- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01449448
Subacromial Injection With Corticosteroid Versus Nonsteroidal Anti-inflammatory Drugs (NSAID) in Shoulder Impingement Syndrome (NSAID)
November 2, 2016 updated by: Madigan Army Medical Center
A Double-blind Randomized Controlled Trial Comparing the Effects of Subacromial Injection With Corticosteroid Versus NSAID in Patients With Shoulder Impingement Syndrome
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.
Study Overview
Status
Withdrawn
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NSAID
Test Group: This group was given subacromial injections of Ketorolac.
|
Subacromial injection
|
Active Comparator: Steroid
This group was given a subacromial injection triamcinolone.
|
Subacromial Injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
UCLA Shoulder Rating Scale
Time Frame: 4 Weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale
Time Frame: 4 Weeks
|
This is a pain scale.
|
4 Weeks
|
Range of Motion
Time Frame: 4 Weeks
|
Shoulder Range of Motion was assessed with a hand held goniometer
|
4 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kyong S Min, MD, Madigan Army Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2000
Primary Completion (Actual)
September 1, 2005
Study Completion (Actual)
September 1, 2005
Study Registration Dates
First Submitted
October 6, 2011
First Submitted That Met QC Criteria
October 7, 2011
First Posted (Estimate)
October 10, 2011
Study Record Updates
Last Update Posted (Estimate)
November 4, 2016
Last Update Submitted That Met QC Criteria
November 2, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Wounds and Injuries
- Disease
- Joint Diseases
- Musculoskeletal Diseases
- Rupture
- Shoulder Injuries
- Tendon Injuries
- Syndrome
- Rotator Cuff Injuries
- Shoulder Impingement Syndrome
- Bursitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Ketorolac
- Triamcinolone
Other Study ID Numbers
- impingement
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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