Low Level Laser Therapy Associated With Exercise in Subacromial Impingement Syndrome

Study Overview
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Brief Summary
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Objectives: The objective was to compare low level laser therapy (LLLT) therapy versus low LLLT therapy in combination with an exercise or exercise only on pain, range of motion (ROM), functionality, and activity limitation in patients with subacromial impact syndrome. Design: Randomized and placebo-controlled clinical trial. Setting: The setting for the study was the Municipal Clinic of Barueri, São Paulo, Brazil. Participants: 60 patients with subacromial impact syndrome were randomly assigned in three groups. Interventions: Group I, experimental (n=21) treated with low level laser therapy and exercises; Group II, experimental (n=21) treated with exercises; and Group III, experimental (n=18) treated with low level laser therapy. Laser used were GaAs (904 nm, 60 mW), in continuous emission. The participants received application of laser three times or week for eight weeks, on 9 shoulder points (3 Joules/point) per session. Main outcome measures: Visual Analogic Scale (VAS) score, Shoulder Pain and Disability Index (SPADI), goniometer, Modified-University of California at Los Angeles Shoulder Rating Scale (UCLA), recorded before and after treatment.

Detailed Description
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In the groups that received low level laser therapy (LLLT), energy was irradiated over three insertion points in the supraspinatus muscle region, three points on the bursa subacromial, and three points along the bicipital groove, at 3 Joules per point. Total dose per shoulder was 27 Joules per treatment, using a previously calibrated Irradia Class 3B (Stockholm, Sweden). Pen's semiconductor consisted of gallium arsenide with a wavelength of 904 nm, frequency of 700 Hz, average potency of 60 mW, peak potency of 20 W, pulse duration of 4.3 ms, and 50 seconds per point (0.5cm2 area). The parameters followed the recommendation of the World Association of Laser Therapy for subacromial impact syndrome. The participants received application of laser three times or week for eight weeks. The groups treated with exercise followed the same training program. Isotonic strengthening exercises were performed for the scapular pivot, scapula stabilizer, and humeral propellant muscle groups. Three sets of 15 repetitions of each isotonic strengthening exercise were performed. The isometric exercises were performed in ten sets of ten seconds each. Analytical stretching of each muscle group was performed at the beginning of the session for 30 seconds. The participants performed the exercises three times a week for eight weeks.

Official Title
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Effect of Low Level Laser Therapy Associated With Exercise in Subacromial Impingement Syndrome: a Randomized, Double-blind Study

Conditions
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Subacromial Impingement Syndrome

Intervention / Treatment
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* Radiation: Laser
* Other: EXE
* Radiation: Laser + EXE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of subacromial impact syndrome Age range: 30-75 years Both genders Exclusion Criteria: cancer, diabetes, symptomatic shoulder osteoarthritis, surgery or previous fractures in the humeral head of the shoulder, history of acute trauma, calcification of the articular rotator tendon, total tendon rupture, cervical myofascial syndrome, radicular pain, inflammatory rheumatic disease, neurological disorders, depressive syndrome use of antidepressants, use of anti-inflammatory medications use anxiolytics

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser<br> | Radiation: Laser<br>* Laser used were GaAs (904 nm, 60 mW), in continuous emission. The participants received application of laser three times or week for eight weeks, on 9 shoulder points (3 Joules/point) per session.<br>|
| Experimental: Exercise<br> | Other: EXE<br>* Isotonic strengthening exercises were performed for the scapular pivot, scapula stabilizer, and humeral propellant muscle groups. Three sets of 15 repetitions of each isotonic strengthening exercise were performed. The isometric exercises were performed in ten sets of ten seconds each. Analytical stretching of each muscle group was performed at the beginning of the session for 30 seconds. The participants performed the exercises three times a week for eight weeks.<br>* Other names: Exercise;|
| Experimental: Laser and Exercise<br> | Radiation: Laser + EXE<br>* Laser used were GaAs (904 nm, 60 mW), in continuous emission. The participants received application of laser three times or week for eight weeks, on 9 shoulder points (3 Joules/point) per session. Isotonic strengthening exercises were performed for the scapular pivot, scapula stabilizer, and humeral propellant muscle groups. Three sets of 15 repetitions of each isotonic strengthening exercise were performed. The isometric exercises were performed in ten sets of ten seconds each. Analytical stretching of each muscle group was performed at the beginning of the session for 30 seconds. The participants performed the exercises three times a week for eight weeks.<br>* Other names: Laser and Exercise;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessed using a VAS | Pain was assessed using a VAS consisting of a 10cm ruler (without numbers), ranging from no pain on the left side to unbearable pain on the right side. The patients were instructed to mark their level of pain on the ruler. | 1 year | 
| Range of motion assessed with a universal goniometer (Aesculap) | Range of motion was assessed with a universal goniometer (Aesculap) used to measure shoulder flexion and extension according to the methods described by Marques et al. (2011). | 1 year | 
| Functionality measured using the Modified-University of California at Los Angeles Shoulder Rating Scale | Functionality was measured using the Modified-University of California at Los Angeles Shoulder Rating Scale, which consists of five domains-pain, function, range of motion, muscle strength, and patient satisfaction-and a possible total of 35 points, with higher scores indicating better results | 1 year | 
| Quality of life assessed with the Shoulder Pain and Disability Index (SPADI) | Quality of life was assessed with the Shoulder Pain and Disability Index (SPADI). This questionnaire, which is specific to the shoulder joint, assesses pain and disability. The SPADI consists of 13 items distributed in the areas of pain (five items) and function (eight items), with each item scored on a numerical scale from 0 to 10 points. The final score of the questionnaire and the score of each domain are converted into percentages ranging from 0 to 100%, with higher scores indicating worse shoulder conditions | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shoulder, low level laser therapy, exercises