Subacromial Injection With Corticosteroid Versus Nonsteroidal Anti-inflammatory Drugs (NSAID) in Shoulder Impingement Syndrome

Not Applicable

Withdrawn

• Conditions: Subacromial Bursitis; Subacromial Impingement Syndrome
• Interventions: Drug: Ketorolac; Drug: Triamcinolone

• Registration Number: NCT01449448
• Lead Sponsor: Madigan Army Medical Center

Brief Summary

Injection with corticosteroid is one of the most common non-operative interventions in the treatment of subacromial impingement; however, its use is limited by its potential side effects (e.g. tendon rupture, subcutaneous atrophy, articular cartilage changes). The objective of this study was to compare the efficacy of subacromial injection of triamcinolone compared to injection of ketorolac. Thirty-two patients diagnosed with external shoulder impingement syndrome were included in this double-blinded randomized controlled clinical trial. Each patient was randomized into the Steroid group or NSAID group.

Detailed Description

After a single injection into the subacromial space, the patients were instructed to perform home physical therapy and follow-up in four weeks. Each patient was evaluated in terms of arc of motion, Visual Analog Scale and the UCLA Shoulder Rating Scale.

The outcome measures were taken at the preinjection state, immediately post injection, and at 4 weeks follow-up.

Study Timeline

• Study Start: 2000-09
• Primary Completion: 2005-09
• Study Completion: 2005-09
• Study First Submitted: 2011-10-06
• Study First Submitted QC: 2011-10-07
• Study First Posted: 2011-10-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-02
• Last Update Posted: 2016-11-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Shoulder pain characteristic of subacromial impingement syndrome with passive and/or active abduction in the 60-120 arc of motion (positive impingement sign)
2. Diagnosis of subacromial bursitis based on tenderness to palpation anterior/lateral to the acromion. Pain may be exacerbated with the shoulder held in internal rotation (positive Hawkins test)

Exclusion Criteria

1. Age <18 years
2. Symptoms less than one month
3. Previous shoulder injections within the past 3 months
4. Evidence of os-acromiale or other confounding shoulder pathology on plain radiographs
5. Evidence of shoulder osteoarthritis
6. Full thickness rotator cuff tear evidenced by MRI, cuff weakness after lidocaine injection, or positive drop-arm sign
7. Systemic inflammatory condition
8. Pending litigation or work-related claims related to the shoulder
9. Previous shoulder surgery on the affected shoulder
10. Evidence of local infection
11. Evidence of adhesive capsulitis
12. Previous history of gastrointestinal ulcers or bleeding disorders
13. Evidence of shoulder instability

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NSAID	Ketorolac	Test Group: This group was given subacromial injections of Ketorolac.
Steroid	Triamcinolone	This group was given a subacromial injection triamcinolone.

Primary Outcome Measures

Name	Time	Method
UCLA Shoulder Rating Scale	4 Weeks	This scoring system consists of subjective assessments of pain, function and satisfaction, as well as objective measurements of active forward elevation and strength in forward flexion.

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale	4 Weeks	This is a pain scale.
Range of Motion	4 Weeks	Shoulder Range of Motion was assessed with a hand held goniometer