Combined Corticosteroid With Low Volume Compared to High Volume in Impingement Syndrome

October 17, 2017 updated by: Jatupon Kongtharvonskul, Ramathibodi Hospital

A Short Term Outcomes of Subacromial Injection of Combined Corticosteroid With Low Volume Compared to High Volume of Local Anesthetic for Rotator Cuff Impingement Syndrome: A Randomized Controlled Trials

This study aims to assess and compare the effectiveness of two different volumes of local anesthetic combined with 40mg of triamcinolone for subacromial injections in treating patients with rotator cuff impingement syndrome

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with rotator cuff impingement syndrome were randomized to undergo subacromial injection with 10mL total volume of 1% lidocaine plus 40mg triamcinolone acetonide (n = 22), or a 4mL total volume of 1% lidocaine plus 40-mg triamcinolone acetonide (n = 23). Evaluations using a visual analog scale (VAS) for pain during motion, and the Western Ontario Rotator Cuff Index (WORC) were completed before treatment and 30 minutes, 2 weeks, and 8 weeks after injection.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 4

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. participants with clinically diagnosed the rotator cuff impingement
  2. participants aged 20 years and older
  3. at least 1 month's duration
  4. pain of moderate to severe intensity, defined as a score of 5 or more points on a 10-cm visual analog scale (VAS) rated from 0 (no pain) to 10 (worst imaginable pain)

Exclusion Criteria:

  1. patients with adhesive capsulitis of the shoulder (normal radiograph of affected shoulder, and restriction of passive motion >30° in ≥2 planes of movement)
  2. previous trauma history at currently affected shoulder
  3. previous corticosteroid injection history at the affected shoulder
  4. abnormal calcification and/or primary osteoarthritis of the shoulder joint on plain radiographs
  5. use of medication such as antiplatelet agent or anticoagulation.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lidocaine 3 cc & Triamcinolone Acetonide
Drug: Triamcinolone Acetonide
Drug: Lidocaine 3 cc
Active Comparator: Lidocaine 9cc & Triamcinolone Acetonide
Drug: Triamcinolone Acetonide
Drug: Lidocaine 9 cc
9mL of 1% lidocaine plus 1mL of 40mg triamcinolone acetonide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS
Time Frame: 8 weeks
Visual analog score
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WORC
Time Frame: 8 weeks
Western Ontario Rotator Cuff Index
8 weeks
Adverse reaction
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

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

Sponsor

Ramathibodi Hospital

Collaborators

Khon Kaen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

April 16, 2017

First Submitted That Met QC Criteria

April 16, 2017

First Posted (Actual)

April 19, 2017

Study Record Updates

Last Update Posted (Actual)

October 18, 2017

Last Update Submitted That Met QC Criteria

October 17, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE551338

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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