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 SystemTrigger 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
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