Efficacy of High Intensity Lazer Therapy in Partial Supraspinatus Tear

Study Overview
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Brief Summary
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Rotatorcuff lesions constitute 10% of the causes of shoulder pain. Supraspinatus tear is one of the common rotatorcuff lesions. It affects the quality of life negatively and causes loss of range of motion and muscle strength. It can be seen due to traumatic or degenerative causes. Its incidence increases with advanced age. While the incidence was reported as 4% in the population aged 40-60 years, this rate was reported to be 17-50% in the group over the age of 60 and 80% in the group over the age of 80. Radiologically, classification is made as partial or full-thickness tears. Rotatorcuff tears can be treated conservatively or surgically. Although the risk of post-surgical rupture is reduced with new methods, the lack of desired tendon healing has led to the search for alternative applications such as biological augmentation and high-intensity laser. The aim of this study is to reveal the effectiveness of high-intensity laser therapy in patients with partial supraspinatus tear.

Detailed Description
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90 patients aged 20-60 years who were diagnosed with partial supraspinatus tear and met the inclusion criteria of the study will be included in the study. Patients will be randomized into three groups: 30 patients in the first group who have 5 sessions of high-intensity laser, 30 patients in the second group who have 10 sessions of high-intensity laser, and 30 patients in the third group control group who have only exercises. It was planned to give 5 sessions of laser+exercise every other day to the the first group, 10 sessions of laser+exercise every other day to the second group, and only exercise program three days in a week to the control group. All groups will be evaluated with joint range of motion (ROM) (measurements including abduction, adduction, flexion, extension, internal and external rotation by goniometer according to neutral 0 position), visual analog scale (VAS), shoulder pain dissability index, quickdash, constant score at 0th month, 1st month, 3rd and 6th months.

Official Title
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Efficacy of High Intensity Lazer Therapy in Patients Diagnosed With Partial Supraspinatus Tear

Conditions
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Supraspinatus Tear

Intervention / Treatment
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* Device: High-intensity lazer therapy
* Other: Exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 20-65 years Patients with VAS>4 pain in the shoulder for at least 3 months Patients with at least 25% loss in the range of motion of the joint compared to the contralateral side, especially in abduction and external rotation, or on physical examination or positivity of at least one of the impingement tests including jobb, lift off, ERLS , speed, yergeson, O Brien's test, dropparm tests or popeye signs. Diagnose of partial supraspinatus with ultrasound or MR Exclusion Criteria: Patients with incomplete skin integrity, hyperemia, signs of infection or tattoos Patients with suspected full-thickness tear History of rheumatic disease (rheumatoidarthritis, osteoarthritis, PMR) Patients with accompanying shoulder pathology such as calcifictendinitis History of malignancy Surgery, manipulation, mobilization, arthroscopy performed on the affected shoulder Steroid, local anesthetic, hyaluronic acid injection, cnesiotaping or neural therapy in the affected shoulder in the last 3 months Reflex sympathetic dystrophy, neurodeficit in the affected extremity Diabetes patients or any Patients who cannot feel the burning pain due to a peripheral neuropathy or sensory defect Patients with epilepsy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 5 session lazer therapy<br>30 patients will be included to 5 session lazer therapy group. They will take totally 5 sessions of high-intensity laser every other day. | Device: High-intensity lazer therapy<br>* Patients in the laser group will be given hiltherapy (high-intensity laser) with the HIRO 3 device every other day. One session of laser therapy application consists of 3 phases: the beginning, the middle and the ending phase. The initial phases are fast scanning and the ending phase is slow scanning. A total of 2000 J will be applied to the rotatorcuff muscles, the upper part of the trapezius muscle, the deltoid muscle and the pectoralis major muscle, 1000 J in the rapid scan phase and 1000 J in the finishing phase. In the middle phase, 50 J will be applied for the trigger point (hard intramuscular points that cause referred pain) in each muscle and a maximum of 500 J in total. The total dose prescribed for patients in one session will be 2500 J. Each phase will be 15 minutes on average and the session will last for 45 minutes in total. The laser probe will be applied with 90 degrees. During the application, the practitioner and the patient will have protective glasses.<br>|
| Active Comparator: 10 session lazer therapy<br>30 patients will be included to 10 session lazer therapy group. They will take totally 10 sessions of high-intensity laser every other day. | Device: High-intensity lazer therapy<br>* Patients in the laser group will be given hiltherapy (high-intensity laser) with the HIRO 3 device every other day. One session of laser therapy application consists of 3 phases: the beginning, the middle and the ending phase. The initial phases are fast scanning and the ending phase is slow scanning. A total of 2000 J will be applied to the rotatorcuff muscles, the upper part of the trapezius muscle, the deltoid muscle and the pectoralis major muscle, 1000 J in the rapid scan phase and 1000 J in the finishing phase. In the middle phase, 50 J will be applied for the trigger point (hard intramuscular points that cause referred pain) in each muscle and a maximum of 500 J in total. The total dose prescribed for patients in one session will be 2500 J. Each phase will be 15 minutes on average and the session will last for 45 minutes in total. The laser probe will be applied with 90 degrees. During the application, the practitioner and the patient will have protective glasses.<br>|
| Other: control group<br>30 patients will be included to control group. They will take only exercise program three times in a week. | Other: Exercises<br>* Exercise program including Codman, Range of motion and streightening exercises three times in a week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS (visuel analog score) | evaluation of pain with scale of between 0 and 10 that means 0 no pain and 10 too much pain. | 3rd month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant score | The Constant score (CS) is one of the most frequently applied tools for the assessment of the shoulder joint.The Constant score is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient | 6 th month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shoulder, supraspinatus tear, rotator cuff tear, hiltherapy, lazer therapy