The Effects of a Structured Hand Exercise Program on Trigger Finger: A Randomized Controlled Trial

March 28, 2025 updated by: Freddy Man Hin LAM, The Hong Kong Polytechnic University
To explore the effectiveness of a structured hand exercise program as a conservative treatment for trigger finger.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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.

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.
Interventional

Enrollment (Estimated)

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.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults with aged > 18 years old who are diagnosed with trigger finger
  • The Green classification grade 2 or grade 3
  • Pain (NPRS) equal or more than 4/10, during active triggering

Exclusion Criteria:

  • Pediatric or congenital trigger finger
  • Previously received physiotherapy, corticosteroid injection or surgery for trigger finger
  • Hand trauma, local infection or using systemic steroids due to other diseases

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: Exercise
Behavioral: Exercise
Participants will receive a 6-week structured hand exercise program. Participants will attend a face-to-face exercise session to learn all hand exercises. The exercise program will include: (1) Finger flexor stretching, (2) Tendon gliding exercise and (3) Isometric finger flexor exercise. A weekly tele follow-up will be done to participants in the experimental group
No Intervention: Control
Participants will receive no intervention.

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
Numeric Pain Rating Scale (NPRS) during triggering or movement
Time Frame: Baseline, 6 weeks after baseline, 10 weeks after baseline
NPRS consists of 11-point numeric scale from '0' (no pain) to '10' (worst pain imaginable). Participants rate the pain level based on their own pain intensity from 0-10
Baseline, 6 weeks after baseline, 10 weeks after baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Trigger finger stage in the Green Classification
Time Frame: Baseline, 6 weeks after baseline, 10 weeks after baseline
Green's classification for trigger finger: Grade 1 (A history of catching with local pain). Grade 2 (Demonstrable catching with normal active extension). Grade 3 (Demonstrable locking requiring passive extension). Grade 4 (Fixed flexion deformity)
Baseline, 6 weeks after baseline, 10 weeks after baseline
Frequency of triggering
Time Frame: Baseline, 6 weeks after baseline, 10 weeks after baseline
The frequency of triggering will be represented by the number of triggering events in ten active fists, from 0 to 10. Two questions will be asked: (1) What is the average number of triggering in ten active fists in the past one week? (2) What is the average number of painful triggering in ten active fists in the past one week?
Baseline, 6 weeks after baseline, 10 weeks after baseline
Functional score by Quick Disabilities of the Arm, Shoulder, and Hand Questionnaire (Hong Kong version)
Time Frame: Baseline, 6 weeks after baseline, 10 weeks after baseline
Quick Disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH) is a shorten version of the Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH). QuickDASH consisted of 11 items to measure physical function and symptoms in patients with upper limb disorders. DASH and QuickDASH were translated into Hong Kong version. Participants must complete at least 10 of the 11 items for a score to be calculated and the scores range from 0 (no disability) to 100 (most severe disability).
Baseline, 6 weeks after baseline, 10 weeks after baseline
Grip strength of the affected hand
Time Frame: Baseline, 6 weeks after baseline, 10 weeks after baseline
Grip strength will be assessed using the American Society of Hand Therapists (ASHT) protocol. Participants will be seated in a chair without arm rests, with hips and knees in 90 degrees. Shoulder holds in adduction and neutral rotation. Elbow holds in 90 degrees flexion with forearm in neutral rotation. Participants grip the dynamometer in 15-30 degrees wrist extension and 0-15 degrees of ulnar deviation. Participants will be asked to grip the dynamometer as hard as they can for 3 trials. The mean of the 3 trials will be recorded as the grip strength in kg.
Baseline, 6 weeks after baseline, 10 weeks after baseline
Structural changes using musculoskeletal ultrasound (A1 pulley thickness, flexor tendon thicknesses, A1 pulley lumen size)
Time Frame: Baseline, 6 weeks after baseline, 10 weeks after baseline
Musculoskeletal ultrasound with a linear transducer (12MHz probe) will be used to evaluate the structural outcome measures.
Baseline, 6 weeks after baseline, 10 weeks after baseline

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.
The Hong Kong Polytechnic University

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 (Estimated)

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.
April 15, 2025

Primary Completion (Estimated)

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.
January 1, 2026

Study Completion (Estimated)

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.
August 1, 2026

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).
March 28, 2025

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.
March 28, 2025

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.
April 4, 2025

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.
April 4, 2025

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.
March 28, 2025

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.
March 1, 2025

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.
  • HSEARS20241227004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study data can be provided via contacting the Principal Investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings