- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06911762
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
Study Type
Interventional
Enrollment (Estimated)
76
Phase
- 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
- Name: Freddy Man Hin LAM, PhD
- Phone Number: +852 2766-6720
- Email: freddy-mh.lam@polyu.edu.hk
Study Locations
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Hong Kong, Hong Kong
- The Hong Kong Polytechnic University
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Contact:
- Chi Hong Chung
- Phone Number: +852 2766-7091
- Email: kenneth.ch.chung@polyu.edu.hk
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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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: 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
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No Intervention: Control
Participants will receive no intervention.
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What is the study measuring?
Primary Outcome Measures
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
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Baseline, 6 weeks after baseline, 10 weeks after baseline
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Secondary Outcome Measures
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)
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Baseline, 6 weeks after baseline, 10 weeks after baseline
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Frequency of triggering
Time Frame: Baseline, 6 weeks after baseline, 10 weeks after baseline
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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?
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Baseline, 6 weeks after baseline, 10 weeks after baseline
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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
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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).
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Baseline, 6 weeks after baseline, 10 weeks after baseline
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Grip strength of the affected hand
Time Frame: Baseline, 6 weeks after baseline, 10 weeks after baseline
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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.
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Baseline, 6 weeks after baseline, 10 weeks after baseline
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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
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Musculoskeletal ultrasound with a linear transducer (12MHz probe) will be used to evaluate the structural outcome measures.
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Baseline, 6 weeks after baseline, 10 weeks after baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
April 15, 2025
Primary Completion (Estimated)
January 1, 2026
Study Completion (Estimated)
August 1, 2026
Study Registration Dates
First Submitted
March 28, 2025
First Submitted That Met QC Criteria
March 28, 2025
First Posted (Actual)
April 4, 2025
Study Record Updates
Last Update Posted (Actual)
April 4, 2025
Last Update Submitted That Met QC Criteria
March 28, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
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