High and Low Laser for Subacromial Impingement Syndrome
High Intensity Versus Low Level Laser Therapy in Treatment of Patients With Subacromial Impingement Syndrome: A Randomized, Double-blind, Controlled Trial.
1 other identifier
interventional
42
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2021
CompletedFirst Posted
Study publicly available on registry
March 5, 2021
CompletedStudy Start
First participant enrolled
March 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2022
CompletedJanuary 25, 2023
March 1, 2021
1.4 years
March 2, 2021
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
EXPERIMENTALlow laser group
EXPERIMENTALcontrol group
OTHERInterventions
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.
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.
Also the patients will receive traditional physical therapy exercises in the form of flexibility and strengthening exercises for shoulder muscles.
Eligibility Criteria
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
- Cairo Universitylead
Study Sites (1)
Faculty of Physical Therapy, Cairo University
Giza, 12613, Egypt
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: 19250050BACKGROUNDAlfredo 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: 33307783BACKGROUNDAceituno-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
Condition Hierarchy (Ancestors)
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