Trigger Finger Clinical Trial
Official title:
Trigger Finger Treatment - An Outcomes Study. Comparing 6 Traditional Treatment Techniques
| NCT number | NCT03847935 |
| Other study ID # | H-12583 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | December 10, 2007 |
| Est. completion date | December 8, 2012 |
| Verified date | February 2019 |
| Source | University of Massachusetts, Lowell |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Trigger finger is a common disorder of the hand which causes pain at the A1 pulley, inflammation, stiffness and/or snapping during movement. This observational study compared all of the possible treatments and combinations of treatments for trigger finger at the A1 pulley, including surgery, cortisone injections and hand therapy.
| Status | Completed |
| Enrollment | 86 |
| Est. completion date | December 8, 2012 |
| Est. primary completion date | December 8, 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - trigger finger in digit 2-5 Exclusion Criteria: - if prior treatment for trigger finger, or Trigger thumb |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University of Massachusetts, Lowell | University of Massachusetts, Worcester |
Lewis E, Fors L, Tharion WJ. Interrater and intrarater reliability of finger goniometric measurements. Am J Occup Ther. 2010 Jul-Aug;64(4):555-61. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Functional use using Quick DASH 6 weeks | Change from baseline to 6 weeks Quick DASH | Day 1, 6 weeks | |
| Primary | Change in Functional use using Quick DASH 3 months | Change from baseline to 3 months Quick DASH | Day 1, 3 months | |
| Primary | Change in Functional use using Quick DASH 6 months | Change from baseline to 6 months Quick DASH | Day 1, 6 months | |
| Primary | Change in Edema 6 weeks | Baseline to 6 weeks Circumferential measurement in centimeters of the proximal phalanx | day 1, 6 weeks | |
| Primary | Change in Edema 3 months | Baseline to 3 months weeks Circumferential measurement in centimeters of the proximal phalanx | day 1, 3 months | |
| Primary | Change in Edema 6 months | Baseline to 6 months weeks Circumferential measurement in centimeters of the proximal phalanx | day 1, 6 months | |
| Primary | Change in Pain on a likert scale 6 weeks | Baseline to 6 weeks pain on a 0-10 scale | 1 day, 6 weeks | |
| Primary | Change in Pain on a likert scale 3 months | Baseline to 3 months pain on a 0-10 scale | 1 day, 3 months | |
| Primary | Change in Pain on a likert scale 6 months | Baseline to 6 months pain on a 0-10 scale | 1 day, 6 months | |
| Primary | Change in Range of motion 6 weeks | Baseline to 6 weeks flexion and extension range of motion at metacarpophalangeal (MCP), proximal interphalangeal (PIP) and distal interphalangeal (DIP) using a finger goniometer. | 1 day, 6 weeks | |
| Primary | Change in Range of motion 3 months | Baseline to 3 months flexion and extension range of motion at metacarpophalangeal (MCP), proximal interphalangeal (PIP) and distal interphalangeal (DIP) using a finger goniometer. | 1 day, 3 months | |
| Primary | Change in Range of motion 6 months | Baseline to 6 months flexion and extension range of motion at metacarpophalangeal (MCP), proximal interphalangeal (PIP) and distal interphalangeal (DIP) using a finger goniometer. | 1 day, 6 months | |
| Primary | Change in Severity or Grade of triggering 6 weeks | Baseline to 6 weeks Using the scale by Patel and Bassini to measure the amount of triggering 1=normal joint, 6=locked in flexion | 1 day, 6 weeks | |
| Primary | Change in Severity or Grade of triggering 3 months | Baseline to 3 months Using the scale by Patel and Bassini to measure the amount of triggering 1=normal joint, 6=locked in flexion | 1 day, 3 months | |
| Primary | Change in Severity or Grade of triggering 6 months | Baseline to 6 months Using the scale by Patel and Bassini to measure the amount of triggering 1=normal joint, 6=locked in flexion | 1 day, 6 months |
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