NCT04784377

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

March 15, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
Last Updated

January 25, 2023

Status Verified

March 1, 2021

Enrollment Period

1.4 years

First QC Date

March 2, 2021

Last Update Submit

January 21, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    change from base line at three weeks

Secondary Outcomes (4)

  • shoulder range of motion

    change from baseline at three weeks

  • pain pressure threshold

    change from baseline at three weeks

  • Shoulder Pain and Disability Index

    change from baseline at three weeks

  • Pittsburgh Sleep Quality Index (PSQI)

    change from baseline at three weeks

Study Arms (3)

High laser group

EXPERIMENTAL
Other: high intensity laser in addition to traditional physical therapy exercises

low laser group

EXPERIMENTAL
Other: low level laser in addition to traditional physical therapy exercises

control group

OTHER
Other: traditional physical therapy exercises

Interventions

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.

High laser group

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.

low laser group

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

control group

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Giza, 12613, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 19250050BACKGROUND
  • 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: 33307783BACKGROUND
  • 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.

    PMID: 30672303BACKGROUND

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistance professor doctor

Study Record Dates

First Submitted

March 2, 2021

First Posted

March 5, 2021

Study Start

March 15, 2021

Primary Completion

August 15, 2022

Study Completion

September 15, 2022

Last Updated

January 25, 2023

Record last verified: 2021-03

Locations