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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date February 2019
Source University of Massachusetts, Lowell
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

Trigger finger is a common disorder of the hand which causes pain at the A1 pulley, inflammation, stiffness or snapping during movement. This can be very debilitating. Current treatment includes local steroid injection, oral NSAIDS, resting orthoses, physical or occupational therapy and surgical intervention. The aim of this prospective study with an observational design was to determine the outcome between surgical, hand therapy rehabilitation, and corticosteroid injection interventions for trigger finger. There were 6 treatment groups: surgery, corticosteroid injection, 1 visit of hand therapy for orthosis fabrication and therapeutic exercise, hand therapy in combination with cortisone injection, Modality hand therapy alone (ongoing visits) or with corticosteroid injections.


Recruitment information / eligibility

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

Study Design


Intervention

Procedure:
surgery
A1 pulley release of finger
corticosteroid injections
corticosteroid injection to A1 pulley
Other:
Hand Therapy
orthosis fabrication, therapeutic exercise for range of motion to digits, ice massage, nodule massage, patient education,
Modality Hand Therapy
orthosis fabrication, therapeutic exercise for range of motion to digits, ice massage, nodule massage, patient education, plus modalities such as ultrasound, iontophoresis

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Massachusetts, Lowell University of Massachusetts, Worcester

References & Publications (1)

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

Outcome

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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