Dexamethasone Versus Ketorolac Injection for the Treatment of Local Inflammatory Hand and Upper Extremity Disorders

• ClinicalTrials.gov Identifier: NCT02266433
• Recruitment Status: Terminated
• First Posted: October 17, 2014
• Last Update Posted: May 6, 2019
• Sponsor: NYU Langone Health
• Information provided by (Responsible Party): NYU Langone Health

Study Description

Brief Summary:

The primary objective of this study is to compare local corticosteroid hand and elbow injections to placebo or ketorolac to determine if there is an equal or better reduction of symptoms for common orthopaedic upper extremity disorders including: De Quervain's tenosynovitis, trigger fingers, and tennis elbow (lateral epicondylitis). The investigators will enroll 780 subjects, divided equally into three arms for each disease process, and compare the efficacy of Ketorolac injections to Dexamethasone injections by measuring patient's functional status scores and pain scores at 0 weeks, 4 weeks, 8 weeks, 12 weeks, and 6 month followup periods, prospectively over time.

Condition or disease	Intervention/treatment	Phase
DeQuervains Tenosynovitis; Lateral Epicondylitis; Tennis Elbow; Trigger Finger; Tenosynovitis; Inflammatory Disease	Drug: Ketorolac; Drug: Dexamethasone	Phase 3

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Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 244 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: A Double-blinded, Prospective, Randomized, Controlled Trial Comparing Dexamethasone Versus Ketorolac Injection for the Treatment of Local Inflammatory Hand and Upper Extremity Disorders
• Study Start Date: August 2012
• Actual Primary Completion Date: July 1, 2018
• Actual Study Completion Date: July 1, 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Arm Receiving Dexamethasone Injection; Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.	Drug: Dexamethasone; Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised individuals, pregnant females, persons with allergy to steroids, individuals with systemic fungal infections, and individuals with cerebral malaria. It is contra-indicated in systemic fungal infections, and hypersensitivity to any component of this product, including sulfites.
Experimental: Arm Receiving Ketorolac Injection; Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.	Drug: Ketorolac; The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study Ketorolac is a non-steroidal anti-inflammatory drug (NSAID). The approved indication for Ketorolac is for the short-term (≤5 days) management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. It is highly protein bound (99%) and is largely metabolized by the liver. In it's approved indication it is contraindicated for those with renal impairment, active peptic ulcer disease, pregnant or nursing females, individuals with NSAID hypersensitivity, or individuals at high risk for bleeding/clotting disorders.; Other Name: Toradol

Outcome Measures

Primary Outcome Measures :

1. Trigger Finger Treatment Group: Change in objective triggering based on Quinnell Grading System [ Time Frame: 0, 4, 8, 12 weeks, 6 months ]
   Quinnell Grading system is assessed by the treating clinician at each visit upon physical exam of the patient's affected hand: 0-normal movement of finger; 1-uneven movement; 2-active correctible locking of digit; 3-passively correctible locking; 4-fixed deformity (15). This is recorded on the followup data sheets every time.
2. Trigger Finger Treatment Group: Change in QuickDASH functional scores [ Time Frame: 0, 4, 8, 12 weeks and 6 months ]
   The QuickDASH is an 11-question standardized survey used to assess a patient's overall functional status and is widely used in the practice of orthopaedic surgery as an analog measurement of a patient's functional ability. Scores range from 0-100, with 100 being the most poor functionality and 0 being the best. This will be assessed at every visit by having the patient fill out the survey and our team calculating the score at the end of the visit.
3. Trigger Finger Treatment Group: Change in EuroQuol-5D (EQ-5D) Functional Score [ Time Frame: 0, 4, 8, 12 weeks and 6 months ]
   The EQ-5D is a 5 question survey with 3 potential responses per question, based on measuring a patient's overall quality of life. The responses are compiled into a numerical score ranging from 1 to -0.11, with 1 being the best and -0.11 being the worst in terms of quality of life. This survey will be administered to patients at each visit, along with the other surveys.
4. Trigger Finger Treatment Group: Change in VAS Pain Scores [ Time Frame: 0, 4, 8, 12 weeks and 6 months ]
   VAS pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. This will be recorded from the patient's written response at every visit.
5. DeQuervain's Treatment Group: Change in Pain at 1st Dorsal Compartment [ Time Frame: 0, 4, 8, 12 weeks and 6 months ]
   The clinician will examine the patient and determine objectively if there is pain or no pain upon palpation of the first dorsal extensor compartment. Pain is recorded as a 1, and no pain is recorded as a 0, for this categorical variable measured at each visit.
6. DeQuervain's Treatment Group: Change in Finkelstein Test [ Time Frame: 0, 4, 8, 12 weeks and 6 months ]
   The clinician will perform the finkelstein exam maneuver by ulnarly deviating the affected wrist, flexing the patient's thumb, and palpating the first dorsal compartment to see if pain is elicited. Pain is a positive response, marked as 1. No pain is a negative response, marked as zero. This is assessed at every visit, including baseline, like all other assessments mentioned here.
7. De Quervain's Treatment Group: Change in QuickDASH scores [ Time Frame: 0, 4, 8, 12, week and 6 months ]
   The QuickDASH is an 11-question standardized survey used to assess a patient's overall functional status and is widely used in the practice of orthopaedic surgery as an analog measurement of a patient's functional ability. Scores range from 0-100, with 100 being the most poor functionality and 0 being the best. This will be assessed at every visit by having the patient fill out the survey and our team calculating the score at the end of the visit.
8. DeQuervain's Treatment Group: Change in EQ-5D scores [ Time Frame: 0, 4, 8, 12, weeks and 6 months ]
   The EQ-5D is a 5 question survey with 3 potential responses per question, based on measuring a patient's overall quality of life. The responses are compiled into a numerical score ranging from 1 to -0.11, with 1 being the best and -0.11 being the worst in terms of quality of life. This survey will be administered to patients at each visit, along with the other surveys.
9. De Quervain's Treatment Group: Change in VAS Pain score [ Time Frame: 0, 4, 8, 12 weeks and 6 months ]
   VAS pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. This will be recorded from the patient's written response at every visit.
10. Lateral Epicondylitis Treatment Group: Change in pain over lateral epicondyle [ Time Frame: 0, 4, 8, 12 weeks and 6 months ]
    Clinician will examine the patient and palpate over the lateral epicondyle. Presence of pain is a positive test, recorded as 1. Absence of pain is a negative test, recorded as 0. This is done at every visit.
11. Lateral Epicondylitis Treatment Group: Change in pain with resisted wrist extension [ Time Frame: 0, 4, 8, 12 weeks and 6 months ]
    The clinician examines the patient and asks patient to extend wrist against resistance by the clinician. Production of pain is a positive test, recorded as 1. Absence of pain is a negative test, recorded as 0. This is done at ever visit.
12. Lateral Epicondylitis Treatment Group: Change in QuickDASH functional scores [ Time Frame: 0, 4, 8, 12, weeks and 6 months ]
    The QuickDASH is an 11-question standardized survey used to assess a patient's overall functional status and is widely used in the practice of orthopaedic surgery as an analog measurement of a patient's functional ability. Scores range from 0-100, with 100 being the most poor functionality and 0 being the best. This will be assessed at every visit by having the patient fill out the survey and our team calculating the score at the end of the visit
13. Lateral Epicondylitis Treatment Group: Change in EQ-5D scores [ Time Frame: 0, 4, 8, 12 weeks and 6 months ]
    The EQ-5D is a 5 question survey with 3 potential responses per question, based on measuring a patient's overall quality of life. The responses are compiled into a numerical score ranging from 1 to -0.11, with 1 being the best and -0.11 being the worst in terms of quality of life. This survey will be administered to patients at each visit, along with the other surveys.
14. Lateral Epicondylitis Treatment Group: Change in VAS Pain Scores [ Time Frame: 0, 4, 8, 12 weeks and 6 months ]
    VAS pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. This will be recorded from the patient's written response at every visit.

Secondary Outcome Measures :

1. Change in Blood Glucose Levels 24 and 48 hours after Treatment Injection [ Time Frame: 24 and 48 hours after all visits at 0, 4, 8, 12 weeks and 6 months ]
   Any diabetic patients who monitor their blood sugar levels will be asked to keep a log of their blood sugar levels measured at least once in the 24 hours after a visit, and at least once in the 48 hours after the visit, for each protocol visit. This is done for ALL groups, and both treatment arms.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Patients must be diagnosed with at least one of the following: trigger finger, de quervain's tenosynovitis, or tennis elbow (lateral epicondylitis)
• Patients age 18 years of age or older from all racial/ethnic types
• Patient who are both males and females
• Study participants will include any New York University employee or students as these individuals also can get hand and upper extremity pathology. It will be specifically reiterated to them that their academic status or grades, or employment will not be affected by their decision to participate in this study. Record of the participation cannot be linked to an academic record.

Exclusion Criteria:

• Patients had previous steroid injection at the site in question within 90 days of enrollment
• Patients with a history of gastric ulcers, renal impairment, allergy/hypersensitivity to non-steroidal anti-inflammatory (NSAID) or lidocaine derivative medications, immunocompromised patients (HIV/AIDs) and pregnant females

Contacts and Locations

Locations

United States, New York

New York University School of Medicine

New York, New York, United States, 10016

Sponsors and Collaborators

NYU Langone Health

Investigators

• Principal Investigator: Anthony Sapienza, MD; NYU Hospital for Joint Diseases; NYULMC

More Information

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT02266433 History of Changes
• Other Study ID Numbers: 12-00878
• First Posted: October 17, 2014
• Last Update Posted: May 6, 2019
• Last Verified: May 2019

• 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 NYU Langone Health:

DeQuervains Tenosynovitis; Lateral Epicondylitis; Tennis Elbow; Trigger Finger; Tenosynovitis; Inflammatory Disease; Dexamethasone; Ketorolac; Toradol

Additional relevant MeSH terms:

Tennis Elbow; Trigger Finger Disorder; Tenosynovitis; Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Arm Injuries; Wounds and Injuries; Tendon Injuries; Tendon Entrapment; Dexamethasone; Dexamethasone acetate; Ketorolac; Ketorolac Tromethamine; BB 1101; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action