Evaluation of the Effects of High-Power Laser and Exercise Therapy on Supraspinatus Tendon Tear and Glenohumeral Joint Kinetics and Kinematics: Randomized Clinical Trial
Investigating the effect of high-power laser and exercise therapy on supraspinatus tendon tear and glenohumeral joint kinetics and kinematics
Design
This study is a single-blind randomized controlled clinical trial. The study will be conducted on two treatment and control groups of women and men, each group will include 14 people, with incomplete rupture of the supraspinatus tendon diagnosed by an orthopedic doctor and in the age range of 40-60 years. A group of 14 healthy people will also be evaluated to compare the parameters with the normal state.
Settings and conduct
This study will be done in Tarbiat Modares University in tehran and sampling will be done in the Orthopedic Clinic of Shafa Yahyayan Hospital in tehran. All evaluations, including ultrasound, electromyography, movement analysis, which are performed before and 48 hours after the last treatment session, will be done by an examiner who is blind to the grouping. Treatment in both treatment and sham groups will be done 10 sessions and 3 times a week.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1-3 cm tear in the supraspinatus tendon
Age between 40-60 years
Exclusion criteria:
• Tears in other components of the rotator cuff with or without supraspinatus injury
• Injury caused by exercise
Intervention groups
10 sessions of high-power laser therapy and exercise therapy and placebo laser and exercise therapy in Sham group
Main outcome variables
Strength of muscle groups, pain, Shoulder pain and disability index questionnaire, ultrasound evaluation, evaluation of muscle activity pattern, kinetic and kinematic variables will be done during the examination up to 80 degrees.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180406039203N2
Registration date:2024-01-28, 1402/11/08
Registration timing:prospective
Last update:2024-01-28, 1402/11/08
Update count:1
Registration date
2024-01-28, 1402/11/08
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
2024-02-19, 1402/11/30
Expected recruitment end date
2025-06-20, 1404/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effects of High-Power Laser and Exercise Therapy on Supraspinatus Tendon Tear and Glenohumeral Joint Kinetics and Kinematics: Randomized Clinical Trial
Public title
The effect of high-power laser on supraspinatus tendon tear
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range: 40-60 years
Body mass index 25-30
The presence of an incomplete tear of 1-3 cm in the supraspinatus according to MRI
The positiveness of Drop Arm tests: empty can test, external rotation delay sign, champagne toast
Having reading and writing literacy at the cycle level
Moderate pain intensity based on Visual analogue scale 35-74 mm
Arm circumference size cm 1.28-4.29
Exclusion criteria:
The unwillingness of people to continue treatment for any reason
Tears in other components of the rotator cuff with or without supraspinatus injury
Use of non-steroidal and steroidal anti-inflammatory drugs
Injection in the shoulder in 3 months before the study
Receiving physiotherapy treatments in 3 months before the study
Damage caused by exercise
The existence of a neurological disease that leads to muscle weakness or reduced range of motion
History of systemic diseases such as: rheumatoid arthritis, diabetes, severe cardiovascular disease, history of shoulder surgery
Presence of any shoulder pathology that leads to shoulder kinematic change
Contraindications for laser use: pregnancy, epilepsy, pacemaker, cancer
Dissemination of pain from the neck
More than 12 months have passed since the onset of their symptoms
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Web-based randomization and masking through sealed envelopes will be used. First, the website http://www.graphpad.com/quickcalcs/index.cfm3 will be used to create a random sequence. Sealed opaque envelopes are used to hide the random allocation. Envelopes with aluminum wrappers (in order to make the contents of the envelopes unclear), preparation and each of the randomly created sequences are recorded on a card and the cards are placed inside the envelopes in order. Finally, the envelope door The letters are glued and placed in a box in order. At the time of registration of the participants, based on the order of entry of eligible participants into the study, one of the envelopes will be opened and the assigned group of that participant will be revealed.
Blinding (investigator's opinion)
Single blinded
Blinding description
Data collection will be done by an experimenter who is not aware of the grouping.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tarbiat Modares University
Street address
Jalal Al Ahmad
City
Tehran
Province
Tehran
Postal code
14115-111
Approval date
2023-10-22, 1402/07/30
Ethics committee reference number
IR.MODARES.REC.1402.122
Health conditions studied
1
Description of health condition studied
Supraspinatus tendon partial thickness tear
ICD-10 code
M75.1
ICD-10 code description
Rotator cuff tear or rupture, not specified as traumatic
Primary outcomes
1
Description
Supraspinatus tendon tear size
Timepoint
Before and 48 hours after end of treatment
Method of measurement
The tear size is measured by ultrasound
2
Description
glenohumeral superior translation
Timepoint
Before and 48 hours after end of treatment
Method of measurement
Superior translation of the humeral head is measured by the motion analysis system.
Secondary outcomes
1
Description
pain
Timepoint
pre and 48 hours post treatment
Method of measurement
By visual analogue scale
2
Description
muscle groups strength
Timepoint
pre and 48 hours post treatment
Method of measurement
By hand held dynamometer
3
Description
pain and function
Timepoint
pre and 48 hours post treatment
Method of measurement
By shoulder and pain disability index
4
Description
EMG activity pattern, Root mean square
Timepoint
pre and 48 hours post treatment
Method of measurement
by electromyography system
5
Description
scapulohumeral rhythm
Timepoint
pre and 48 hours post treatment
Method of measurement
by motion analysis system
6
Description
angular speed
Timepoint
pre and 48 hours post treatment
Method of measurement
by motion analysis system
7
Description
angular acceleration
Timepoint
pre and 48 hours post treatment
Method of measurement
by motion analysis system
8
Description
torque
Timepoint
pre and 48 hours post treatment
Method of measurement
by motion analysis system
Intervention groups
1
Description
Intervention group: K-laser will be used in this study. The treatment will be done 3 times a week for 10 sessions. In the first 3 sessions, the total energy will be 2478 joules, the average power will be 9 watts and the maximum power will be 20 watts. In the last 7 sessions, the total energy will be 4678 joules.
Category
Rehabilitation
2
Description
Control group: The treatment will be done 3 times a week for 10 sessions. Lasers are off in all meetings.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa yahyaian Hospital
Full name of responsible person
Morteza Nakhaei Amroodi
Street address
Mojahedin Eslam
City
Tehran
Province
Tehran
Postal code
371311576
Phone
+98 21 3354 2001
Email
zakizohre69@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Roya Ravanbod
Street address
Jalal Al Ahmad
City
tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 82880
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
Zohreh Zaki
Position
Ph.D. candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Jalal Al Ahmad
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 82880
Email
zakizohre69@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat modares university
Full name of responsible person
Roya Ravanbod
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tarbiat modares university Jalal Ale Ahmad street , Tehran
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3595
Fax
Email
rravanbod@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat modares university
Full name of responsible person
Zohre Zaki
Position
Ph.D. candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Tarbiat modares university Jalal Ale Ahmad street , Tehran
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3595
Fax
Email
zaki_zohre@yahoo.com
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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available