Low Level Laser Therapy Associated With Exercise in Subacromial Impingement Syndrome
Primary Purpose
Subacromial Impingement Syndrome
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Laser
EXE
Laser + EXE
Sponsored by
About this trial
This is an interventional treatment trial for Subacromial Impingement Syndrome focused on measuring shoulder, low level laser therapy, exercises
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Laser
Exercise
Laser and Exercise
Arm Description
Outcomes
Primary Outcome Measures
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.
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).
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02725749
First Posted
March 21, 2016
Last Updated
April 2, 2016
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02725749
Brief Title
Low Level Laser Therapy Associated With Exercise in Subacromial Impingement Syndrome
Official Title
Effect of Low Level Laser Therapy Associated With Exercise in Subacromial Impingement Syndrome: a Randomized, Double-blind Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Impingement Syndrome
Keywords
shoulder, low level laser therapy, exercises
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laser
Arm Type
Experimental
Arm Title
Exercise
Arm Type
Experimental
Arm Title
Laser and Exercise
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Laser
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
EXE
Other Intervention Name(s)
Exercise
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Laser + EXE
Other Intervention Name(s)
Laser and Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain assessed using a VAS
Description
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.
Time Frame
1 year
Title
Range of motion assessed with a universal goniometer (Aesculap)
Description
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).
Time Frame
1 year
Title
Functionality measured using the Modified-University of California at Los Angeles Shoulder Rating Scale
Description
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
Time Frame
1 year
Title
Quality of life assessed with the Shoulder Pain and Disability Index (SPADI)
Description
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
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33307783
Citation
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.
Results Reference
derived
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Low Level Laser Therapy Associated With Exercise in Subacromial Impingement Syndrome
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