Physical Therapy in Shoulder Impingement Syndrome

Study Overview
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Brief Summary
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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
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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).

Official Title
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Low-level Laser Therapy Versus Ultrasound Therapy Combined With Exercise in Patients With Subacromial Impingement Syndrome

Conditions
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Subacromial Impingement Syndrome

Intervention / Treatment
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* Device: Low-level laser therapy
* Device: Therapeutic ultrasound
* Other: Home-based exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-level laser therapy<br>In the low-level laser therapy group, each patient are going to receive low-level laser therapy and cold-pack therapy and perform a home-based exercise program 5 times a week, once a day for 15 sessions. | Device: Low-level laser therapy<br>* Gallium-aluminum-arsenide diode laser device<br>Other: Home-based exercise<br>* Home-based exercises 3 days a week; each exercise comprises one set with 5 repetitions over 4 weeks.<br>|
| Experimental: Therapeutic ultrasound<br>In the therapeutic ultrasound group, each patient are going to receive therapeutic ultrasound and cold-pack therapy and perform a home-based exercise program 5 times a week, once a day for 15 sessions. | Device: Therapeutic ultrasound<br>* Therapeutic pulsed ultrasound with a frequency of 1 MHz<br>Other: Home-based exercise<br>* Home-based exercises 3 days a week; each exercise comprises one set with 5 repetitions over 4 weeks.<br>|
| Active Comparator: Control<br>Participants are going to perform a home-based exercise program and receive cold-pack therapy 5 times a week, once a day for 15 sessions. | Other: Home-based exercise<br>* Home-based exercises 3 days a week; each exercise comprises one set with 5 repetitions over 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline activity pain score at 1-months and 3-months | Visual Analogue Scale-Activity pain (0-10 point). Higher scores mean a worse outcome | Baseline, 1-month, 3-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline rest pain score at 1-months and 3-months | Visual Analogue Scale-Rest pain (0-10 point). Higher scores mean a worse outcome | Baseline, 1-month, 3-month | 
| Change from baseline Shoulder Pain and Disability Index at 1-months and 3-months | 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) | Baseline, 1-month, 3-month | 
| Change from baseline night pain score at 1-months and 3-months | Visual Analogue Scale- Night pain (0-10 point). Higher scores mean a worse outcome | Baseline, 1-month, 3-month |