NCT03847935

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2007

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2007

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2012

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 20, 2019

Completed
Last Updated

February 20, 2019

Status Verified

February 1, 2019

Enrollment Period

5 years

First QC Date

February 8, 2019

Last Update Submit

February 18, 2019

Conditions

Keywords

treatment outcomehand therapyphysical therapyoccupational therapy

Outcome Measures

Primary Outcomes (15)

  • Change in Functional use using Quick DASH 6 weeks

    Change from baseline to 6 weeks Quick DASH

    Day 1, 6 weeks

  • Change in Functional use using Quick DASH 3 months

    Change from baseline to 3 months Quick DASH

    Day 1, 3 months

  • Change in Functional use using Quick DASH 6 months

    Change from baseline to 6 months Quick DASH

    Day 1, 6 months

  • Change in Edema 6 weeks

    Baseline to 6 weeks Circumferential measurement in centimeters of the proximal phalanx

    day 1, 6 weeks

  • Change in Edema 3 months

    Baseline to 3 months weeks Circumferential measurement in centimeters of the proximal phalanx

    day 1, 3 months

  • Change in Edema 6 months

    Baseline to 6 months weeks Circumferential measurement in centimeters of the proximal phalanx

    day 1, 6 months

  • Change in Pain on a likert scale 6 weeks

    Baseline to 6 weeks pain on a 0-10 scale

    1 day, 6 weeks

  • Change in Pain on a likert scale 3 months

    Baseline to 3 months pain on a 0-10 scale

    1 day, 3 months

  • Change in Pain on a likert scale 6 months

    Baseline to 6 months pain on a 0-10 scale

    1 day, 6 months

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (6)

Surgery

Patients who underwent surgical release of A1 pulley

Procedure: surgery

corticosteroid injections only

Patients who underwent local corticosteroid injections only, and no other treatment

Procedure: corticosteroid injections

hand therapy only occupational/physical

1 visit: orthosis fabrication, range of motion, nodule and ice massage.

Other: Hand Therapy

Injection and Hand therapy

This group of participants received a combination of corticosteroid injection in the affected finger and one visit of hand therapy.

Procedure: corticosteroid injectionsOther: Hand Therapy

Modality Hand Therapy

Ongoing hand therapy treatment, which included the above plus modalities such as ultrasound or iontophoresis.

Other: Modality Hand Therapy

Injection and Modality Hand Therapy

Ccombination of local cortiscosteroid injection to the affected digit and ongoing hand therapy with modalities.

Procedure: corticosteroid injectionsOther: Modality Hand Therapy

Interventions

surgeryPROCEDURE

A1 pulley release of finger

Surgery

corticosteroid injection to A1 pulley

Injection and Hand therapyInjection and Modality Hand Therapycorticosteroid injections only

orthosis fabrication, therapeutic exercise for range of motion to digits, ice massage, nodule massage, patient education,

Also known as: physical therapy, occupational therapy
Injection and Hand therapyhand therapy only occupational/physical

orthosis fabrication, therapeutic exercise for range of motion to digits, ice massage, nodule massage, patient education, plus modalities such as ultrasound, iontophoresis

Injection and Modality Hand TherapyModality Hand Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients undergoing medical treatment or hand therapy for trigger finger in digits #2-5 at the hand clinic. Patients were dropped from the study if they had changed to a different treatment.

You may qualify if:

  • trigger finger in digit 2-5

You may not qualify if:

  • if prior treatment for trigger finger, or Trigger thumb

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. doi: 10.5014/ajot.2010.09028.

    PMID: 20825126BACKGROUND

MeSH Terms

Conditions

Trigger Finger DisorderTendon Entrapment

Interventions

Surgical Procedures, OperativePhysical Therapy ModalitiesOccupational Therapy

Condition Hierarchy (Ancestors)

TendinopathyMuscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitationAftercareContinuity of Patient CarePatient Care

Study Officials

  • Erika S. Lewis, Ed.D

    Associate Professor, University of Massachusetts Lowell

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 8, 2019

First Posted

February 20, 2019

Study Start

December 10, 2007

Primary Completion

December 8, 2012

Study Completion

December 8, 2012

Last Updated

February 20, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

There are no plans for sharing the IPD