Clinical trial NCT04784377: 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
Overall status: COMPLETED
Phase: NA
Conditions: Subacromial Impingement Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 42
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: pain intensity
timeFrame: change from base line at three weeks
Secondary outcomes:
measure: shoulder range of motion
timeFrame: change from baseline at three weeks
measure: pain pressure threshold
timeFrame: change from baseline at three weeks
measure: Shoulder Pain and Disability Index
timeFrame: change from baseline at three weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: change from baseline at three weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy, Cairo University
Study officials:
References:
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.
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.
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.