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

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ClinicalTrials.gov Identifier: NCT01449448
Recruitment Status : Withdrawn (PI didn't have time to finish approval process)
First Posted : October 10, 2011
Last Update Posted : November 4, 2016
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Subacromial Impingement Syndrome Subacromial Bursitis Drug: Ketorolac Drug: Triamcinolone

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2000
Primary Completion Date : September 2005
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: NSAID
Test Group: This group was given subacromial injections of Ketorolac.
Drug: Ketorolac
Subacromial injection
Active Comparator: Steroid
This group was given a subacromial injection triamcinolone.
Drug: Triamcinolone
Subacromial Injection


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Visual Analog Scale [ Time Frame: 4 Weeks ]
    This is a pain scale.

  2. Range of Motion [ Time Frame: 4 Weeks ]
    Shoulder Range of Motion was assessed with a hand held goniometer


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01449448


Sponsors and Collaborators
Madigan Army Medical Center
Investigators
Principal Investigator: Kyong S Min, MD Madigan Army Medical Center
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Madigan Army Medical Center
ClinicalTrials.gov Identifier: NCT01449448     History of Changes
Other Study ID Numbers: impingement
First Posted: October 10, 2011    Key Record Dates
Last Update Posted: November 4, 2016
Last Verified: November 2016

Keywords provided by Madigan Army Medical Center:
pain relief
Hypermobility, Joint
increased strength
increased patient satisfaction

Additional relevant MeSH terms:
Syndrome
Rotator Cuff Injuries
Shoulder Impingement Syndrome
Bursitis
Disease
Pathologic Processes
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Joint Diseases
Musculoskeletal Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Ketorolac
Ketorolac Tromethamine
Triamcinolone diacetate
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Analgesics