Hyaluronic Acid, Corticosteroid and Electrotherapy in Subacromial Impingement Syndrome

April 5, 2021 updated by: Şeyhmus KAPLAN

Subakromiyal sıkışma Sendromunda Hyaluronik Asit, Kortikosteroid ve Elektroterapi

Background: Electrotherapy, corticosteroid, and hyaluronic acid have been used to treat subacromial impingement syndrome. However, we need to compare treatment options to provide the optimal results. This study aims to compare the effect of hyaluronic acid, corticosteroid, and electrotherapy in subacromial impingement syndrome.

Design: Ninety five patients were randomised into three equal groups according to treatment types. Hyaluronic acid (20 mg/2ml, three times one week apart) or corticosteroid (triamcinolone acetonide, 40 mg/ml, single dose) treatments were applied as subacromial injections. Electrotherapy consisted of 14 sessions TENS (20 min.), hotpack (20 min.) and ultrasound (1.5watt/cm2, 1 MHz, 6 min.). Patients were evaluated before treatment, one and four weeks post end of treatment. Visual Analogue Scale (VAS), range of motion (ROM), and Shoulder Disability Questionnaire (SDQ) were used as outcome measures.

Study Overview

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The diagnosis of subacromial impingement syndrome

Exclusion Criteria:

  • Patients aged <20 or >50 years or who have the following medical conditions were excluded: physical therapy or injection in the past 6 months, shoulder instability, acute trauma, adhesive capsulitis, psychiatric illness, diabetes mellitus, malignancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Electrotherapy
electrotherapy
Active Comparator: corticosteroid
triamcinolone acetonide, 40 mg/ml, single dose
Active Comparator: hyaluronic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale
Time Frame: 1 min.
Higher scores represent higher level of shoulder pain.
1 min.
range of motion
Time Frame: 5 min.
Higher scores represent lower level of shoulder function.
5 min.
Shoulder Disability Questionnaire
Time Frame: 15 min
Higher scores represent higher level of shoulder pain.
15 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2013

Primary Completion (Actual)

December 10, 2013

Study Completion (Actual)

May 28, 2014

Study Registration Dates

First Submitted

April 2, 2021

First Submitted That Met QC Criteria

April 5, 2021

First Posted (Actual)

April 6, 2021

Study Record Updates

Last Update Posted (Actual)

April 6, 2021

Last Update Submitted That Met QC Criteria

April 5, 2021

Last Verified

April 1, 2021

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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