A Phase 3 interventional study of Ketorolac and Dexamethasone in DeQuervains Tenosynovitis, Lateral Epicondylitis and Tennis Elbow, sponsored by NYU Langone Health. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-02.
Sponsored by NYU Langone Health · Phase 3, Interventional, and Treatment
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.
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:
Study Product, Dose, Route, Regimen: Peritendinous soft tissue injection for De Quervain's tenosynovitis, trigger fingers and lateral epicondylitis:
Reference therapy: Standard of care peritendinous soft tissue injection for De Quervain's tenosynovitis, trigger fingers, and lateral epicondylitis:
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.
296 studies on the registry are indexed under Tennis Elbow; 64 are open to participants now.
This study's enrollment of 245 is above the median of 50 across 262 interventional studies indexed under Tennis Elbow.
Browse Tennis Elbow studies →NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Also known as: Toradol
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.
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.
Time frame: Baseline
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.
Time frame: 4 weeks
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.
Time frame: 8 weeks
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.
Time frame: 12 weeks
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.
Time frame: 6 months
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.
Time frame: Baseline
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.
Time frame: 4 weeks
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.
Time frame: 8 weeks
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.
Time frame: 12 weeks
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.
Time frame: 6 months
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.
Time frame: Baseline
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.
Time frame: 4 weeks
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.
Time frame: 8 weeks
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.
Time frame: 12 weeks
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.
Time frame: 6 months
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.
Time frame: Baseline
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.
Time frame: 4 weeks
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.
Time frame: 8 weeks
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.
Time frame: 12 weeks
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.
Time frame: 6 months
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.
Time frame: Baseline
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.
Time frame: 4 weeks
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.
Time frame: 8 weeks
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.
Time frame: 12 weeks
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.
Time frame: 6 months
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.
Time frame: Baseline
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.
Time frame: 4 weeks
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.
Time frame: 8 weeks
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.
Time frame: Baseline
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.
Time frame: 4 weeks
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.
Time frame: 8 weeks
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.
Time frame: Baseline
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.
Time frame: 4 weeks
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.
Time frame: 8 weeks
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.
Time frame: Baseline
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.
Time frame: 4 weeks
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.
Time frame: 8 weeks
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.
Time frame: Baseline
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.
Time frame: 4 weeks
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.
Time frame: 8 weeks
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.
Time frame: Baseline
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.
Time frame: 4 weeks
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.
Time frame: 8 weeks
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.
Time frame: Baseline
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.
Time frame: 4 weeks
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.
Time frame: 8 weeks
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.
Time frame: Baseline
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.
Time frame: 4 weeks
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.
Time frame: 8 weeks
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.
Time frame: Baseline
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.
Time frame: 4 weeks
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.
Time frame: 8 weeks
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.
Time frame: Baseline
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.
Time frame: 4 weeks
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.
Time frame: 8 weeks
Patients will be enrolled from the private office of orthopaedic hand surgeons (Dr. Paksima and Dr. Sapienza) and the resident hand clinic at NYU Hospital for Joint Diseases held at the 23rd street clinic.
| Milestone | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Started | 127 | 118 |
| Completed | 68 | 65 |
| Not completed | 59 | 53 |
| Withdrew: Lost to follow-up | 54 | 46 |
| Withdrew: Withdrawal by subject | 5 | 7 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Trigger Finger Treatment Group: EQVAS Score | 82.07 ± 16.25 | 82.30 ± 13.70 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Trigger Finger Treatment Group: EQVAS Score | 82.79 ± 13.48 | 82.56 ± 13.77 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Trigger Finger Treatment Group: EQVAS Score | 82.17 ± 13.31 | 81.61 ± 13.65 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Trigger Finger Treatment Group: EQVAS Score | 93.50 ± 6.35 | 83.91 ± 7.82 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Trigger Finger Treatment Group: EQVAS Score | 90.25 ± 8.48 | 75.79 ± 14.39 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Trigger Finger Treatment Group: QuickDASH Functional Scores | 28.56 ± 19.46 | 27.38 ± 20.71 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Trigger Finger Treatment Group: QuickDASH Functional Scores | 28.73 ± 20.03 | 27.56 ± 18.75 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Trigger Finger Treatment Group: QuickDASH Functional Scores | 23.61 ± 17.55 | 21.88 ± 15.43 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Trigger Finger Treatment Group: QuickDASH Functional Scores | 15.65 ± 18.01 | 28.27 ± 28.29 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Trigger Finger Treatment Group: QuickDASH Functional Scores | 21.04 ± 21.08 | 25.90 ± 22.35 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Trigger Finger Treatment Group: EuroQuol-5D (EQ-5D) Functional Score | 0.77 ± 0.13 | 0.78 ± 0.16 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Trigger Finger Treatment Group: EuroQuol-5D (EQ-5D) Functional Score | 0.76 ± 0.16 | 0.78 ± 0.14 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Trigger Finger Treatment Group: EuroQuol-5D (EQ-5D) Functional Score | 0.83 ± 0.10 | 0.82 ± 0.12 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Trigger Finger Treatment Group: EuroQuol-5D (EQ-5D) Functional Score | 0.87 ± 0.10 | 0.81 ± 0.19 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Trigger Finger Treatment Group: EuroQuol-5D (EQ-5D) Functional Score | 0.88 ± 0.10 | 0.77 ± 0.18 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Trigger Finger Treatment Group: VAS Pain Scores | 5.41 ± 2.65 | 4.79 ± 2.47 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Trigger Finger Treatment Group: VAS Pain Scores | 4.20 ± 2.74 | 4.48 ± 2.63 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Trigger Finger Treatment Group: VAS Pain Scores | 4.23 ± 2.72 | 3.53 ± 2.82 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Trigger Finger Treatment Group: VAS Pain Scores | 2.25 ± 2.25 | 2.68 ± 2.63 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Trigger Finger Treatment Group: VAS Pain Scores | 1.75 ± 3.49 | 3.07 ± 3.57 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Trigger Finger Treatment Group: Quinnell Grading Scores | 1.67 ± 0.76 | 1.79 ± 0.86 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Trigger Finger Treatment Group: Quinnell Grading Scores | 1.37 ± 0.89 | 1.55 ± 1.08 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Trigger Finger Treatment Group: Quinnell Grading Scores | 1.63 ± 1.00 | 1.07 ± 0.87 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Trigger Finger Treatment Group: Quinnell Grading Scores | 1.13 ± 0.99 | 1.22 ± 1.09 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Trigger Finger Treatment Group: Quinnell Grading Scores | 1.14 ± 1.46 | 0.67 ± 0.89 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| DeQuervain's Treatment Group: EQ-VAS Score | 82.16 ± 13.91 | 79.45 ± 19.00 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| DeQuervain's Treatment Group: EQ-VAS Score | 26.19 ± 18.58 | 52.93 ± 14.55 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| DeQuervain's Treatment Group: EQ-VAS Score | 84.2 ± 12.68 | 87.33 ± 7.77 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| De Quervain's Treatment Group: QuickDASH Scores | 39.05 ± 19.51 | 47.40 ± 16.61 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| De Quervain's Treatment Group: QuickDASH Scores | 26.19 ± 18.58 | 52.93 ± 14.55 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| De Quervain's Treatment Group: QuickDASH Scores | 23.61 ± 16.18 | 68.34 ± 19.64 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| DeQuervain's Treatment Group: EQ-5D Score | 0.75 ± 0.13 | 0.75 ± 0.15 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| DeQuervain's Treatment Group: EQ-5D Score | 0.83 ± 0.1 | 0.71 ± 0.18 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| DeQuervain's Treatment Group: EQ-5D Score | 0.85 ± 0.08 | 0.74 ± 0.13 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| De Quervain's Treatment Group: VAS Pain Score | 7.03 ± 2.02 | 6.94 ± 1.99 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| De Quervain's Treatment Group: VAS Pain Score | 4.35 ± 2.28 | 5.35 ± 3.02 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| De Quervain's Treatment Group: VAS Pain Score | 3.05 ± 2.24 | 7.33 ± 0.58 |
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.
| Participants | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) Over Lateral Epicondyle | — | 1 |
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.
| Participants | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) in Lateral Epicondyle | — | 1 |
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.
| Participants | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) Over Lateral Epicondyle | — | 0 |
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.
| Participants | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) With Resisted Wrist Extension | — | 1 |
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.
| Participants | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) With Resisted Wrist Extension | — | 1 |
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.
| Participants | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) With Resisted Wrist Extension | — | 0 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Lateral Epicondylitis Treatment Group: QuickDASH Functional Scores | — | 14 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Lateral Epicondylitis Treatment Group: QuickDASH Functional Scores | — | 8 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Lateral Epicondylitis Treatment Group: QuickDASH Functional Scores | — | 9 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Lateral Epicondylitis Treatment Group: EQ-5D Scores | — | 0.83 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Lateral Epicondylitis Treatment Group: EQ-5D Scores | — | 0.83 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Lateral Epicondylitis Treatment Group: EQ-5D Scores | — | 1 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Lateral Epicondylitis Treatment Group: VAS Pain Score | — | 6 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Lateral Epicondylitis Treatment Group: VAS Pain Score | — | 4 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Lateral Epicondylitis Treatment Group: VAS Pain Score | — | 3 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Lateral Epicondylitis Treatment Group: EQ-VAS Score | — | 89 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Lateral Epicondylitis Treatment Group: EQ-VAS Score | — | 85 |
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.
| score on a scale | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Lateral Epicondylitis Treatment Group: EQ-VAS Score | — | 90 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm Receiving Dexamethasone Injection | 0/127 (0%) | 0/127 (0%) | 2/127 (1.6%) |
| Arm Receiving Ketorolac Injection | 0/118 (0%) | 0/118 (0%) | 0/118 (0%) |
| Event | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection |
|---|---|---|
| Skin discolorationSkin and subcutaneous tissue disorders | 1/127 | 0/118 |
| Redness and itchingSkin and subcutaneous tissue disorders | 1/127 | 0/118 |
| Age, Categorical(Participants) | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 93 | 88 | 181 |
| >=65 years | 34 | 30 | 64 |
| Sex: Female, Male(Participants) | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection | Total |
|---|---|---|---|
| Female | 84 | 83 | 167 |
| Male | 43 | 35 | 78 |
| Race and Ethnicity Not Collected(Participants) | Arm Receiving Dexamethasone Injection | Arm Receiving Ketorolac Injection | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
The record gives a start of Aug 2012, a primary completion of Jul 2018 and a completion of Jul 2018. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2020, 2 years 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ketorolac