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

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

Sponsors

Lead sponsor: Ramathibodi Hospital

Collaborator: Khon Kaen University

Source Ramathibodi Hospital
Brief Summary

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

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.

Overall Status Completed
Start Date January 1, 2015
Completion Date August 1, 2016
Primary Completion Date August 1, 2016
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
VAS 8 weeks
Secondary Outcome
Measure Time Frame
WORC 8 weeks
Adverse reaction 8 weeks
Enrollment 52
Condition
Intervention

Intervention type: Drug

Intervention name: Lidocaine 3 cc

Arm group label: Lidocaine 3 cc & Triamcinolone Acetonide

Intervention type: Drug

Intervention name: Lidocaine 9 cc

Description: 9mL of 1% lidocaine plus 1mL of 40mg triamcinolone acetonide

Arm group label: Lidocaine 9cc & Triamcinolone Acetonide

Intervention type: Drug

Intervention name: Triamcinolone Acetonide

Eligibility

Criteria:

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.

Gender: All

Minimum age: 20 Years

Maximum age: N/A

Healthy volunteers: No

Verification Date

October 2017

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Khon Kaen University

Investigator full name: Jatupon Kongtharvonskul

Investigator title: Dr

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Arm group label: Lidocaine 3 cc & Triamcinolone Acetonide

Arm group type: Experimental

Arm group label: Lidocaine 9cc & Triamcinolone Acetonide

Arm group type: Active Comparator

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov