Physical Therapy in Shoulder Impingement Syndrome

Istanbul University60 enrolled

Overview

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).

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Subacromial Impingement Syndrome

Interventions

Low-level laser therapyDEVICE

Gallium-aluminum-arsenide diode laser device

Therapeutic ultrasoundDEVICE

Therapeutic pulsed ultrasound with a frequency of 1 MHz

Home-based exerciseOTHER

Home-based exercises 3 days a week; each exercise comprises one set with 5 repetitions over 4 weeks.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Istanbul, Turkey (Türkiye)

Outcomes

Primary Outcomes

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

Time frame: Baseline, 1-month, 3-month

Secondary Outcomes

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

Time frame: 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)

Time frame: 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

Time frame: Baseline, 1-month, 3-month

Data from ClinicalTrials.gov

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