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

NCT01449448 | Withdrawn DMC

• 1 other identifier: impingement
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Subacromial Impingement Syndrome; Subacromial Bursitis

Keywords

pain relief; Hypermobility, Joint; increased strength; increased patient satisfaction

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Visual Analog Scale

  4 Weeks

• Range of Motion

  4 Weeks

Study Arms (2)

NSAID

EXPERIMENTAL

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

Drug: Ketorolac

Steroid

ACTIVE COMPARATOR

This group was given a subacromial injection triamcinolone.

Drug: Triamcinolone

Interventions

Ketorolac DRUG

Subacromial injection

NSAID

Triamcinolone DRUG

Subacromial Injection

Steroid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Shoulder pain characteristic of subacromial impingement syndrome with passive and/or active abduction in the 60-120 arc of motion (positive impingement sign)
• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Madigan Army Medical Center: lead

Related Publications (1)

• 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.

  PMID: 23177167 DERIVED

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Joint Instability

Interventions

Ketorolac; Triamcinolone

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Kyong S Min, MD

  Madigan Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2011
• First Posted: October 10, 2011
• Study Start: September 1, 2000
• Primary Completion: September 1, 2005
• Study Completion: September 1, 2005
• Last Updated: November 4, 2016

Record last verified: 2016-11