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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01449448
Other study ID # impingement
Secondary ID
Status Withdrawn
Phase N/A
First received October 6, 2011
Last updated November 2, 2016
Start date September 2000
Est. completion date September 2005

Study information

Verified date November 2016
Source Madigan Army Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 2005
Est. primary completion date September 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
Ketorolac
Subacromial injection
Triamcinolone
Subacromial Injection

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Madigan Army Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Visual Analog Scale This is a pain scale. 4 Weeks No
Secondary Range of Motion Shoulder Range of Motion was assessed with a hand held goniometer 4 Weeks No
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