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Steroid injection is the first line treatment for trigger finger. Steroid injection is sometimes mixed with a local anesthetic.
The treatment of trigger finger involves an injection of corticosteroid. Corticosteroid treats the underlying inflammatory pathology. Some surgeons add lidocaine with epinephrine as a local anesthetic with the injection. Lidocaine with epinephrine is associated with a burning sensation and may be the primary pain associated with the injection. We hypothesize that a corticosteroid injection without lidocaine with epinephrine will be less painful, and equally effective in treating trigger finger
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corticosteroid with lidocaine with epinephrine | Active Comparator | This arm includes an injection mixture of corticosteroid and lidocaine with epinephrine |
|
| Corticosteroid with normal saline | Experimental | This arm includes a mixture of corticosteroid and normal saline. The purpose of normal saline is the keep the volume and concentration similar when compared to the injections containing lidocaine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corticosteroid with lidocaine with epinephrine | Drug | Trigger finger injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Outcome: Visual Analog Scale | Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever | Assessed 1 minute after injection (in clinic) |
| Pain Outcome: Visual Analog Scale | Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever | Assessed after 24 hours after injection (by phone) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37235 | United States |
IPD will not be shared with other researchers
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| ID | Title | Description |
|---|---|---|
| FG000 | Corticosteroid With Lidocaine With Epinephrine | This arm includes an injection mixture of corticosteroid and lidocaine with epinephrine Corticosteroid with lidocaine with epinephrine: Trigger finger injection |
| FG001 | Corticosteroid With Normal Saline | This arm includes a mixture of corticosteroid and normal saline. The purpose of normal saline is the keep the volume and concentration similar when compared to the injections containing lidocaine. Corticosteroid with normal saline: Trigger finger injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Corticosteroid With Lidocaine With Epinephrine | This arm includes an injection mixture of corticosteroid and lidocaine with epinephrine Corticosteroid with lidocaine with epinephrine: Trigger finger injection |
| BG001 | Corticosteroid With Normal Saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Outcome: Visual Analog Scale | Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever | Posted | Mean | Full Range | score on a scale | Assessed 1 minute after injection (in clinic) |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Corticosteroid With Lidocaine With Epinephrine | This arm includes an injection mixture of corticosteroid and lidocaine with epinephrine Corticosteroid with lidocaine with epinephrine: Trigger finger injection |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Drolet, MD | Vanderbilt University | (615) 322-2350 | brian.c.drolet@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 27, 2019 | Aug 28, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D052582 | Trigger Finger Disorder |
| ID | Term |
|---|---|
| D053682 | Tendon Entrapment |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D008012 | Lidocaine |
| D004837 | Epinephrine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D000083 | Acetanilides |
| D000813 | Anilides |
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| Corticosteroid with normal saline | Drug | Trigger finger injection |
|
This arm includes a mixture of corticosteroid and normal saline. The purpose of normal saline is the keep the volume and concentration similar when compared to the injections containing lidocaine. Corticosteroid with normal saline: Trigger finger injection |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Pain Outcome: Visual Analog Scale | Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever | Posted | Mean | Full Range | units on a scale | Assessed after 24 hours after injection (by phone) |
|
|
|
| 0 |
| 57 |
| 0 |
| 57 |
| 0 |
| 57 |
| EG001 | Corticosteroid With Normal Saline | This arm includes a mixture of corticosteroid and normal saline. The purpose of normal saline is the keep the volume and concentration similar when compared to the injections containing lidocaine. Corticosteroid with normal saline: Trigger finger injection | 0 | 53 | 0 | 53 | 0 | 53 |
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| D000577 |
| Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |