Skip to main content
Clinical Trials/NCT04779190
NCT04779190
Completed
Not Applicable

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

Istanbul University1 site in 1 country60 target enrollmentMarch 4, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Subacromial Impingement Syndrome
Sponsor
Istanbul University
Enrollment
60
Locations
1
Primary Endpoint
Change from baseline activity pain score at 1-months and 3-months
Status
Completed
Last Updated
4 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
March 4, 2021
End Date
July 10, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ekin Ilke Sen

Assistant Professor

Istanbul University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change from baseline activity pain score at 1-months and 3-months

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

Visual Analogue Scale-Activity pain (0-10 point). Higher scores mean a worse outcome

Secondary Outcomes

  • Change from baseline Shoulder Pain and Disability Index at 1-months and 3-months(Baseline, 1-month, 3-month)
  • Change from baseline rest pain score at 1-months and 3-months(Baseline, 1-month, 3-month)
  • Change from baseline night pain score at 1-months and 3-months(Baseline, 1-month, 3-month)

Study Sites (1)

Loading locations...

Similar Trials