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Completed

NCT Number: NCT04779190

Physical Therapy in Shoulder Impingement Syndrome

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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Key information

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Istanbul, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-Level Laser Therapy

Device

Gallium-aluminum-arsenide diode laser device

Therapeutic Ultrasound

Device

Therapeutic pulsed ultrasound with a frequency of 1 MHz

Home-based exercise

Other

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

Primary outcomes

  1. 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

  1. Change from baseline rest pain score at 1-months and 3-months

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

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

  2. Change from baseline Shoulder Pain and Disability Index at 1-months and 3-months

    Time frame: 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)

  3. Change from baseline night pain score at 1-months and 3-months

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

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

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 3, 2021
Registry last updated
Jul 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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