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Physical Therapy in Shoulder Impingement Syndrome

Primary Purpose

Subacromial Impingement Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Low-level laser therapy
Therapeutic ultrasound
Home-based exercise
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subacromial Impingement Syndrome

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Low-level laser therapy

Therapeutic ultrasound

Control

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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)
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

Full Information

First Posted
February 26, 2021
Last Updated
July 14, 2021
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT04779190
Brief Title
Physical Therapy in Shoulder Impingement Syndrome
Official Title
Low-level Laser Therapy Versus Ultrasound Therapy Combined With Exercise in Patients With Subacromial Impingement Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 4, 2021 (Actual)
Primary Completion Date
July 10, 2021 (Actual)
Study Completion Date
July 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Impingement Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-level laser therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Therapeutic ultrasound
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Low-level laser therapy
Intervention Description
Gallium-aluminum-arsenide diode laser device
Intervention Type
Device
Intervention Name(s)
Therapeutic ultrasound
Intervention Description
Therapeutic pulsed ultrasound with a frequency of 1 MHz
Intervention Type
Other
Intervention Name(s)
Home-based exercise
Intervention Description
Home-based exercises 3 days a week; each exercise comprises one set with 5 repetitions over 4 weeks.
Primary Outcome Measure Information:
Title
Change from baseline activity pain score at 1-months and 3-months
Description
Visual Analogue Scale-Activity pain (0-10 point). Higher scores mean a worse outcome
Time Frame
Baseline, 1-month, 3-month
Secondary Outcome Measure Information:
Title
Change from baseline rest pain score at 1-months and 3-months
Description
Visual Analogue Scale-Rest pain (0-10 point). Higher scores mean a worse outcome
Time Frame
Baseline, 1-month, 3-month
Title
Change from baseline Shoulder Pain and Disability Index at 1-months and 3-months
Description
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
Title
Change from baseline night pain score at 1-months and 3-months
Description
Visual Analogue Scale- Night pain (0-10 point). Higher scores mean a worse outcome
Time Frame
Baseline, 1-month, 3-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nalan Capan
Organizational Affiliation
Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

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Physical Therapy in Shoulder Impingement Syndrome

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