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Physical Therapy in Shoulder Impingement Syndrome

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ClinicalTrials.gov Identifier: NCT04779190
Recruitment Status : Completed
First Posted : March 3, 2021
Last Update Posted : July 16, 2021
Sponsor:
Information provided by (Responsible Party):
Ekin Ilke Sen, Istanbul University

Study Description
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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).

Condition or disease Intervention/treatment Phase
Subacromial Impingement Syndrome Device: Low-level laser therapy Device: Therapeutic ultrasound Other: Home-based exercise Not Applicable

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Low-level Laser Therapy Versus Ultrasound Therapy Combined With Exercise in Patients With Subacromial Impingement Syndrome
Actual Study Start Date : March 4, 2021
Actual Primary Completion Date : July 10, 2021
Actual Study Completion Date : July 10, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Device: Low-level laser therapy
Gallium-aluminum-arsenide diode laser device

Other: Home-based exercise
Home-based exercises 3 days a week; each exercise comprises one set with 5 repetitions over 4 weeks.
Experimental: 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.
 Device: Therapeutic ultrasound
Therapeutic pulsed ultrasound with a frequency of 1 MHz

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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04779190


Locations
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Turkey
Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Istanbul, Turkey
Sponsors and Collaborators
Istanbul University
Investigators
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Study Director: Nalan Capan Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
More Information
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Responsible Party: Ekin Ilke Sen, Assistant Professor, Istanbul University
ClinicalTrials.gov Identifier: NCT04779190    
Other Study ID Numbers: IstanbulU-2017-855
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: July 16, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Shoulder Impingement Syndrome
Syndrome
Rotator Cuff Injuries
Disease
Pathologic Processes
Rupture
 Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Joint Diseases
Musculoskeletal Diseases