Back to resultsSubacromial Injection With Corticosteroid Versus Nonsteroidal Anti-inflammatory Drugs (NSAID) in Shoulder Impingement Syndrome (NSAID)
Primary Purpose
Subacromial Impingement Syndrome, Subacromial Bursitis
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ketorolac
Triamcinolone
Sponsored by
About this trial
This is an interventional treatment trial for Subacromial Impingement Syndrome focused on measuring pain relief, Hypermobility, Joint, increased strength, increased patient satisfaction
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NSAID
Steroid
Arm Description
Test Group: This group was given subacromial injections of Ketorolac.
This group was given a subacromial injection triamcinolone.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Visual Analog Scale
This is a pain scale.
Range of Motion
Shoulder Range of Motion was assessed with a hand held goniometer
Full Information
NCT ID
NCT01449448
First Posted
October 6, 2011
Last Updated
November 2, 2016
Sponsor
Madigan Army Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01449448
Brief Title
Subacromial Injection With Corticosteroid Versus Nonsteroidal Anti-inflammatory Drugs (NSAID) in Shoulder Impingement Syndrome
Acronym
NSAID
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
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Withdrawn
Why Stopped
PI didn't have time to finish approval process
Study Start Date
September 2000 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Madigan Army Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Impingement Syndrome, Subacromial Bursitis
Keywords
pain relief, Hypermobility, Joint, increased strength, increased patient satisfaction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NSAID
Arm Type
Experimental
Arm Description
Test Group: This group was given subacromial injections of Ketorolac.
Arm Title
Steroid
Arm Type
Active Comparator
Arm Description
This group was given a subacromial injection triamcinolone.
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Intervention Description
Subacromial injection
Intervention Type
Drug
Intervention Name(s)
Triamcinolone
Intervention Description
Subacromial Injection
Primary Outcome Measure Information:
Title
UCLA Shoulder Rating Scale
Description
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.
Time Frame
4 Weeks
Secondary Outcome Measure Information:
Title
Visual Analog Scale
Description
This is a pain scale.
Time Frame
4 Weeks
Title
Range of Motion
Description
Shoulder Range of Motion was assessed with a hand held goniometer
Time Frame
4 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyong S Min, MD
Organizational Affiliation
Madigan Army Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
23177167
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.
Results Reference
derived
Learn more about this trial
Subacromial Injection With Corticosteroid Versus Nonsteroidal Anti-inflammatory Drugs (NSAID) in Shoulder Impingement Syndrome
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