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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
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subacromial Impingement Syndrome focused on measuring shoulder, low level laser therapy, exercises

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 21, 2016
    Last Updated
    April 2, 2016
    Sponsor
    University of Sao Paulo General Hospital
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    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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