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Trial record 11 of 463 for:    KETOROLAC

Subacromial Methylprednisolone Versus Ketorolac for Shoulder Impingement

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ClinicalTrials.gov Identifier: NCT03913702
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

Brief Summary:
The investigators aim to compare subacromial ketorolac (non-steroidal anti-inflammatory drug) versus methylprednisolone (steroid) for the treatment of shoulder impingement syndrome.

Condition or disease Intervention/treatment Phase
Subacromial Impingement Subacromial Impingement Syndrome Drug: Ketorolac Tromethamine Drug: Methylprednisolone Acetate Phase 2

Detailed Description:
Because of the current conflicting evidence, the lack of long-term follow-up, and the multiple potential benefit benefits to the society, the investigators aim to compare subacromial ketorolac versus methylprednisolone for the treatment of shoulder impingement syndrome. The investigators hypothesize that patients with shoulder impingement treated with a subacromial methylprednisolone versus ketorolac have similar outcomes based on the ASES (American Shoulder and Elbow Surgeon) self-assessment score. The study will be performed at one institution, the University of Texas Medical Branch.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized clinical trial in which patients will be randomized to receive subacromial injection with either methylprednisolone or ketorolac.
Masking: Double (Participant, Investigator)
Masking Description: Neither the treating physician nor the patient will have access to drug-related details. Data will only be retrieved by the coordinating institution's research coordinator.
Primary Purpose: Treatment
Official Title: Subacromial Injection of Methylprednisolone Versus Ketorolac to Treat Shoulder Impingement: a Double-blind Randomized Controlled Trial
Estimated Study Start Date : June 15, 2019
Estimated Primary Completion Date : May 15, 2020
Estimated Study Completion Date : June 15, 2020


Arm Intervention/treatment
Active Comparator: Ketorolac
Assigned patients will receive a subacromial injection of ketorolac 60mg (2ml + 8ml lidocaine 1%)
Drug: Ketorolac Tromethamine
2ml of injectable Ketorolac (30mg/ml) will be mixed with 8ml of lidocaine HCL (1% without epinephrine) and delivered into the subacromial joint (total of 60mg of active substance in 10ml).
Other Name: Toradol

Active Comparator: Methylprednisolone
Assigned patients will receive a subacromial injection of methylprednisolone 80mg (1ml + 9ml lidocaine 1%)
Drug: Methylprednisolone Acetate
1ml of injectable Methylprednisolone (80mg/ml) will be mixed with 9ml of lidocaine HCL (1% without epinephrine) and delivered into the subacromial joint (total of 80mg of active substance in 10ml)
Other Name: DepoMedrol




Primary Outcome Measures :
  1. American Shoulder and Elbow Surgeon (ASES) [ Time Frame: 12 weeks ]
    The ASES is a self-assessment score, ranging between 0 and 100 (0 indicating the worst shoulder condition and 100 indicating the best shoulder condition), applicable for use in patients with shoulder pathology.


Secondary Outcome Measures :
  1. American Shoulder and Elbow Surgeon (ASES) [ Time Frame: 2 weeks ]
    The ASES is a self-assessment score, ranging between 0 and 100 (0 indicating the worst shoulder condition and 100 indicating the best shoulder condition), applicable for use in patients with shoulder pathology.

  2. American Shoulder and Elbow Surgeon (ASES) [ Time Frame: 4 weeks ]
    The ASES is a self-assessment score, ranging between 0 and 100, (0 indicating the worst shoulder condition and 100 indicating the best shoulder condition), applicable for use in patients with shoulder pathology.

  3. Range of Motion (ROM) [ Time Frame: 12 weeks ]
    The range of motion is a function-related measure, that reflects the extent of shoulder movement (measured in degrees, in forward flexion, and abduction with internal/external rotation of the shoulder)



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >18 years
  • Severe or recalcitrant shoulder impingement syndrome
  • Subacromial injection is a therapeutic option

Exclusion Criteria:

  • Allergy or intolerance to steroids within less than 1 month
  • Allergy or intolerance to NSAIDs within less than 1 month
  • Pregnancy
  • Breastfeeding
  • Pre-existing asthma
  • Uncontrolled psychiatric illness
  • Previous shoulder injection within the past 3 months
  • Evidence of confounding shoulder pathology on imaging
  • History of a full-thickness rotator cuff tear
  • Ipsilateral cervical radiculopathy
  • Moderate to severe glenohumeral arthritis
  • Systemic inflammatory conditions
  • Kidney disease
  • Liver disease
  • Gastrointestinal ulcer
  • Bleeding disorder
  • 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
  • Evidence of shoulder instability

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): NCT03913702


Contacts
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Contact: Marc El Beaino, MD, MSc 409-747-3207 maelbeai@utmb.edu

Locations
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United States, Texas
Universtiy of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555
Contact: Marc El Beaino, M.D., M.Sc.         
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
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Principal Investigator: Jeremy Somerson, MD University of Texas

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Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT03913702     History of Changes
Other Study ID Numbers: UTMB IRB #: 18-0156
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: At the end of this investigation, IPD-related results will be tabulated and submitted to clinictrials.gov to report. This would help evaluate the effects and safety of interventions administered.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: 20 weeks from the last patient enrollment
Access Criteria: At the end of this investigation, all results will be tabulated and submitted to clinictrials.gov to report.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by The University of Texas Medical Branch, Galveston:
Ketorolac
Methylprednisolone
Subacromial impingement syndrome

Additional relevant MeSH terms:
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Ketorolac
Ketorolac Tromethamine
Rotator Cuff Injuries
Shoulder Impingement Syndrome
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Joint Diseases
Musculoskeletal Diseases
Lidocaine
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents