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

Impingement Shoulder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03120923
• Other study ID #: HE551338
• Status: Completed
• Phase: Phase 4
• First received: April 16, 2017
• Last updated: October 17, 2017
• Start date: January 1, 2015
• Est. completion date: August 1, 2016

Study information

• Verified date: October 2017
• Source: Ramathibodi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 1, 2016
• Est. primary completion date: August 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Impingement Shoulder

Intervention

Drug:
• Lidocaine 3 cc

• Lidocaine 9 cc
9mL of 1% lidocaine plus 1mL of 40mg triamcinolone acetonide
• Triamcinolone Acetonide

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ramathibodi Hospital	Khon Kaen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS	Visual analog score	8 weeks
Secondary	WORC	Western Ontario Rotator Cuff Index	8 weeks
Secondary	Adverse reaction		8 weeks