Low Level Laser Therapy Associated With Exercise in Subacromial Impingement Syndrome

NCT02725749 | Completed Phase 4

• 1 other identifier: USaoPauloGH1
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Subacromial Impingement Syndrome

Keywords

shoulder; low level laser therapy; exercises

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

Laser

EXPERIMENTAL

Radiation: Laser

Exercise

EXPERIMENTAL

Other: EXE

Laser and Exercise

EXPERIMENTAL

Radiation: Laser + EXE

Interventions

Laser RADIATION

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.

Laser

EXE OTHER

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.

Also known as: Exercise

Exercise

Laser + EXE RADIATION

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.

Also known as: Laser and Exercise

Laser and Exercise

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of subacromial impact syndrome
• Age range: 30-75 years
• Both genders

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Related Publications (1)

• 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.

  PMID: 33307783 DERIVED

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Motor Activity

Interventions

Lasers; Exercise

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries; Behavior

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: April 1, 2016
• Study Start: January 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 5, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share