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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01449448
Acronym
NSAID
Enrollment
0
Registered
2011-10-10
Start date
2000-09-30
Completion date
2005-09-30
Last updated
2016-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subacromial Bursitis, Subacromial Impingement Syndrome

Keywords

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

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.

Interventions

DRUGKetorolac

Subacromial injection

DRUGTriamcinolone

Subacromial Injection

Sponsors

Madigan Army Medical Center
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
UCLA Shoulder Rating Scale4 WeeksThis 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.

Secondary

MeasureTime frameDescription
Visual Analog Scale4 WeeksThis is a pain scale.
Range of Motion4 WeeksShoulder Range of Motion was assessed with a hand held goniometer

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026