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

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

Sponsors

Lead sponsor: Madigan Army Medical Center

Source 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.

Overall Status Withdrawn
Start Date September 2000
Completion Date September 2005
Primary Completion Date September 2005
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
UCLA Shoulder Rating Scale 4 Weeks
Secondary Outcome
Measure Time Frame
Visual Analog Scale 4 Weeks
Range of Motion 4 Weeks
Condition
Intervention

Intervention type: Drug

Intervention name: Ketorolac

Description: Subacromial injection

Arm group label: NSAID

Intervention type: Drug

Intervention name: Triamcinolone

Description: Subacromial Injection

Arm group label: Steroid

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Kyong S Min, MD Principal Investigator Madigan Army Medical Center
Verification Date

November 2016

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: NSAID

Arm group type: Experimental

Description: Test Group: This group was given subacromial injections of Ketorolac.

Arm group label: Steroid

Arm group type: Active Comparator

Description: This group was given a subacromial injection triamcinolone.

Acronym NSAID
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov