Subacromial Impingement Syndrome
Conditions
Brief summary
The aim of this study is to evaluate the effects of low-level laser therapy (LLLT) and therapeutic ultrasound combined with home-based exercise in comparison with home-based exercise alone in patients with subacromial impingement syndrome (SIS). Participants are going to evaluate before training, and at the 1-month follow-up and 3-month follow-up using the visual analog scale (VAS) scores for pain during activity, at rest, and at night, and the Shoulder Pain and Disability Index (SPADI).
Detailed description
SIS is an important cause of pain and disability and affects activities of daily living. Therefore, a major goal of SIS treatment is to reduce pain and improve upper extremity function. In this prospective, randomized controlled, single-blind, interventional trial, a total of 60 patients with SIS who met the eligibility criteria are going to enrolled in the study. Eligible participants are going to randomly assign to one of the three groups by an independent blinded researcher, using a computer-generated random numbers and allocation ratio of 1:1:1: the LLLT group (LG, n = 20), the ultrasound therapy group (UG, n = 20), and the control group (CG, n = 20). Participants are going to evaluate before training, and at the 1-month follow-up and 3-month follow-up using the visual analog scale (VAS) scores for pain during activity, at rest, and at night, and the Shoulder Pain and Disability Index (SPADI).
Interventions
DEVICELow-level laser therapy
Gallium-aluminum-arsenide diode laser device
DEVICETherapeutic ultrasound
Therapeutic pulsed ultrasound with a frequency of 1 MHz
OTHERHome-based exercise
Home-based exercises 3 days a week; each exercise comprises one set with 5 repetitions over 4 weeks.
Sponsors
Istanbul University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of subacromial impingement syndrome based on physical examinations * Persistent pain in one shoulder for at least 2 months * No passive shoulder range of motion limitations * Failure of improvement in pain after analgesic medications
Exclusion criteria
* History of malignancy and systemic rheumatic diseases * Evidence of systemic or local infection * Presence of major trauma at the affected shoulder * History of shoulder surgery * Rotator cuff lesions in the form of either calcific tendinosis or full-thickness tear as confirmed on MRI scanning
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline activity pain score at 1-months and 3-months | Baseline, 1-month, 3-month | Visual Analogue Scale-Activity pain (0-10 point). Higher scores mean a worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline rest pain score at 1-months and 3-months | Baseline, 1-month, 3-month | Visual Analogue Scale-Rest pain (0-10 point). Higher scores mean a worse outcome |
| Change from baseline Shoulder Pain and Disability Index at 1-months and 3-months | Baseline, 1-month, 3-month | Shoulder Pain and Disability Index (SPADI) measures shoulder pain and shoulder disability. Total score ranges from 0 to 130, where a higher score indicates a worsening status. Each item is scored with the VAS, which ranges from 0 (no pain or no difficulty) to 10 (worst pain imaginable or very difficult, help required) |
| Change from baseline night pain score at 1-months and 3-months | Baseline, 1-month, 3-month | Visual Analogue Scale- Night pain (0-10 point). Higher scores mean a worse outcome |
Countries
Turkey (Türkiye)
Outcome results
None listed