Trigger Finger Treatment

February 18, 2019 updated by: ELewis, University of Massachusetts, Lowell

Trigger Finger Treatment - An Outcomes Study. Comparing 6 Traditional Treatment Techniques

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • trigger finger in digit 2-5

Exclusion Criteria:

  • if prior treatment for trigger finger, or Trigger thumb

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Surgery
Patients who underwent surgical release of A1 pulley
Procedure: surgery
A1 pulley release of finger
corticosteroid injections only
Patients who underwent local corticosteroid injections only, and no other treatment
Procedure: corticosteroid injections
corticosteroid injection to A1 pulley
hand therapy only occupational/physical
1 visit: orthosis fabrication, range of motion, nodule and ice massage.
Other: Hand Therapy
orthosis fabrication, therapeutic exercise for range of motion to digits, ice massage, nodule massage, patient education,
Other Names:
  • physical therapy
  • occupational 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 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,
Other Names:
  • physical therapy
  • occupational therapy
Modality Hand Therapy
Ongoing hand therapy treatment, which included the above plus modalities such as ultrasound or iontophoresis.
Other: 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
Injection and Modality Hand Therapy
Ccombination of local cortiscosteroid injection to the affected digit and ongoing hand therapy with modalities.
Procedure: corticosteroid injections
corticosteroid injection to A1 pulley
Other: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Functional use using Quick DASH 6 weeks
Time Frame: Day 1, 6 weeks
Change from baseline to 6 weeks Quick DASH
Day 1, 6 weeks
Change in Functional use using Quick DASH 3 months
Time Frame: Day 1, 3 months
Change from baseline to 3 months Quick DASH
Day 1, 3 months
Change in Functional use using Quick DASH 6 months
Time Frame: Day 1, 6 months
Change from baseline to 6 months Quick DASH
Day 1, 6 months
Change in Edema 6 weeks
Time Frame: day 1, 6 weeks
Baseline to 6 weeks Circumferential measurement in centimeters of the proximal phalanx
day 1, 6 weeks
Change in Edema 3 months
Time Frame: day 1, 3 months
Baseline to 3 months weeks Circumferential measurement in centimeters of the proximal phalanx
day 1, 3 months
Change in Edema 6 months
Time Frame: day 1, 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
Time Frame: 1 day, 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
Time Frame: 1 day, 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
Time Frame: 1 day, 6 months
Baseline to 6 months pain on a 0-10 scale
1 day, 6 months
Change in Range of motion 6 weeks
Time Frame: 1 day, 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
Time Frame: 1 day, 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
Time Frame: 1 day, 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
Time Frame: 1 day, 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
Time Frame: 1 day, 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
Time Frame: 1 day, 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Massachusetts, Lowell

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Massachusetts, Worcester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2007

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 8, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 8, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-12583

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There are no plans for sharing the IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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