Protocol summary
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Study aim
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Investigating the effect of high-power laser and exercise therapy on supraspinatus tendon tear and glenohumeral joint kinetics and kinematics
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Design
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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 23people, with incomplete rupture of the supraspinatus tendon diagnosed by an orthopedic doctor and in the age range of 40-60 years. A group of 23 healthy people will also be evaluated to compare the parameters with the normal state.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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10 sessions of high-power laser therapy and exercise therapy and placebo laser and exercise therapy in Sham group, and healthy group
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Main outcome variables
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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
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Reason for update
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Providing additional information
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180406039203N2
Registration date:
2024-01-28, 1402/11/08
Registration timing:
prospective
Last update:
2026-07-04, 1405/04/13
Update count:
1
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Registration date
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2024-01-28, 1402/11/08
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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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2024-02-19, 1402/11/30
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Expected recruitment end date
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2025-06-20, 1404/03/30
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Actual recruitment start date
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2024-02-19, 1402/11/30
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Actual recruitment end date
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2025-05-20, 1404/02/30
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Trial completion date
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2025-07-13, 1404/04/22
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Scientific title
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Evaluation of the Effects of High-Power Laser and Exercise Therapy on Supraspinatus Tendon Tear and Glenohumeral Joint Kinetics and Kinematics: Randomized Clinical Trial
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Public title
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The effect of high-power laser on supraspinatus tendon tear
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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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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- Participant
- Outcome assessor
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Sample size
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Target sample size:
28
Actual sample size reached:
69
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Data collection will be done by an experimenter who is not aware of the grouping.The participants were also blinded to the intervention groups.
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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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Ethics committees
1
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Ethics committee
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Approval date
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2023-10-22, 1402/07/30
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Ethics committee reference number
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IR.MODARES.REC.1402.122
Health conditions studied
1
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Description of health condition studied
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Supraspinatus tendon partial thickness tear
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ICD-10 code
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M75.1
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ICD-10 code description
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Rotator cuff tear or rupture, not specified as traumatic
Primary outcomes
1
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Description
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Supraspinatus tendon tear size
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Timepoint
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Before and 48 hours after end of treatment
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Method of measurement
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The tear size is measured by ultrasound
2
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Description
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glenohumeral superior translation
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Timepoint
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Before and 48 hours after end of treatment
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Method of measurement
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Superior translation of the humeral head is measured by the motion analysis system.
Secondary outcomes
1
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Description
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pain
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Timepoint
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pre-treatment, before 5th session and 48 hours post treatment
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Method of measurement
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By visual analogue scale
2
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Description
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muscle groups strength
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Timepoint
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pre and 48 hours post treatment
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Method of measurement
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By hand held dynamometer
3
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Description
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pain and function
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Timepoint
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pre and 48 hours post treatment
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Method of measurement
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By shoulder and pain disability index
4
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Description
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EMG activity pattern, Root mean square
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Timepoint
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pre and 48 hours post treatment
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Method of measurement
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by electromyography system
5
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Description
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angular speed
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Timepoint
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pre and 48 hours post treatment
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Method of measurement
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by motion analysis system
6
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Description
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angular acceleration
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Timepoint
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pre and 48 hours post treatment
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Method of measurement
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by motion analysis system
7
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Description
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torque
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Timepoint
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pre and 48 hours post treatment
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Method of measurement
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by motion analysis system
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
2
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Description
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Control group: The treatment will be done 3 times a week for 10 sessions. Lasers are off in all meetings.
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Category
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Rehabilitation
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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available