Hyaluronic Acid, Corticosteroid and Electrotherapy in Subacromial Impingement Syndrome
Primary Purpose
Subacromial Impingement, Pain, Shoulder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hyaluronic acid
Corticosteroids Triamcinolone Acetonide
Electrotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Subacromial Impingement
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Electrotherapy
corticosteroid
hyaluronic acid
Arm Description
Outcomes
Primary Outcome Measures
Visual Analogue Scale
Higher scores represent higher level of shoulder pain.
range of motion
Higher scores represent lower level of shoulder function.
Shoulder Disability Questionnaire
Higher scores represent higher level of shoulder pain.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04833738
Brief Title
Hyaluronic Acid, Corticosteroid and Electrotherapy in Subacromial Impingement Syndrome
Official Title
Subakromiyal sıkışma Sendromunda Hyaluronik Asit, Kortikosteroid ve Elektroterapi
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 11, 2013 (Actual)
Primary Completion Date
December 10, 2013 (Actual)
Study Completion Date
May 28, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Şeyhmus KAPLAN
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Impingement, Pain, Shoulder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electrotherapy
Arm Type
Active Comparator
Arm Title
corticosteroid
Arm Type
Active Comparator
Arm Title
hyaluronic acid
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Hyaluronic acid
Intervention Type
Drug
Intervention Name(s)
Corticosteroids Triamcinolone Acetonide
Intervention Description
triamcinolone acetonide, 40 mg/ml, single dose
Intervention Type
Other
Intervention Name(s)
Electrotherapy
Intervention Description
electrotherapy
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
Higher scores represent higher level of shoulder pain.
Time Frame
1 min.
Title
range of motion
Description
Higher scores represent lower level of shoulder function.
Time Frame
5 min.
Title
Shoulder Disability Questionnaire
Description
Higher scores represent higher level of shoulder pain.
Time Frame
15 min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hyaluronic Acid, Corticosteroid and Electrotherapy in Subacromial Impingement Syndrome
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