High and Low Laser for Subacromial Impingement Syndrome

January 21, 2023 updated by: Marwa Shafiek Mustafa Saleh, Cairo University

High Intensity Versus Low Level Laser Therapy in Treatment of Patients With Subacromial Impingement Syndrome: A Randomized, Double-blind, Controlled Trial.

Shoulder pain is the third most common musculoskeletal problem after lumbar and neck diseases in clinical practice, and the most common cause of shoulder pain is subacromial impingement syndrome. The main goal of treatment is to reduce pain and to solve the mechanical problem that causes functional impairment. Low-level laser treatment is an increasingly used treatment modality in the treatment of subacromial impingement syndrome as in many musculoskeletal diseases, as it promotes cell proliferation and tissue regeneration by its anti-inflammatory and photobiostimulation properties. Also, High-intensity laser therapy is a treatment method that is gaining popularity in the recent years. These ultra-short impulses effect a deep action in the biological tissue (3-4 cm), with a homogeneous distribution of the light source in the irradiated soft tissue, but without excessive thermal enhancements. It reduces pain and edema with photomechanic effects in deep tissues. As far as the investigators know, there are no studies comparing these two treatment modalities in subacromial impingement syndrome yet. This study was planned to compare the efficacy of High-intensity laser therapy and low-intensity laser therapy in treatment of patients with subacromial impingement syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt, 12613
        • Faculty of Physical Therapy, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • shoulder pain for at least one month
  • male and female patients with age range from 25-45 years old
  • positive impingement test results
  • stage I or II disease according to the Neer classification, confirmed by MRI
  • visual analog scale score greater than 40 mm.

Exclusion Criteria:

patients will be excluded if they have:

  • major trauma to the shoulder
  • stage III subacromial impingement syndrome
  • diabetes mellitus
  • hypothyroidism
  • calcific tendinitis
  • adhesive capsulitis (forward flexion less than 160, horizontal abduction less than 160
  • installation of cardiac pacemaker
  • history of a physical therapy program for the same shoulder in the last 6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: control group
Other: traditional physical therapy exercises
Also the patients will receive traditional physical therapy exercises in the form of flexibility and strengthening exercises for shoulder muscles.
Experimental: High laser group
Other: high intensity laser in addition to traditional physical therapy exercises

high intensity laser will be used with 1064 nm wavelength and maximum of 25 W power. Analgesic and biostimulant modes were used in the present study.

Also the patients will receive traditional physical therapy exercises in the form of flexibility and strengthening exercises for shoulder muscles.
Experimental: low laser group
Other: low level laser in addition to traditional physical therapy exercises

patients will receive low level Laser Therapy in addition to traditional physical therapy exercises.

diode laser device with a wavelength of 850nm, power output of 100mV, continuous wave and 0.07cm2 spot area laser will be used. The laser will be applied with a dosage of 5 joule/cm2 (totally 15-20 joule) at the most 5 painful points for 1 minute at each point over subacromial region of the shoulder.

Also the patients will receive traditional physical therapy exercises in the form of flexibility and strengthening exercises for shoulder muscles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain intensity
Time Frame: change from base line at three weeks
Pain will be evaluated by a visual analogue scale (VAS). The patient will be asked to mark the severity of pain on a 100-mm line with "no pain" on one end and "most unbearable pain" on the other end
change from base line at three weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
shoulder range of motion
Time Frame: change from baseline at three weeks
Flexion, abduction, and external rotation will be measured by using goniometer in a supine position and the active movements will be recorded. The goniometer will be centered at the acromion for abduction, greater tubercle for flexion, and olecranon for external rotation at 90° shoulder and elbow flexion
change from baseline at three weeks
pain pressure threshold
Time Frame: change from baseline at three weeks
Pressure Pain Threshold will be determined with an analogue algometer at the most painful point of the subacromial area. This point will be determined by a previous examination based on the point that the patient determined as 'his or her point of maximum pain'.
change from baseline at three weeks
Shoulder Pain and Disability Index
Time Frame: change from baseline at three weeks
this scale will be used to assess functional status of the shoulder. The SPADI includes shoulder questions and consists of two subscales: pain and disability. Pain subscale consists of 5 items, and disability subscale consists of 8 items, and the total score is 0-100
change from baseline at three weeks
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: change from baseline at three weeks
This scale assesses sleep quality and disorder and consists of seven subcomponents (subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, drug use, and daytime functions) and 19 items. Each component is evaluated on a score of 0-3 and is evaluated with a total sleep score ranging from 0 to 21, and high scores represent low sleep quality. A PSQI total score < 5 points is considered "good" sleep quality and > 5 points is "bad" sleep quality.
change from baseline at three weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2021

Primary Completion (Actual)

August 15, 2022

Study Completion (Actual)

September 15, 2022

Study Registration Dates

First Submitted

March 2, 2021

First Submitted That Met QC Criteria

March 2, 2021

First Posted (Actual)

March 5, 2021

Study Record Updates

Last Update Posted (Actual)

January 25, 2023

Last Update Submitted That Met QC Criteria

January 21, 2023

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Laser and impingement syndrome

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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