Low Level Laser Therapy Associated With Exercise in Subacromial Impingement Syndrome

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

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.

Study Overview

• Status: Completed
• Conditions: Subacromial Impingement Syndrome
• Intervention / Treatment: Radiation: Laser; Other: EXE; Radiation: Laser + EXE

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise	Other: EXE; 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.; Other Names: Exercise
Experimental: Laser	Radiation: Laser; 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.
Experimental: Laser and Exercise	Radiation: Laser + EXE; 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.; Other Names: Laser and Exercise

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital

Publications and helpful links

General Publications

• Alfredo PP, Bjordal JM, Junior WS, Marques AP, Casarotto RA. Efficacy of low-level laser therapy combined with exercise for subacromial impingement syndrome: A randomised controlled trial. Clin Rehabil. 2021 Jun;35(6):851-860. doi: 10.1177/0269215520980984. Epub 2020 Dec 14.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: March 21, 2016
• First Submitted That Met QC Criteria: March 31, 2016
• First Posted (Estimate): April 1, 2016

Study Record Updates

• Last Update Posted (Estimate): April 5, 2016
• Last Update Submitted That Met QC Criteria: April 2, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: shoulder; low level laser therapy; exercises
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Joint Diseases; Musculoskeletal Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Syndrome; Rotator Cuff Injuries; Shoulder Impingement Syndrome
• Other Study ID Numbers: USaoPauloGH1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No