocum tests
VAS 4-8
exclusion criteria:
presence of : pregnancy , shoulder surgery , GH joint dislocation , corticosrteoid or heyaloronic acid injection
presence of : frozen shoulder ، Acromioclavicular joint arthritis ، Rottator cuff rupture , shoulder instability
osteoprosis
Distracting the neck and changing the symptoms with neck movements
Use anti-inflammatory and anti-inflammatory drugs since the onset of evaluation and participation in the study
Unwillingness to continue treatment for any reason
Intervention groups
High power laser group، Low power laser group، control group
In all three groups, Kinesiotape will be used
Main outcome variables
Pain، shoulder function، sonography parameters of subacromial space
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180406039203N1
Registration date:2018-06-03, 1397/03/13
Registration timing:registered_while_recruiting
Last update:2018-06-03, 1397/03/13
Update count:1
Registration date
2018-06-03, 1397/03/13
Registrant information
Name
Zohre Zaki
Name of organization / entity
Tarbiat modares university
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 3595
Email address
zohre_zaki@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-21, 1397/02/31
Expected recruitment end date
2018-10-21, 1397/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of two therapeutic physiotherapy protocols of high power or low power lasers combined with kinesio taping on shoulder function and musculoskeletal sonography parameters in patients with subacromial impingement syndrome
Public title
Evaluation of high power and low power laser with tape and in shoulder impingement
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
BMI 25-30 , Right shoulder pain
Stage I,II in Neer Classification
The presence of tendonitis and inflammation in the MRI that is being examined by a doctor
Painful arch 40-120 of shoulder abduction
Positive Yocum , Neer and Hawkins - kennedy tests
Weakness or pain in resistence external rotation , internal rotation and abduction
VAS 4-8
Exclusion criteria:
Presence : pregnancy , shoulder surgery , G.H joint dislocation , corticostroid and heyaloronic acid injection from 6 month befor
Presence: Frozen shoulder ، Acromioclavicular joint arthritis , Rottator cuff ruptur , shoulder instability
Tscore lower than -2
Radicular pain
Use anti-inflammatory and drugs since the onset of evaluation and participation in the study
Unwillingness to continue treatment for any reason
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
37
Randomization (investigator's opinion)
Randomized
Randomization description
Simple and individual randomization will be done through sealed envelopes
Blinding (investigator's opinion)
Single blinded
Blinding description
Individuals participating in the study are blind to what kind of laser they receive or are in the control group
Placebo
Used
Assignment
Parallel
Other design features
Precise assessment of changes before and after treatment with ultrasound
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Ethics Committee for Biomedical Research
Street address
Jala al ahmad street , Tarbiat modares university
City
Tehran
Province
Tehran
Postal code
14115-111
Approval date
2018-05-28, 1397/03/07
Ethics committee reference number
IR.MODARES.REC.1397.005
Health conditions studied
1
Description of health condition studied
Subacromial impingement syndrome
ICD-10 code
M75.41
ICD-10 code description
Impingement syndrome of right shoulder
Primary outcomes
1
Description
Pain
Timepoint
Before and after treatmant
Method of measurement
Visual analogue scale
Secondary outcomes
1
Description
Range of motion
Timepoint
Before and after treatmant
Method of measurement
Goniometer
Intervention groups
1
Description
Intervention group: A high power laser with a power of 4 watts for 9 minutes will be used on a sub-acromicl space of 10 centimeters in area, and the total energy received will be 2050 jul. Per square centimeter. Treatment will be performed three times a week for seven sessions
Category
Treatment - Devices
2
Description
Intervention group: A low power laser with a power of 200 MW for 16 minutes will be used on a sub-acromicl space of 10 cm2. The total energy received will be 200 jules per square centimeter. Treatment is performed three times a week for seven sessions.
Category
Treatment - Devices
3
Description
Control group: A placebo laser will be given for 10 minutes. The patient's position and therapist will be treated in the same way as the treatment group. The device is switched on and the radiation does not start
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr.ravanbod physiotherapy clinic
Full name of responsible person
Roya Ravanbod
Street address
Number4 ,Tarabande alley , Valiasr street
City
Tehran
Province
Tehran
Postal code
3153894139
Phone
+98 21 8608 5935
Email
zaki_zohre@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat modares university
Full name of responsible person
Roya Ravanbod
Street address
Jalal Ale Ahmad street , Tarbiat modares university
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 0000
Email
zaki_zohre@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat modares university
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
Tarbiat modares university
Full name of responsible person
Zohre Zaki
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Jala Ale Ahmad street , Tarbiat modares university
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 0000
Email
zaki_zohre@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat modares university
Full name of responsible person
Zohre Zaki
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Jalal Ale Ahmad street , Tarbiat modares university
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 0000
Email
zaki_zohre@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat modares university
Full name of responsible person
Zohre Zaki
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Jalal Ale Ahmad steet , Tarbiat modares university
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 0000
Email
zaki_zohre@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
Unidentifiable people can share all the data
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Data will be available to researchers working in academic and scientific institutes in the industry
Under which criteria data/document could be used
To carry out scientific projects
From where data/document is obtainable
zohre zaki , zaki_zohre@yahoo.com
What processes are involved for a request to access data/document
Submitting the project plan and the full review of the individuals and the organization carrying out the project and will be sent upon confirmation