Protocol summary
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Study aim
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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
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Design
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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
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Settings and conduct
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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
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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High power laser group، Low power laser group، control group
In all three groups, Kinesiotape will be used
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Main outcome variables
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Pain، shoulder function، sonography parameters of subacromial space
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180406039203N1
Registration date:
2018-06-03, 1397/03/13
Registration timing:
prospective
Last update:
2020-01-14, 1398/10/24
Update count:
1
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Registration date
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2018-06-03, 1397/03/13
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-05-21, 1397/02/31
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Expected recruitment end date
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2018-10-21, 1397/07/29
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Actual recruitment start date
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2018-06-08, 1397/03/18
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Actual recruitment end date
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2018-11-06, 1397/08/15
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Trial completion date
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2018-11-22, 1397/09/01
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Scientific title
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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
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Public title
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Evaluation of high power and low power laser with tape and in shoulder impingement
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 40 years old to 60 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
37
Actual sample size reached:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple and individual randomization will be done through sealed envelopes
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Individuals participating in the study are blind to what kind of laser they receive or are in the control group
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Precise assessment of changes before and after treatment with ultrasound
Ethics committees
1
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Ethics committee
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Approval date
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2018-05-28, 1397/03/07
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Ethics committee reference number
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IR.MODARES.REC.1397.005
Health conditions studied
1
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Description of health condition studied
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Subacromial impingement syndrome
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ICD-10 code
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M75.41
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ICD-10 code description
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Impingement syndrome of right shoulder
Primary outcomes
1
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Description
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Pain
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Timepoint
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Before and after treatmant
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Method of measurement
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Visual analogue scale
Secondary outcomes
1
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Description
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Range of motion
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Timepoint
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Before and after treatmant
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Method of measurement
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Goniometer
Intervention groups
1
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Description
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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
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Category
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Treatment - Devices
2
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Description
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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.
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Category
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Treatment - Devices
3
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Description
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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
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Category
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Treatment - Devices
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tarbiat modares university
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Unidentifiable people can share all the data
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When the data will become available and for how long
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Start the access period 6 months after printing the results
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To whom data/document is available
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Data will be available to researchers working in academic and scientific institutes in the industry
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Under which criteria data/document could be used
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To carry out scientific projects
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From where data/document is obtainable
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zohre zaki , zaki_zohre@yahoo.com
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What processes are involved for a request to access data/document
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Submitting the project plan and the full review of the individuals and the organization carrying out the project and will be sent upon confirmation
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Comments
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