Clinical trial NCT01449448: Subacromial Injection With Corticosteroid Versus Nonsteroidal Anti-inflammatory Drugs (NSAID) in Shoulder Impingement Syndrome
Official title: A Double-blind Randomized Controlled Trial Comparing the Effects of Subacromial Injection With Corticosteroid Versus NSAID in Patients With Shoulder Impingement Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Subacromial Impingement Syndrome
Subacromial Bursitis
Keywords: pain relief
Hypermobility, Joint
increased strength
increased patient satisfaction
Lead sponsor: Madigan Army Medical Center
Sponsor class: FED
First posted: 2011-10-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: UCLA Shoulder Rating Scale
timeFrame: 4 Weeks
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: 4 Weeks
measure: Range of Motion
timeFrame: 4 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Madigan Army Medical Center
name: Kyong S Min, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.