- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02266433
Dexamethasone Versus Ketorolac Injection for the Treatment of Local Inflammatory Hand and Upper Extremity Disorders
A Double-blinded, Prospective, Randomized, Controlled Trial Comparing Dexamethasone Versus Ketorolac Injection for the Treatment of Local Inflammatory Hand and Upper Extremity Disorders
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- New York University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm Receiving Dexamethasone Injection
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. |
Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised individuals, pregnant females, persons with allergy to steroids, individuals with systemic fungal infections, and individuals with cerebral malaria. It is contra-indicated in systemic fungal infections, and hypersensitivity to any component of this product, including sulfites. |
Experimental: Arm Receiving Ketorolac Injection
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. |
The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study Ketorolac is a non-steroidal anti-inflammatory drug (NSAID). The approved indication for Ketorolac is for the short-term (≤5 days) management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. It is highly protein bound (99%) and is largely metabolized by the liver. In it's approved indication it is contraindicated for those with renal impairment, active peptic ulcer disease, pregnant or nursing females, individuals with NSAID hypersensitivity, or individuals at high risk for bleeding/clotting disorders.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Trigger Finger Treatment Group: EQVAS Score
Time Frame: Baseline
|
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.
|
Baseline
|
Trigger Finger Treatment Group: EQVAS Score
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Trigger Finger Treatment Group: EQVAS Score
Time Frame: 8 weeks
|
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.
|
8 weeks
|
Trigger Finger Treatment Group: EQVAS Score
Time Frame: 12 weeks
|
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.
|
12 weeks
|
Trigger Finger Treatment Group: EQVAS Score
Time Frame: 6 months
|
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.
|
6 months
|
Trigger Finger Treatment Group: QuickDASH Functional Scores
Time Frame: Baseline
|
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.
|
Baseline
|
Trigger Finger Treatment Group: QuickDASH Functional Scores
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Trigger Finger Treatment Group: QuickDASH Functional Scores
Time Frame: 8 weeks
|
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.
|
8 weeks
|
Trigger Finger Treatment Group: QuickDASH Functional Scores
Time Frame: 12 weeks
|
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.
|
12 weeks
|
Trigger Finger Treatment Group: QuickDASH Functional Scores
Time Frame: 6 months
|
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.
|
6 months
|
Trigger Finger Treatment Group: EuroQuol-5D (EQ-5D) Functional Score
Time Frame: Baseline
|
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.
|
Baseline
|
Trigger Finger Treatment Group: EuroQuol-5D (EQ-5D) Functional Score
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Trigger Finger Treatment Group: EuroQuol-5D (EQ-5D) Functional Score
Time Frame: 8 weeks
|
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.
|
8 weeks
|
Trigger Finger Treatment Group: EuroQuol-5D (EQ-5D) Functional Score
Time Frame: 12 weeks
|
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.
|
12 weeks
|
Trigger Finger Treatment Group: EuroQuol-5D (EQ-5D) Functional Score
Time Frame: 6 months
|
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.
|
6 months
|
Trigger Finger Treatment Group: VAS Pain Scores
Time Frame: Baseline
|
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.
|
Baseline
|
Trigger Finger Treatment Group: VAS Pain Scores
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Trigger Finger Treatment Group: VAS Pain Scores
Time Frame: 8 weeks
|
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.
|
8 weeks
|
Trigger Finger Treatment Group: VAS Pain Scores
Time Frame: 12 weeks
|
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.
|
12 weeks
|
Trigger Finger Treatment Group: VAS Pain Scores
Time Frame: 6 months
|
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.
|
6 months
|
Trigger Finger Treatment Group: Quinnell Grading Scores
Time Frame: Baseline
|
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.
|
Baseline
|
Trigger Finger Treatment Group: Quinnell Grading Scores
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Trigger Finger Treatment Group: Quinnell Grading Scores
Time Frame: 8 weeks
|
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.
|
8 weeks
|
Trigger Finger Treatment Group: Quinnell Grading Scores
Time Frame: 12 weeks
|
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.
|
12 weeks
|
Trigger Finger Treatment Group: Quinnell Grading Scores
Time Frame: 6 months
|
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.
|
6 months
|
DeQuervain's Treatment Group: EQ-VAS Score
Time Frame: Baseline
|
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.
|
Baseline
|
DeQuervain's Treatment Group: EQ-VAS Score
Time Frame: 4 weeks
|
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.
|
4 weeks
|
DeQuervain's Treatment Group: EQ-VAS Score
Time Frame: 8 weeks
|
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.
|
8 weeks
|
De Quervain's Treatment Group: QuickDASH Scores
Time Frame: Baseline
|
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.
|
Baseline
|
De Quervain's Treatment Group: QuickDASH Scores
Time Frame: 4 weeks
|
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.
|
4 weeks
|
De Quervain's Treatment Group: QuickDASH Scores
Time Frame: 8 weeks
|
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.
|
8 weeks
|
DeQuervain's Treatment Group: EQ-5D Score
Time Frame: Baseline
|
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.
|
Baseline
|
DeQuervain's Treatment Group: EQ-5D Score
Time Frame: 4 weeks
|
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.
|
4 weeks
|
DeQuervain's Treatment Group: EQ-5D Score
Time Frame: 8 weeks
|
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.
|
8 weeks
|
De Quervain's Treatment Group: VAS Pain Score
Time Frame: Baseline
|
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.
|
Baseline
|
De Quervain's Treatment Group: VAS Pain Score
Time Frame: 4 weeks
|
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.
|
4 weeks
|
De Quervain's Treatment Group: VAS Pain Score
Time Frame: 8 weeks
|
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.
|
8 weeks
|
Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) Over Lateral Epicondyle
Time Frame: Baseline
|
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.
|
Baseline
|
Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) in Lateral Epicondyle
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) Over Lateral Epicondyle
Time Frame: 8 weeks
|
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.
|
8 weeks
|
Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) With Resisted Wrist Extension
Time Frame: Baseline
|
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.
|
Baseline
|
Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) With Resisted Wrist Extension
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) With Resisted Wrist Extension
Time Frame: 8 weeks
|
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.
|
8 weeks
|
Lateral Epicondylitis Treatment Group: QuickDASH Functional Scores
Time Frame: Baseline
|
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.
|
Baseline
|
Lateral Epicondylitis Treatment Group: QuickDASH Functional Scores
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Lateral Epicondylitis Treatment Group: QuickDASH Functional Scores
Time Frame: 8 weeks
|
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.
|
8 weeks
|
Lateral Epicondylitis Treatment Group: EQ-5D Scores
Time Frame: Baseline
|
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.
|
Baseline
|
Lateral Epicondylitis Treatment Group: EQ-5D Scores
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Lateral Epicondylitis Treatment Group: EQ-5D Scores
Time Frame: 8 weeks
|
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.
|
8 weeks
|
Lateral Epicondylitis Treatment Group: VAS Pain Score
Time Frame: Baseline
|
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.
|
Baseline
|
Lateral Epicondylitis Treatment Group: VAS Pain Score
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Lateral Epicondylitis Treatment Group: VAS Pain Score
Time Frame: 8 weeks
|
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.
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8 weeks
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Lateral Epicondylitis Treatment Group: EQ-VAS Score
Time Frame: Baseline
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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.
|
Baseline
|
Lateral Epicondylitis Treatment Group: EQ-VAS Score
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Lateral Epicondylitis Treatment Group: EQ-VAS Score
Time Frame: 8 weeks
|
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.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anthony Sapienza, MD, NYU Hospital for Joint Diseases; NYULMC
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Wounds and Injuries
- Musculoskeletal Diseases
- Muscular Diseases
- Tendon Injuries
- Tendinopathy
- Arm Injuries
- Elbow Tendinopathy
- Tendon Entrapment
- Tennis Elbow
- Tenosynovitis
- Trigger Finger Disorder
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dexamethasone
- Ketorolac
Other Study ID Numbers
- 12-00878
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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