Effects of High Intensity Laser Therapy (HILT) in Patients With Subacromial Impingement Syndrome

Study Overview
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Brief Summary
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The aim of this study is to determine the effects of high intensity laser therapy (HILT) in patients with subacromial impingement syndrome (SIS). This study aims to compare the effects of HILT alone and HILT and therapeutic exercise combination on shoulder pain, ROM, joint position sense (JPS), muscle strength and function.The investigators hypothesized that shoulder pain, ROM, JPS, muscle strength and functionality would improve with both treatments but that HILT combined with exercise would result in better outcomes than HILT alone.

Detailed Description
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30 patients with SIS will be randomized into two groups. Pain intensity will be assessed with visual analogue scale (VAS), pain-free and normal range of motion (ROM) with goniometer, joint position sense (JPS) with inclinometer, muscle strenght with hand-held dynamometer, and shoulder functionality with Constant Murley Score (CMS) and Shoulder Pain and Disability Index (SPADI) in a pretest-posttest design. HILT Group (n=15) will receive only HILT for 10 sessions, 3 days a week on alternate days. HILT& Exercise Group (n=15) will receive exercise treatment in addition to HILT for the same duration of time.

Official Title
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Effects of High Intensity Laser Therapy (HILT) in Patients With Subacromial Impingement Syndrome

Conditions
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Subacromial Impingement Syndrome

Intervention / Treatment
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* Device: HILT
* Combination Product: HILT & EXERCISE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed as SIS (≥3 positive of 5 impingement tests: Neer's sign, Hawkins and Kennedy, Empty Can, painful arc of abduction and external rotation resistance tests) No history of shoulder injury and/or shoulder symptoms requiring treatment other than SIS for the last 1 year Shoulder pain less than 7/10 of Visual Analogue Scale Being able to elevate the shoulder over 140 degrees Exclusion Criteria: History of upper extremity fracture, shoulder surgery Frozen shoulder Full-thickness rotator cuff (RC) tear Shoulder instability, systemic musculoskeletal disease Shoulder pain with cervical spine motion, Having any of the contraindications of HILT.

Ages Eligible for Study
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Minimum Age: 18 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: Our study is a parallel group randomised comparison trial comparing two interventions with a 1:1 ratio.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HILT Group<br>HILT Group (n=15) | Device: HILT<br>* HILT will be performed with BTL 6000 High Intensity Laser (London, UK) which is a therapeutic non-invasive neodymium: yttrium aluminum garnet laser that has a pulsating waveform and 1064 nm wavelength, 12 Watt maximum power and has the ability to penetrate 12 cm.<br>* Other names: BTL 6000 High Intensity Laser (London, UK);|
| Experimental: HILT & EXERCISE Group<br>HILT&Exercise Group (n=15) | Combination Product: HILT & EXERCISE<br>* HILT&Exercise group will receive exercise therapy right after they receive HILT. Both groups will receive treatment for 3 days a week, on alternate days and totally 10 sessions. Patients will be asked not to use analgesic medication throughout the treatment period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Evaluation:Visual Analogue Scale (VAS) | Rest and activity pain of the shoulder will be measured on a 10-cm VAS ranging from 0 (no pain) to 10 (worst pain imaginable). Higher scores mean worse outcome. | 4 weeks | 
| Shoulder Range of Motion Evaluation | Active and passive ROM will be evaluated with universal goniometer (Baseline®, Fabrication End Inc, New York, USA). | 4 weeks | 
| Pain-free Range of Motion Evaluation | Pain-free ROM will be assessed by measuring pain-free ROM for active shoulder elevation in scapular plane with universal goniometer. While sitting on a chair with back support, patients performed elevation with their thumbs pointing up. One degree below the angle where the patient first experienced pain was recorded. | 4 weeks | 
| Muscle Strength Evaluation | A hand-held dynamometer (HHD) (Power track II, J Tech, New York, USA) will be used to assess muscle strength. Before the evaluations test order will be randomized for lower trapezius (LT), middle trapezius (MT), upper trapezius (UT), serratus anterior (SA), supraspinatus (SupraSp), subscapularis (SubSc), infraspinatus&teres minor (IS&TM) muscles. | 4 weeks | 
| Shoulder Joint Position Sense (JPS) Evaluation | A bubble inclinometer (Baseline®, Fabrication End Inc, NewYork, USA) will be used to assess active shoulder JPS. The inclinometer will be attached to an elastic strip via a velcro-band and placed on proximal humerus for abduction and on wrist for rotations. Shoulder JPS in abduction direction will be evaluated while patient sitting on a chair without back support at the angle of 100°, 19 internal rotation (IR) and external rotation (ER); while patient lying supine, at the angles of 45° IR and 75° ER. | 4 weeks | 
| Shoulder Function and Disability Evaluation | The Turkish version of the Shoulder Pain and Disability Index (SPADI) will be used to evaluate shoulder disability level. Items in the index are presented on a numerical rating scale (0 indicates no pain/no difficulty, 10 indicates worst pain/most difficulty). Higher score indicates greater disability. The Turkish version of the Constant-Murley Shoulder Score (CMS) will be used to evaluate shoulder function. It is a 100-points-scale composed of pain (15 points), activities of daily living (ADL) (20 points), active ROM (40 points) and strenght (25 points) subgroups. The total score is classified as excellent (90-100), good (80-89), moderate (70-79) and weak (<70). | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subacromial impingement syndrome, High Intensity Laser Therapy, Laser Therapy, Shoulder Pain