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Study closed; recruitment problems
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This research is being done to compare pain relief and efficacy of trigger finger injection using a combination of lidocaine/corticosteroid versus corticosteroid injection alone versus corticosteroid/saline combination.
This is a prospective, randomized study comparing pain relief and efficacy of trigger finger injection using a combination of lidocaine/corticosteroid versus corticosteroid injection alone versus corticosteroid/saline combination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corticosteroid alone (CS) Group | Active Comparator | 1 cc dexamethasone sodium phosphate (4mg/ml) injectable |
|
| Corticosteroid/Lidocaine (CSL) Group | Active Comparator | 1 cc dexamethasone sodium phosphate (4 mg/ml) injectable and 1 cc 1% Xylocaine (lidocaine) injectable |
|
| Corticosteroid/Saline (CSS) Group | Active Comparator | 1 cc dexamethasone sodium phosphate (4mg/ml) injectable and 1 cc 0.9% injectable Sodium Chloride (saline) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone Sodium Phosphate | Drug | adreno-cortical steroid anti-inflammatory drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| VAS | Visual Analogue Pain Scale (VAS) - measurement of pain on scale of 0 (least) to 10 (worst). | Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, at 6 weeks post-injection and also asked to recollect their pain at time of injection when seen at 6 weeks post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Triggering | Patients are asked how often their finger triggers - not at all, rarely, occasionally, or frequently at time intervals indicated in the outcome measure time frame. Count of participants for each of these answers was collected. | Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, and 6 weeks post-injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Taylor, MD | Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11476534 | Background | Saldana MJ. Trigger digits: diagnosis and treatment. J Am Acad Orthop Surg. 2001 Jul-Aug;9(4):246-52. doi: 10.5435/00124635-200107000-00004. | |
| 269967 | Background | Strom L. Trigger finger in diabetes. J Med Soc N J. 1977 Nov;74(11):951-4. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Corticosteroid Alone (CS) Group | 1 cc dexamethasone sodium phosphate (4mg/ml) injectable Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug |
| FG001 | Corticosteroid/Lidocaine (CSL) Group | 1 cc dexamethasone sodium phosphate (4 mg/ml) injectable and 1 cc 1% Xylocaine (lidocaine) injectable Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug Xylocaine: a local anesthetic agent |
| FG002 | Corticosteroid/Saline (CSS) Group | 1 cc dexamethasone sodium phosphate (4mg/ml) injectable and 1 cc 0.9% injectable Sodium Chloride (saline) Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug Sodium Chloride: Sodium chloride is a sterile, nonpryogenic solution for fluid and electrolyte replenishment |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Corticosteroid Alone (CS) Group | 1 cc dexamethasone sodium phosphate (4mg/ml) injectable Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug |
| BG001 | Corticosteroid/Lidocaine (CSL) Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | VAS | Visual Analogue Pain Scale (VAS) - measurement of pain on scale of 0 (least) to 10 (worst). | VAS was collected on all study participants except for the one patient (CSS group) who was withdrawn after enrollment and before any measurements were taken. | Posted | Mean | Standard Deviation | units on a scale | Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, at 6 weeks post-injection and also asked to recollect their pain at time of injection when seen at 6 weeks post-injection |
|
Adverse effects were assessed 1 minute, 10 minutes, and 6 weeks post-injction
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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 Alone (CS) Group | 1 cc dexamethasone sodium phosphate (4mg/ml) injectable Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug |
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Study closed prematurely on 1/25/2017 with 26 patients enrolled and 1 withdrawal.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenneth Taylor, M.D. | Penn State Milton S. Hershey Medical Center | (717) 531-5638 | ktaylor2@pennstatehealth.psu.edu |
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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 | May 20, 2015 | Jul 6, 2017 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 20, 2015 | Jul 6, 2017 | ICF_001.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 |
|---|---|
| C004180 | dexamethasone 21-phosphate |
| D008012 | Lidocaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| Xylocaine | Drug | a local anesthetic agent |
|
|
| Sodium Chloride | Drug | Sodium chloride is a sterile, nonpryogenic solution for fluid and electrolyte replenishment |
|
|
| Degree of Triggering | A Green classification number (0-4) is given to each subject pre-injection and at 6 weeks post-injection based on their degree of triggering. 0 = No triggering, no pain; 1 = Pre-triggering; pain, history of catching, but not demonstrable on physical examination; tenderness over the A1 pulley; 2 = Active; demonstrable catching, but the patient can actively extend the digit; 3= Passive; demonstrable catching requiring passive extension or inability to actively flex; and 4 = Contracture; demonstrable catching with a fixed flexion contracture of the PIP joint. | Patients are assessed pre-injection objectively by investigator and at 6 weeks post-injection subjectively via Patient Survey |
| Number of Participants With Adverse Effects | Incidence of adverse effects | Patients are assessed 1 minute post-injection, 10 minutes post-injection, and at 6 week post-injection. |
| 8973080 | Background | Kasdan ML, Leis VM, Lewis K, Kasdan AS. Trigger finger: not always work related. J Ky Med Assoc. 1996 Nov;94(11):498-9. |
| 2754207 | Background | Marks MR, Gunther SF. Efficacy of cortisone injection in treatment of trigger fingers and thumbs. J Hand Surg Am. 1989 Jul;14(4):722-7. doi: 10.1016/0363-5023(89)90199-8. |
| 1640148 | Background | Lambert MA, Morton RJ, Sloan JP. Controlled study of the use of local steroid injection in the treatment of trigger finger and thumb. J Hand Surg Br. 1992 Feb;17(1):69-70. doi: 10.1016/0266-7681(92)90014-s. |
| 7594291 | Background | Murphy D, Failla JM, Koniuch MP. Steroid versus placebo injection for trigger finger. J Hand Surg Am. 1995 Jul;20(4):628-31. doi: 10.1016/S0363-5023(05)80280-1. |
| 14599834 | Background | Maneerit J, Sriworakun C, Budhraja N, Nagavajara P. Trigger thumb: results of a prospective randomised study of percutaneous release with steroid injection versus steroid injection alone. J Hand Surg Br. 2003 Dec;28(6):586-9. doi: 10.1016/s0266-7681(03)00172-4. |
1 cc dexamethasone sodium phosphate (4 mg/ml) injectable and 1 cc 1% Xylocaine (lidocaine) injectable
Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug
Xylocaine: a local anesthetic agent
| BG002 | Corticosteroid/Saline (CSS) Group | 1 cc dexamethasone sodium phosphate (4mg/ml) injectable and 1 cc 0.9% injectable Sodium Chloride (saline) Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug Sodium Chloride: Sodium chloride is a sterile, nonpryogenic solution for fluid and electrolyte replenishment |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| 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 | Count of Participants | Participants |
|
1 cc dexamethasone sodium phosphate (4 mg/ml) injectable and 1 cc 1% Xylocaine (lidocaine) injectable Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug Xylocaine: a local anesthetic agent |
| OG002 | Corticosteroid/Saline (CSS) Group | 1 cc dexamethasone sodium phosphate (4mg/ml) injectable and 1 cc 0.9% injectable Sodium Chloride (saline) Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug Sodium Chloride: Sodium chloride is a sterile, nonpryogenic solution for fluid and electrolyte replenishment |
|
|
| Secondary | Presence of Triggering | Patients are asked how often their finger triggers - not at all, rarely, occasionally, or frequently at time intervals indicated in the outcome measure time frame. Count of participants for each of these answers was collected. | All participants from three groups were asked this question. Data was not collected on subject (CSS group) that withdrew from study after enrollment. | Posted | Count of Participants | Participants | Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, and 6 weeks post-injection |
|
|
|
| Secondary | Degree of Triggering | A Green classification number (0-4) is given to each subject pre-injection and at 6 weeks post-injection based on their degree of triggering. 0 = No triggering, no pain; 1 = Pre-triggering; pain, history of catching, but not demonstrable on physical examination; tenderness over the A1 pulley; 2 = Active; demonstrable catching, but the patient can actively extend the digit; 3= Passive; demonstrable catching requiring passive extension or inability to actively flex; and 4 = Contracture; demonstrable catching with a fixed flexion contracture of the PIP joint. | Data collected on all subjects enrolled except for one that was withdrawn after enrollment. | Posted | Count of Participants | Participants | Patients are assessed pre-injection objectively by investigator and at 6 weeks post-injection subjectively via Patient Survey |
|
|
|
| Secondary | Number of Participants With Adverse Effects | Incidence of adverse effects | Adverse effects was collected on all study participants except for the one patient who was withdrawn after enrollment (CSS group) | Posted | Count of Participants | Participants | Patients are assessed 1 minute post-injection, 10 minutes post-injection, and at 6 week post-injection. |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Corticosteroid/Lidocaine (CSL) Group | 1 cc dexamethasone sodium phosphate (4 mg/ml) injectable and 1 cc 1% Xylocaine (lidocaine) injectable Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug Xylocaine: a local anesthetic agent | 0 | 11 | 0 | 11 | 0 | 11 |
| EG002 | Corticosteroid/Saline (CSS) Group | 1 cc dexamethasone sodium phosphate (4mg/ml) injectable and 1 cc 0.9% injectable Sodium Chloride (saline) Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug Sodium Chloride: Sodium chloride is a sterile, nonpryogenic solution for fluid and electrolyte replenishment | 0 | 8 | 0 | 8 | 0 | 8 |
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| Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
|
| Triggering occasionally pre-injection |
|
| Triggering rarely pre-injection |
|
| Triggering not at all 1 minute post-injection |
|
| Triggering rarely 1 minute post-injection |
|
| Triggering occasionally 1 minute post-injection |
|
| Triggering frequently 1 minute post-injection |
|
| Triggering same as before 1 minute post-injection |
|
| Triggering not at all 10 minutes post-injection |
|
| Triggering rarely 10 minutes post-injection |
|
| Triggering occasionally 10 minutes post-injection |
|
| Triggering frequently 10 minutes post-injection |
|
| Triggering same as before 10 min. post-injection |
|
| Triggering not at all 6 wks post-injection |
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| Triggering rarely 6 wks post-injection |
|
| Triggering occasionally 6 weeks post-injection |
|
| Triggering frequently 6 wks post-injection |
|
| triggering same as before 6 wks post-injection |
|
|
| Green classification 2 (pre-injection) |
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| Green classification 3 (pre-injection) |
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| Green Classification 4 (pre-injection) |
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| Green classification 0 (6-weeks post-injection) |
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| Green classification 1 (6-weeks post-injection) |
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| Green classification 2 (6-weeks post-injection) |
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| Green classification 3 (6-weeks post-injection) |
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| Green classification 4 (6-weeks post-injection) |
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| Adverse effects 6 weeks post-injection |
|