Physical Therapy in Shoulder Impingement Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-04

Study Completion Date

2021-07-10

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).

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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).

Conditions

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Subacromial Impingement Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Low-level laser therapy

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.

Group Type EXPERIMENTAL

Low-level laser therapy

Intervention Type DEVICE

Gallium-aluminum-arsenide diode laser device

Home-based exercise

Intervention Type OTHER

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

Therapeutic ultrasound

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.

Group Type EXPERIMENTAL

Therapeutic ultrasound

Intervention Type DEVICE

Therapeutic pulsed ultrasound with a frequency of 1 MHz

Home-based exercise

Intervention Type OTHER

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

Control

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.

Group Type ACTIVE_COMPARATOR

Home-based exercise

Intervention Type OTHER

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

Interventions

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Low-level laser therapy

Gallium-aluminum-arsenide diode laser device

Intervention Type DEVICE

Therapeutic ultrasound

Therapeutic pulsed ultrasound with a frequency of 1 MHz

Intervention Type DEVICE

Home-based exercise

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

Intervention Type OTHER

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No