NCT04833738

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 11, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2014

Completed
6.9 years until next milestone

First Submitted

Initial submission to the registry

April 2, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 6, 2021

Completed
Last Updated

April 6, 2021

Status Verified

April 1, 2021

Enrollment Period

3 months

First QC Date

April 2, 2021

Last Update Submit

April 5, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Visual Analogue Scale

    Higher scores represent higher level of shoulder pain.

    1 min.

  • range of motion

    Higher scores represent lower level of shoulder function.

    5 min.

  • Shoulder Disability Questionnaire

    Higher scores represent higher level of shoulder pain.

    15 min

Study Arms (3)

Electrotherapy

ACTIVE COMPARATOR
Other: Electrotherapy

corticosteroid

ACTIVE COMPARATOR
Drug: Corticosteroids Triamcinolone Acetonide

hyaluronic acid

ACTIVE COMPARATOR
Drug: Hyaluronic acid

Interventions

hyaluronic acid

triamcinolone acetonide, 40 mg/ml, single dose

corticosteroid

electrotherapy

Electrotherapy

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The diagnosis of subacromial impingement syndrome

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Shoulder Impingement SyndromeShoulder Pain

Interventions

Hyaluronic AcidTriamcinoloneElectric Stimulation Therapy

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and InjuriesArthralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydratesPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Department of Sports Medicine

Study Record Dates

First Submitted

April 2, 2021

First Posted

April 6, 2021

Study Start

September 11, 2013

Primary Completion

December 10, 2013

Study Completion

May 28, 2014

Last Updated

April 6, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share