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

Subacromial Impingement Syndrome Clinical Trial

— NSAID  

Official title:

A Double-blind Randomized Controlled Trial Comparing the Effects of Subacromial Injection With Corticosteroid Versus NSAID in Patients With Shoulder Impingement Syndrome

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01449448
• Other study ID #: impingement
• Status: Withdrawn
• Phase: N/A
• First received: October 6, 2011
• Last updated: November 2, 2016
• Start date: September 2000
• Est. completion date: September 2005

Study information

• Verified date: November 2016
• Source: Madigan Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bursitis
• Shoulder Impingement Syndrome
• Subacromial Bursitis
• Subacromial Impingement Syndrome
• Syndrome

Intervention

Drug:
• Ketorolac
Subacromial injection
• Triamcinolone
Subacromial Injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Madigan Army Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	UCLA Shoulder Rating Scale	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.	4 Weeks	No
Secondary	Visual Analog Scale	This is a pain scale.	4 Weeks	No
Secondary	Range of Motion	Shoulder Range of Motion was assessed with a hand held goniometer	4 Weeks	No