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

NCT ID: NCT01449448

Last Updated: 2016-11-04

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Study Completion Date

2005-09-30

Brief Summary

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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

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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.

Conditions

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Subacromial Impingement Syndrome Subacromial Bursitis

Keywords

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pain relief Hypermobility, Joint increased strength increased patient satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NSAID

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

Group Type EXPERIMENTAL

Ketorolac

Intervention Type DRUG

Subacromial injection

Steroid

This group was given a subacromial injection triamcinolone.

Group Type ACTIVE_COMPARATOR

Triamcinolone

Intervention Type DRUG

Subacromial Injection

Interventions

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Ketorolac

Subacromial injection

Intervention Type DRUG

Triamcinolone

Subacromial Injection

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Madigan Army Medical Center

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyong S Min, MD

Role: PRINCIPAL_INVESTIGATOR

Madigan Army Medical Center

Countries

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United States

References

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Min KS, St Pierre P, Ryan PM, Marchant BG, Wilson CJ, Arrington ED. A double-blind randomized controlled trial comparing the effects of subacromial injection with corticosteroid versus NSAID in patients with shoulder impingement syndrome. J Shoulder Elbow Surg. 2013 May;22(5):595-601. doi: 10.1016/j.jse.2012.08.026. Epub 2012 Nov 22.

Reference Type DERIVED
PMID: 23177167 (View on PubMed)

Other Identifiers

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impingement

Identifier Type: -

Identifier Source: org_study_id