search
Back to results

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

Primary Purpose

DeQuervains Tenosynovitis, Lateral Epicondylitis, Tennis Elbow

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ketorolac
Dexamethasone
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for DeQuervains Tenosynovitis focused on measuring DeQuervains Tenosynovitis, Lateral Epicondylitis, Tennis Elbow, Trigger Finger, Tenosynovitis, Inflammatory Disease, Dexamethasone, Ketorolac, Toradol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm Receiving Dexamethasone Injection

Arm Receiving Ketorolac Injection

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Trigger Finger Treatment Group: EQVAS Score
The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.
Trigger Finger Treatment Group: EQVAS Score
The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.
Trigger Finger Treatment Group: EQVAS Score
The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.
Trigger Finger Treatment Group: EQVAS Score
The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.
Trigger Finger Treatment Group: EQVAS Score
The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.
Trigger Finger Treatment Group: QuickDASH Functional Scores
The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) 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.
Trigger Finger Treatment Group: QuickDASH Functional Scores
The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) 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.
Trigger Finger Treatment Group: QuickDASH Functional Scores
The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) 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.
Trigger Finger Treatment Group: QuickDASH Functional Scores
The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) 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.
Trigger Finger Treatment Group: QuickDASH Functional Scores
The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) 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.
Trigger Finger Treatment Group: EuroQuol-5D (EQ-5D) Functional Score
The EQ-5D (EuroQol five-dimension scale) 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.
Trigger Finger Treatment Group: EuroQuol-5D (EQ-5D) Functional Score
The EQ-5D (EuroQol five-dimension scale) 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.
Trigger Finger Treatment Group: EuroQuol-5D (EQ-5D) Functional Score
The EQ-5D (EuroQol five-dimension scale) 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.
Trigger Finger Treatment Group: EuroQuol-5D (EQ-5D) Functional Score
The EQ-5D (EuroQol five-dimension scale) 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.
Trigger Finger Treatment Group: EuroQuol-5D (EQ-5D) Functional Score
The EQ-5D (EuroQol five-dimension scale) 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.
Trigger Finger Treatment Group: VAS Pain Scores
VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher the pain level. This will be recorded from the patient's written response at every visit.
Trigger Finger Treatment Group: VAS Pain Scores
VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher the pain level. This will be recorded from the patient's written response at every visit.
Trigger Finger Treatment Group: VAS Pain Scores
VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher the pain level. This will be recorded from the patient's written response at every visit.
Trigger Finger Treatment Group: VAS Pain Scores
VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher the pain level. This will be recorded from the patient's written response at every visit.
Trigger Finger Treatment Group: VAS Pain Scores
VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher the pain level. This will be recorded from the patient's written response at every visit.
Trigger Finger Treatment Group: Quinnell Grading Scores
The Quinnell grading system monitors for trigger symptom improvement with a range of 0 (minumum) to 4 (maximum) with a higher number corresponding to worse symptoms: 0-normal movement of finger; 1-uneven movement; 2-active correctible locking of digit; 3-passively correctible locking; 4-fixed deformity.
Trigger Finger Treatment Group: Quinnell Grading Scores
The Quinnell grading system monitors for trigger symptom improvement with a range of 0 (minumum) to 4 (maximum) with a higher number corresponding to worse symptoms: 0-normal movement of finger; 1-uneven movement; 2-active correctible locking of digit; 3-passively correctible locking; 4-fixed deformity.
Trigger Finger Treatment Group: Quinnell Grading Scores
The Quinnell grading system monitors for trigger symptom improvement with a range of 0 (minumum) to 4 (maximum) with a higher number corresponding to worse symptoms: 0-normal movement of finger; 1-uneven movement; 2-active correctible locking of digit; 3-passively correctible locking; 4-fixed deformity.
Trigger Finger Treatment Group: Quinnell Grading Scores
The Quinnell grading system monitors for trigger symptom improvement with a range of 0 (minumum) to 4 (maximum) with a higher number corresponding to worse symptoms: 0-normal movement of finger; 1-uneven movement; 2-active correctible locking of digit; 3-passively correctible locking; 4-fixed deformity.
Trigger Finger Treatment Group: Quinnell Grading Scores
The Quinnell grading system monitors for trigger symptom improvement with a range of 0 (minimum) to 4 (maximum) with a higher number corresponding to worse symptoms: 0-normal movement of finger; 1-uneven movement; 2-active correctible locking of digit; 3-passively correctible locking; 4-fixed deformity.
DeQuervain's Treatment Group: EQ-VAS Score
The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.
DeQuervain's Treatment Group: EQ-VAS Score
The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.
DeQuervain's Treatment Group: EQ-VAS Score
The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.
De Quervain's Treatment Group: QuickDASH Scores
The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) 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.
De Quervain's Treatment Group: QuickDASH Scores
The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) 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.
De Quervain's Treatment Group: QuickDASH Scores
The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) 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.
DeQuervain's Treatment Group: EQ-5D Score
The EQ-5D (EuroQol five-dimension scale) 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.
DeQuervain's Treatment Group: EQ-5D Score
The EQ-5D (EuroQol five-dimension scale) 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.
DeQuervain's Treatment Group: EQ-5D Score
The EQ-5D (EuroQol five-dimension scale) 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.
De Quervain's Treatment Group: VAS Pain Score
VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher and worse the pain level. This will be recorded from the patient's written response at every visit.
De Quervain's Treatment Group: VAS Pain Score
VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher and worse the pain level. This will be recorded from the patient's written response at every visit.
De Quervain's Treatment Group: VAS Pain Score
VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher and worse the pain level. This will be recorded from the patient's written response at every visit.
Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) Over Lateral Epicondyle
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.
Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) in Lateral Epicondyle
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.
Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) Over Lateral Epicondyle
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.
Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) With Resisted Wrist Extension
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 every visit.
Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) With Resisted Wrist Extension
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 every visit.
Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) With Resisted Wrist Extension
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 every visit.
Lateral Epicondylitis Treatment Group: QuickDASH Functional Scores
The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) 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.
Lateral Epicondylitis Treatment Group: QuickDASH Functional Scores
The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) 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.
Lateral Epicondylitis Treatment Group: QuickDASH Functional Scores
The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) 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.
Lateral Epicondylitis Treatment Group: EQ-5D Scores
The EQ-5D (EuroQol five-dimension scale) 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.
Lateral Epicondylitis Treatment Group: EQ-5D Scores
The EQ-5D (EuroQol five-dimension scale) 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.
Lateral Epicondylitis Treatment Group: EQ-5D Scores
The EQ-5D (EuroQol five-dimension scale) 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.
Lateral Epicondylitis Treatment Group: VAS Pain Score
VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher and worse the pain level. This will be recorded from the patient's written response at every visit.
Lateral Epicondylitis Treatment Group: VAS Pain Score
VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher and worse the pain level. This will be recorded from the patient's written response at every visit.
Lateral Epicondylitis Treatment Group: VAS Pain Score
VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher and worse the pain level. This will be recorded from the patient's written response at every visit.
Lateral Epicondylitis Treatment Group: EQ-VAS Score
The EQ-VAS (EuroQol visual analog scale) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.
Lateral Epicondylitis Treatment Group: EQ-VAS Score
The EQ-VAS (EuroQol visual analog scale) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.
Lateral Epicondylitis Treatment Group: EQ-VAS Score
The EQ-VAS (EuroQol visual analog scale) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.

Secondary Outcome Measures

Full Information

First Posted
September 18, 2014
Last Updated
October 8, 2020
Sponsor
NYU Langone Health
search

1. Study Identification

Unique Protocol Identification Number
NCT02266433
Brief Title
Dexamethasone Versus Ketorolac Injection for the Treatment of Local Inflammatory Hand and Upper Extremity Disorders
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 Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
due to PI's change to private practice
Study Start Date
August 2012 (undefined)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
July 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
DeQuervains Tenosynovitis, Lateral Epicondylitis, Tennis Elbow, Trigger Finger, Tenosynovitis, Inflammatory Disease
Keywords
DeQuervains Tenosynovitis, Lateral Epicondylitis, Tennis Elbow, Trigger Finger, Tenosynovitis, Inflammatory Disease, Dexamethasone, Ketorolac, Toradol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
245 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm Receiving Dexamethasone Injection
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Arm Receiving Ketorolac Injection
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Other Intervention Name(s)
Toradol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Trigger Finger Treatment Group: EQVAS Score
Description
The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.
Time Frame
Baseline
Title
Trigger Finger Treatment Group: EQVAS Score
Description
The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.
Time Frame
4 weeks
Title
Trigger Finger Treatment Group: EQVAS Score
Description
The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.
Time Frame
8 weeks
Title
Trigger Finger Treatment Group: EQVAS Score
Description
The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.
Time Frame
12 weeks
Title
Trigger Finger Treatment Group: EQVAS Score
Description
The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.
Time Frame
6 months
Title
Trigger Finger Treatment Group: QuickDASH Functional Scores
Description
The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) 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.
Time Frame
Baseline
Title
Trigger Finger Treatment Group: QuickDASH Functional Scores
Description
The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) 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.
Time Frame
4 weeks
Title
Trigger Finger Treatment Group: QuickDASH Functional Scores
Description
The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) 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.
Time Frame
8 weeks
Title
Trigger Finger Treatment Group: QuickDASH Functional Scores
Description
The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) 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.
Time Frame
12 weeks
Title
Trigger Finger Treatment Group: QuickDASH Functional Scores
Description
The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) 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.
Time Frame
6 months
Title
Trigger Finger Treatment Group: EuroQuol-5D (EQ-5D) Functional Score
Description
The EQ-5D (EuroQol five-dimension scale) 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.
Time Frame
Baseline
Title
Trigger Finger Treatment Group: EuroQuol-5D (EQ-5D) Functional Score
Description
The EQ-5D (EuroQol five-dimension scale) 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.
Time Frame
4 weeks
Title
Trigger Finger Treatment Group: EuroQuol-5D (EQ-5D) Functional Score
Description
The EQ-5D (EuroQol five-dimension scale) 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.
Time Frame
8 weeks
Title
Trigger Finger Treatment Group: EuroQuol-5D (EQ-5D) Functional Score
Description
The EQ-5D (EuroQol five-dimension scale) 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.
Time Frame
12 weeks
Title
Trigger Finger Treatment Group: EuroQuol-5D (EQ-5D) Functional Score
Description
The EQ-5D (EuroQol five-dimension scale) 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.
Time Frame
6 months
Title
Trigger Finger Treatment Group: VAS Pain Scores
Description
VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher the pain level. This will be recorded from the patient's written response at every visit.
Time Frame
Baseline
Title
Trigger Finger Treatment Group: VAS Pain Scores
Description
VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher the pain level. This will be recorded from the patient's written response at every visit.
Time Frame
4 weeks
Title
Trigger Finger Treatment Group: VAS Pain Scores
Description
VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher the pain level. This will be recorded from the patient's written response at every visit.
Time Frame
8 weeks
Title
Trigger Finger Treatment Group: VAS Pain Scores
Description
VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher the pain level. This will be recorded from the patient's written response at every visit.
Time Frame
12 weeks
Title
Trigger Finger Treatment Group: VAS Pain Scores
Description
VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher the pain level. This will be recorded from the patient's written response at every visit.
Time Frame
6 months
Title
Trigger Finger Treatment Group: Quinnell Grading Scores
Description
The Quinnell grading system monitors for trigger symptom improvement with a range of 0 (minumum) to 4 (maximum) with a higher number corresponding to worse symptoms: 0-normal movement of finger; 1-uneven movement; 2-active correctible locking of digit; 3-passively correctible locking; 4-fixed deformity.
Time Frame
Baseline
Title
Trigger Finger Treatment Group: Quinnell Grading Scores
Description
The Quinnell grading system monitors for trigger symptom improvement with a range of 0 (minumum) to 4 (maximum) with a higher number corresponding to worse symptoms: 0-normal movement of finger; 1-uneven movement; 2-active correctible locking of digit; 3-passively correctible locking; 4-fixed deformity.
Time Frame
4 weeks
Title
Trigger Finger Treatment Group: Quinnell Grading Scores
Description
The Quinnell grading system monitors for trigger symptom improvement with a range of 0 (minumum) to 4 (maximum) with a higher number corresponding to worse symptoms: 0-normal movement of finger; 1-uneven movement; 2-active correctible locking of digit; 3-passively correctible locking; 4-fixed deformity.
Time Frame
8 weeks
Title
Trigger Finger Treatment Group: Quinnell Grading Scores
Description
The Quinnell grading system monitors for trigger symptom improvement with a range of 0 (minumum) to 4 (maximum) with a higher number corresponding to worse symptoms: 0-normal movement of finger; 1-uneven movement; 2-active correctible locking of digit; 3-passively correctible locking; 4-fixed deformity.
Time Frame
12 weeks
Title
Trigger Finger Treatment Group: Quinnell Grading Scores
Description
The Quinnell grading system monitors for trigger symptom improvement with a range of 0 (minimum) to 4 (maximum) with a higher number corresponding to worse symptoms: 0-normal movement of finger; 1-uneven movement; 2-active correctible locking of digit; 3-passively correctible locking; 4-fixed deformity.
Time Frame
6 months
Title
DeQuervain's Treatment Group: EQ-VAS Score
Description
The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.
Time Frame
Baseline
Title
DeQuervain's Treatment Group: EQ-VAS Score
Description
The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.
Time Frame
4 weeks
Title
DeQuervain's Treatment Group: EQ-VAS Score
Description
The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.
Time Frame
8 weeks
Title
De Quervain's Treatment Group: QuickDASH Scores
Description
The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) 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.
Time Frame
Baseline
Title
De Quervain's Treatment Group: QuickDASH Scores
Description
The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) 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.
Time Frame
4 weeks
Title
De Quervain's Treatment Group: QuickDASH Scores
Description
The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) 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.
Time Frame
8 weeks
Title
DeQuervain's Treatment Group: EQ-5D Score
Description
The EQ-5D (EuroQol five-dimension scale) 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.
Time Frame
Baseline
Title
DeQuervain's Treatment Group: EQ-5D Score
Description
The EQ-5D (EuroQol five-dimension scale) 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.
Time Frame
4 weeks
Title
DeQuervain's Treatment Group: EQ-5D Score
Description
The EQ-5D (EuroQol five-dimension scale) 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.
Time Frame
8 weeks
Title
De Quervain's Treatment Group: VAS Pain Score
Description
VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher and worse the pain level. This will be recorded from the patient's written response at every visit.
Time Frame
Baseline
Title
De Quervain's Treatment Group: VAS Pain Score
Description
VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher and worse the pain level. This will be recorded from the patient's written response at every visit.
Time Frame
4 weeks
Title
De Quervain's Treatment Group: VAS Pain Score
Description
VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher and worse the pain level. This will be recorded from the patient's written response at every visit.
Time Frame
8 weeks
Title
Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) Over Lateral Epicondyle
Description
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.
Time Frame
Baseline
Title
Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) in Lateral Epicondyle
Description
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.
Time Frame
4 weeks
Title
Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) Over Lateral Epicondyle
Description
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.
Time Frame
8 weeks
Title
Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) With Resisted Wrist Extension
Description
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 every visit.
Time Frame
Baseline
Title
Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) With Resisted Wrist Extension
Description
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 every visit.
Time Frame
4 weeks
Title
Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) With Resisted Wrist Extension
Description
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 every visit.
Time Frame
8 weeks
Title
Lateral Epicondylitis Treatment Group: QuickDASH Functional Scores
Description
The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) 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.
Time Frame
Baseline
Title
Lateral Epicondylitis Treatment Group: QuickDASH Functional Scores
Description
The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) 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.
Time Frame
4 weeks
Title
Lateral Epicondylitis Treatment Group: QuickDASH Functional Scores
Description
The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) 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.
Time Frame
8 weeks
Title
Lateral Epicondylitis Treatment Group: EQ-5D Scores
Description
The EQ-5D (EuroQol five-dimension scale) 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.
Time Frame
Baseline
Title
Lateral Epicondylitis Treatment Group: EQ-5D Scores
Description
The EQ-5D (EuroQol five-dimension scale) 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.
Time Frame
4 weeks
Title
Lateral Epicondylitis Treatment Group: EQ-5D Scores
Description
The EQ-5D (EuroQol five-dimension scale) 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.
Time Frame
8 weeks
Title
Lateral Epicondylitis Treatment Group: VAS Pain Score
Description
VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher and worse the pain level. This will be recorded from the patient's written response at every visit.
Time Frame
Baseline
Title
Lateral Epicondylitis Treatment Group: VAS Pain Score
Description
VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher and worse the pain level. This will be recorded from the patient's written response at every visit.
Time Frame
4 weeks
Title
Lateral Epicondylitis Treatment Group: VAS Pain Score
Description
VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher and worse the pain level. This will be recorded from the patient's written response at every visit.
Time Frame
8 weeks
Title
Lateral Epicondylitis Treatment Group: EQ-VAS Score
Description
The EQ-VAS (EuroQol visual analog scale) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.
Time Frame
Baseline
Title
Lateral Epicondylitis Treatment Group: EQ-VAS Score
Description
The EQ-VAS (EuroQol visual analog scale) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.
Time Frame
4 weeks
Title
Lateral Epicondylitis Treatment Group: EQ-VAS Score
Description
The EQ-VAS (EuroQol visual analog scale) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Sapienza, MD
Organizational Affiliation
NYU Hospital for Joint Diseases; NYULMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs