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Completed

NCT Number: NCT03120923

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

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

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • participants with clinically diagnosed the rotator cuff impingement
  • participants aged 20 years and older
  • at least 1 month's duration
  • 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

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

Treatment and study plan

Lidocaine 3 cc

Drug

Lidocaine 9 cc

Drug

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

Triamcinolone Acetonide

Drug

Primary outcomes

  1. VAS

    Time frame: 8 weeks

    Visual analog score

Secondary outcomes

  1. WORC

    Time frame: 8 weeks

    Western Ontario Rotator Cuff Index

  2. Adverse reaction

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Ramathibodi Hospital

Other

Collaborators

  • Khon Kaen University

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 19, 2017
Registry last updated
Oct 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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