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

• Sponsor: Ramathibodi Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03120923
• Collaborator: Khon Kaen University (Other)
• Enrollment: 52
• Arms: 2
• Actual Duration (Months): 19

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Impingement Shoulder	Drug: Lidocaine 3 cc; Drug: Lidocaine 9 cc; Drug: Triamcinolone Acetonide	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. VAS [8 weeks]

   Visual analog score

Secondary Outcome Measures

1. WORC [8 weeks]

   Western Ontario Rotator Cuff Index

2. Adverse reaction [8 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ramathibodi Hospital
• Khon Kaen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jatupon Kongtharvonskul, Dr, Khon Kaen University
• ClinicalTrials.gov Identifier: NCT03120923
• Other Study ID Numbers: HE551338
• First Posted: Apr 19, 2017
• Last Update Posted: Oct 18, 2017
• Last Verified: Oct 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jatupon Kongtharvonskul, Dr, Khon Kaen University: subacromial injection
• Additional relevant MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Lidocaine; Triamcinolone diacetate

Study Results

No Results Posted as of Oct 18, 2017