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

Information source: New York University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: DeQuervains Tenosynovitis; Lateral Epicondylitis; Tennis Elbow; Trigger Finger; Tenosynovitis; Inflammatory Disease

Intervention: Ketorolac (Drug); Dexamethasone (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: New York University School of Medicine

Official(s) and/or principal investigator(s):
Anthony Sapienza, MD, Principal Investigator, Affiliation: NYU Hospital for Joint Diseases; NYULMC

Overall contact:
Anthony Sapienza, MD, Phone: 212-598-6697, Email: anthony.sapienza@nyumc.org

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Primary outcome:

Trigger Finger Treatment Group: Change in objective triggering based on Quinnell Grading System

Trigger Finger Treatment Group: Change in QuickDASH functional scores

Trigger Finger Treatment Group: Change in EuroQuol-5D (EQ-5D) Functional Score

Trigger Finger Treatment Group: Change in VAS Pain Scores

DeQuervain's Treatment Group: Change in Pain at 1st Dorsal Compartment

DeQuervain's Treatment Group: Change in Finkelstein Test

De Quervain's Treatment Group: Change in QuickDASH scores

DeQuervain's Treatment Group: Change in EQ-5D scores

De Quervain's Treatment Group: Change in VAS Pain score

Lateral Epicondylitis Treatment Group: Change in pain over lateral epicondyle

Lateral Epicondylitis Treatment Group: Change in pain with resisted wrist extension

Lateral Epicondylitis Treatment Group: Change in QuickDASH functional scores

Lateral Epicondylitis Treatment Group: Change in EQ-5D scores

Lateral Epicondylitis Treatment Group: Change in VAS Pain Scores

Secondary outcome: Change in Blood Glucose Levels 24 and 48 hours after Treatment Injection

Detailed description: Objectives: 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). Number of Subjects: 780 total subjects: • 260 subjects in each of the 3 treatment groups (De Quervain's tenosynovitis, trigger fingers and lateral epicondylitis) Diagnosis and Main Inclusion Criteria Subjects 18 years or older, with any of the following diagnoses: De Quervain's tenosynovitis, trigger fingers, or lateral epicondylitis Study Product, Dose, Route, Regimen: Peritendinous soft tissue injection for De Quervain's tenosynovitis, trigger fingers and lateral epicondylitis: • 1 mL of ketorolac (30mg/mL) and 0. 5 mL (5mg) of 1% lidocaine Duration of administration Single administration, with a second injection permitted only once as subject desires due to no major clinical response at the 4 or 8-week follow-up. Reference therapy: Standard of care peritendinous soft tissue injection for De Quervain's tenosynovitis, trigger fingers, and lateral epicondylitis: • 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0. 5 mL (5mg) of 1% lidocaine Statistical Methodology: The sample size as stated above was derived by a power analysis. A power analysis indicated that a total sample size of 200 patients randomized equally (1: 1 randomization) to each treatment arm (i. e trigger finger, De Quervain's disease, and tennis elbow) without any blocking or stratification would provide 80% statistical power (alpha=.05, beta=0. 20) to detect a 10% difference in mean Quick Disabilities of the Arm, Shoulder and Hand (quickDASH) scores between cohorts assuming a common standard deviation of 25% (effect size = 10/25 = 0. 4). To account for an estimated 30% loss to follow-up, the investigators plan to enroll a total of 260 patients per treatment arm (i. e. trigger finger, De Quervain's disease, and tennis elbow). In total, there will be approximately 780 patients enrolled among all treatment arms. 1. 1 Background Many orthopaedic hand disorders are comprised of different forms of tendonitis, tenosynovitis, and arthritis. The inflammatory processes of these disorders cause discomfort and functional impairment for patients. Decreasing the inflammatory response by use of splinting, physiotherapy, systemic anti-inflammatory agents, and local anti-inflammatory injections helps to alleviate some or all of the discomfort (2-4). Steroid injections are not entirely benign, and complications include tendon ruptures, subcutaneous fat atrophy, skin pigmentation changes, cartilage damage, and hyperglycemic responses in diabetics (9-11, 22-23). Studies have shown that ketorolac, a non-steroidal anti-inflammatory agent has a potent anti-inflammatory effect comparable to corticosteroids and a strong analgesic effect allowing for reduced opioid consumption postoperatively (7, 8). One could argue that the potent anti-inflammatory properties of ketorolac could be used to substitute for local corticosteroid injections in treating certain hand disorders. Given the side-effect profile for corticosteroids it may be beneficial to treat inflammatory disorders with local ketorolac injections. Nonsteroidal anti-inflammatory agents also have their known systemic adverse effects including gastric ulceration and intestinal bleeding as well as impairment of renal function. Most of these side effects are theoretically avoided with local tissue injections. 1. 2 Study Drugs 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. 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. Lidocaine: Lidocaine is a local anesthetic of the amide type, and will be used within its labeled indication for this study: production of local or regional anesthesia by infiltration techniques such as percutaneous injection. It is to be given as concomitant therapy with both the investigational agent, ketorolac injection, and the standard of care therapy, dexamethasone injection.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Anthony Sapienza, MD, Phone: 212-598-6697, Email: anthony.sapienza@nyumc.org

New York University School of Medicine, New York, New York 10016, United States; Recruiting
Marina Godina, Email: godinm01@nyumc.org
Cara-Lee Fontaine, Email: cara-lee.fontaine@nyumc.org
Anthony Sapienza, MD, Principal Investigator
Kenneth Brock, BS, Sub-Investigator
Sergio Glait, MD, Sub-Investigator
Additional Information

Starting date: August 2012
Last updated: October 16, 2014

Page last updated: August 23, 2015

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