Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Madigan Army Medical Center
ClinicalTrials.gov Identifier:
NCT01449448
First received: October 6, 2011
Last updated: October 7, 2011
Last verified: October 2011
History of Changes
  Purpose

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 Intervention
Subacromial Impingement Syndrome
Subacromial Bursitis
 Drug: Ketorolac
Drug: Triamcinolone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Madigan Army Medical Center:

Primary Outcome Measures:
  • UCLA Shoulder Rating Scale [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
    This is a pain scale.

  • Range of Motion [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
    Shoulder Range of Motion was assessed with a hand held goniometer


Enrollment: 32
Study Start Date: September 2000
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01449448

Locations
United States, Washington
Madigan Healthcare System
Tacoma, Washington, United States, 98327
Sponsors and Collaborators
Madigan Army Medical Center
  More Information

No publications provided

Responsible Party: Madigan Army Medical Center
ClinicalTrials.gov Identifier: NCT01449448     History of Changes
Other Study ID Numbers: Impingement
Study First Received: October 6, 2011
Last Updated: October 7, 2011
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Bursitis
Shoulder Impingement Syndrome
Joint Diseases
Musculoskeletal Diseases
Triamcinolone hexacetonide
Anti-Inflammatory Agents
Triamcinolone
Triamcinolone Acetonide
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Triamcinolone diacetate
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013