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High and Low Laser for Subacromial Impingement Syndrome

Primary Purpose

Subacromial Impingement Syndrome

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
high intensity laser in addition to traditional physical therapy exercises
low level laser in addition to traditional physical therapy exercises
traditional physical therapy exercises
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subacromial Impingement Syndrome

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Physical Therapy, Cairo University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

High laser group

low laser group

control group

Arm Description

Outcomes

Primary Outcome Measures

pain intensity
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

Secondary Outcome Measures

shoulder range of motion
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
pain pressure threshold
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'.
Shoulder Pain and Disability Index
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
Pittsburgh Sleep Quality Index (PSQI)
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.

Full Information

First Posted
March 2, 2021
Last Updated
January 21, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04784377
Brief Title
High and Low Laser for Subacromial Impingement Syndrome
Official Title
High Intensity Versus Low Level Laser Therapy in Treatment of Patients With Subacromial Impingement Syndrome: A Randomized, Double-blind, Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
August 15, 2022 (Actual)
Study Completion Date
September 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Impingement Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High laser group
Arm Type
Experimental
Arm Title
low laser group
Arm Type
Experimental
Arm Title
control group
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
high intensity laser in addition to traditional physical therapy exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
low level laser in addition to traditional physical therapy exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
traditional physical therapy exercises
Intervention Description
Also the patients will receive traditional physical therapy exercises in the form of flexibility and strengthening exercises for shoulder muscles.
Primary Outcome Measure Information:
Title
pain intensity
Description
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
Time Frame
change from base line at three weeks
Secondary Outcome Measure Information:
Title
shoulder range of motion
Description
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
Time Frame
change from baseline at three weeks
Title
pain pressure threshold
Description
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'.
Time Frame
change from baseline at three weeks
Title
Shoulder Pain and Disability Index
Description
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
Time Frame
change from baseline at three weeks
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
change from baseline at three weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Faculty of Physical Therapy, Cairo University
City
Giza
ZIP/Postal Code
12613
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
19250050
Citation
Bal A, Eksioglu E, Gurcay E, Gulec B, Karaahmet O, Cakci A. Low-level laser therapy in subacromial impingement syndrome. Photomed Laser Surg. 2009 Feb;27(1):31-6. doi: 10.1089/pho.2007.2222.
Results Reference
background
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
background
PubMed Identifier
30672303
Citation
Aceituno-Gomez J, Avendano-Coy J, Gomez-Soriano J, Garcia-Madero VM, Avila-Martin G, Serrano-Munoz D, Gonzalez-Gonzalez J, Criado-Alvarez JJ. Efficacy of high-intensity laser therapy in subacromial impingement syndrome: a three-month follow-up controlled clinical trial. Clin Rehabil. 2019 May;33(5):894-903. doi: 10.1177/0269215518824691. Epub 2019 Jan 23.
Results Reference
background

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High and Low Laser for Subacromial Impingement Syndrome

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