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

NCT ID: NCT03120923

Last Updated: 2017-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2016-08-01

Brief Summary

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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

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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.

Conditions

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Impingement Shoulder

Keywords

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subacromial injection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Lidocaine 3 cc & Triamcinolone Acetonide

Group Type EXPERIMENTAL

Lidocaine 3 cc

Intervention Type DRUG

Triamcinolone Acetonide

Intervention Type DRUG

Lidocaine 9cc & Triamcinolone Acetonide

Group Type ACTIVE_COMPARATOR

Lidocaine 9 cc

Intervention Type DRUG

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

Triamcinolone Acetonide

Intervention Type DRUG

Interventions

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Lidocaine 3 cc

Intervention Type DRUG

Lidocaine 9 cc

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

Intervention Type DRUG

Triamcinolone Acetonide

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Khon Kaen University

OTHER

Sponsor Role collaborator

Ramathibodi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jatupon Kongtharvonskul

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Boonard M, Sumanont S, Arirachakaran A, Apiwatanakul P, Boonrod A, Kanchanatawan W, Kongtharvonskul J. Short-term outcomes of subacromial injection of combined corticosteroid with low-volume compared to high-volume local anesthetic for rotator cuff impingement syndrome: a randomized controlled non-inferiority trial. Eur J Orthop Surg Traumatol. 2018 Aug;28(6):1079-1087. doi: 10.1007/s00590-018-2149-3. Epub 2018 Feb 8.

Reference Type DERIVED
PMID: 29423865 (View on PubMed)

Other Identifiers

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HE551338

Identifier Type: -

Identifier Source: org_study_id