Study of Open and Percutaneous Release of Acquired Trigger Thumb

September 19, 2018 updated by: Dr TSE Wing Lim, Chinese University of Hong Kong

A Prospective Randomized Comparative Study of Open and Percutaneous Release of Acquired Trigger Thumb

Trigger finger, also known as trigger digit or stenosing tenovaginitis, is caused by a size mismatch between the flexor tendon and the A1 pulley, which is generally characterized by pain, swelling, the limitation of finger range of motion and a symptomatic locking or clicking sensation. Conservative treatment options include the application of non-steroidal anti-inflammatory drugs (NSAID), physiotherapy, electrotherapy, splinting and corticosteroid injection but not always effective with regard to frequent recurrence. Open surgical release of the A1 pulley remains the gold standard of treating symptomatic trigger finger. While percutaneous release is a minimal invasive alternative and gaining popularity for the index, middle ring and little fingers, investigations for the surgical efficacy on thumb is few and far between. Investigators believe that a carefully conducted operation with proper positioning of the thumb, wide-awake approach and meticulous technique can achieve similar efficacy and safety in terms of possibly less intraoperative pain, imperceptible scar and early return to daily activities and routine work.

The hypothesis of this study is that by using a proper positioning of thumb, wide awake approach and meticulous technique in conducting percutaneous release of trigger thumb can achieve similar efficacy and safety compared to that of open release surgical method. Moreover, percutaneous release of trigger thumb can generate less intraoperative pain, imperceptible scar and promote early return to routine work.

Hence, the objective of this study is to investigate and compare the safety, effectiveness and outcome of percutaneous release versus traditional open release for trigger thumbs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

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 Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Department of Orthopaedics and Traumatology, Prince of Wales Hospital, The Chinese University of Hong Kong

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of trigger thumb with Green's staging graded 2-4
  • Patients were unresponsive to conservative treatments for more than 3 months (Nonsteroidal anti-inflammatory drugs, physiotherapy, splinting, or injection of steroid)

Exclusion Criteria:

  • With history in rheumatoid arthritis
  • Unable to give verbal or written consent.

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
Active Comparator: Open Release Group
Open surgical release of the A1 pulley is the gold standard of treating symptomatic trigger finger.
Procedure: Open Release Group
Open surgical release of the A1 pulley is the gold standard of treating symptomatic trigger finger
Experimental: Percutaneous Release Group
Percutaneous release is a minimal invasive alternative surgical procedure
Procedure: Percutaneous Release Group
Percutaneous release is a minimal invasive alternative surgical procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total volume of local anaesthetics injected
Time Frame: Intra-operative
The total volume of local anaesthetics injected during operation
Intra-operative
Duration of surgery (in minutes)
Time Frame: Intra-operative
The time (in minutes) needed for operation
Intra-operative
Surgical site pain
Time Frame: Intra-operative
Visual analogue scale (VAS) was used to evaluate the pain at surgical site (0=no pain and 10=greatest pain)
Intra-operative
Active and passive range of motion (ROM) of interphalangeal joint (IPJ) and metacarpal-phalangeal joint (MPJ)
Time Frame: Pre-operative
Pre-operative active and passive ROM of IPJ and MPJ was measured to determine the joint stiffness
Pre-operative
Active and passive range of motion (ROM) of interphalangeal joint (IPJ) and metacarpal-phalangeal joint (MPJ)
Time Frame: Post-op Day 7
Active and passive ROM of IPJ and MPJ was measured post-operatively to determine the joint stiffness
Post-op Day 7
Active and passive range of motion (ROM) of interphalangeal joint (IPJ) and metacarpal-phalangeal joint (MPJ)
Time Frame: Post-op Day 28
Active and passive ROM of IPJ and MPJ was measured post-operatively to determine the joint stiffness
Post-op Day 28
Active and passive range of motion (ROM) of interphalangeal joint (IPJ) and metacarpal-phalangeal joint (MPJ)
Time Frame: Post-op Day 90
Active and passive ROM of IPJ and MPJ was measured post-operatively to determine the joint stiffness
Post-op Day 90
Pre-operative Kapandji score
Time Frame: Pre-operative
Kapandji score is a tool useful for assessing the opposition of the thumb, based on where on their hand the patient is able to touch with the tip of their thumb.
Pre-operative
Post-operative Kapandi score
Time Frame: Post-op Day 7
Kapandji score is a tool useful for assessing the opposition of the thumb, based on where on their hand the patient is able to touch with the tip of their thumb.
Post-op Day 7
Post-operative Kapandi score
Time Frame: Post-op Day 28
Kapandji score is a tool useful for assessing the opposition of the thumb, based on where on their hand the patient is able to touch with the tip of their thumb.
Post-op Day 28
Post-operative Kapandi score
Time Frame: Post-op Day 90
Kapandji score is a tool useful for assessing the opposition of the thumb, based on where on their hand the patient is able to touch with the tip of their thumb.
Post-op Day 90
Pre-operative Disabilities of the Arm, Shoulder and Hand (DASH) scores, including total, function, symptoms and work
Time Frame: Pre-operative
The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.
Pre-operative
Post-operative Disabilities of the Arm, Shoulder and Hand (DASH) scores, including total, function, symptoms and work
Time Frame: Post-op Day 7
The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.
Post-op Day 7
Post-operative Disabilities of the Arm, Shoulder and Hand (DASH) scores, including total, function, symptoms and work
Time Frame: Post-op Day 28
The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.
Post-op Day 28
Post-operative Disabilities of the Arm, Shoulder and Hand (DASH) scores, including total, function, symptoms and work
Time Frame: Post-op Day 90
The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.
Post-op Day 90
Pre-operative pain at rest
Time Frame: Pre-opeartively
Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain)
Pre-opeartively
Post-operative pain at rest
Time Frame: Post-op Day 7
Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain)
Post-op Day 7
Post-operative pain at rest
Time Frame: Post-op Day 28
Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain)
Post-op Day 28
Post-operative pain at rest
Time Frame: Post-op Day 90
Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain)
Post-op Day 90
Pre-operative pain on exertion
Time Frame: Pre-operative
Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain)
Pre-operative
Post-operative pain on exertion
Time Frame: Post-op Day 7
Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain)
Post-op Day 7
Post-operative pain on exertion
Time Frame: Post-op Day 28
Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain)
Post-op Day 28
Post-operative pain on exertion
Time Frame: Post-op Day 90
Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain)
Post-op Day 90
Satisfaction level after surgery
Time Frame: Post-op Day 7
Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery
Post-op Day 7
Satisfaction level after surgery
Time Frame: Post-op Day 28
Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery
Post-op Day 28
Satisfaction level after surgery
Time Frame: Post-op Day 91
Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery
Post-op Day 91

Collaborators and Investigators

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

Sponsor

Chinese University of Hong Kong

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)

August 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

September 3, 2018

First Submitted That Met QC Criteria

September 19, 2018

First Posted (Actual)

September 20, 2018

Study Record Updates

Last Update Posted (Actual)

September 20, 2018

Last Update Submitted That Met QC Criteria

September 19, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Trigger thumb_Protocol_v02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

All collected data were from patients from study site and strictly confidential

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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