Trigger ThumbNCT03679793
Study of Open and Percutaneous Release of Acquired Trigger Thumb
A study testing Open Release Group and Percutaneous Release Group in people with Trigger Thumb, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Trigger Thumb
- What is being tested?
- Open Release Group and Percutaneous Release Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- Aug 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- With history in rheumatoid arthritis
- Unable to give verbal or written consent.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Orthopaedics and Traumatology, Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong
About this study
Official title: 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.
- Conditions
- Trigger Thumb
- Being tested
- Open Release Group, Percutaneous Release Group
- Keywords
- Trigger Finger Disorder, Trigger Thumb, Minimally Invasive Surgical Procedures, Orthopedics
- Medical subject headings
- Trigger Finger Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Release GroupProcedure or surgery
Open surgical release of the A1 pulley is the gold standard of treating symptomatic trigger finger
Percutaneous Release GroupProcedure or surgery
Percutaneous release is a minimal invasive alternative surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| Open Release Group | Active comparator | Open surgical release of the A1 pulley is the gold standard of treating symptomatic trigger finger. Receives: Procedure: Open Release Group |
| Percutaneous Release Group | Experimental | Percutaneous release is a minimal invasive alternative surgical procedure Receives: Procedure: Percutaneous Release Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total volume of local anaesthetics injected
The total volume of local anaesthetics injected during operation
Measured: Intra-operative
Duration of surgery (in minutes)
The time (in minutes) needed for operation
Measured: Intra-operative
Surgical site pain
Visual analogue scale (VAS) was used to evaluate the pain at surgical site (0=no pain and 10=greatest pain)
Measured: Intra-operative
Active and passive range of motion (ROM) of interphalangeal joint (IPJ) and metacarpal-phalangeal joint (MPJ)
Pre-operative active and passive ROM of IPJ and MPJ was measured to determine the joint stiffness
Measured: Pre-operative
Active and passive range of motion (ROM) of interphalangeal joint (IPJ) and metacarpal-phalangeal joint (MPJ)
Active and passive ROM of IPJ and MPJ was measured post-operatively to determine the joint stiffness
Measured: Post-op Day 7
Active and passive range of motion (ROM) of interphalangeal joint (IPJ) and metacarpal-phalangeal joint (MPJ)
Active and passive ROM of IPJ and MPJ was measured post-operatively to determine the joint stiffness
Measured: Post-op Day 28
Active and passive range of motion (ROM) of interphalangeal joint (IPJ) and metacarpal-phalangeal joint (MPJ)
Active and passive ROM of IPJ and MPJ was measured post-operatively to determine the joint stiffness
Measured: Post-op Day 90
Pre-operative Kapandji score
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.
Measured: Pre-operative
Post-operative Kapandi score
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.
Measured: Post-op Day 7
Post-operative Kapandi score
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.
Measured: Post-op Day 28
Post-operative Kapandi score
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.
Measured: Post-op Day 90
Pre-operative Disabilities of the Arm, Shoulder and Hand (DASH) scores, including total, function, symptoms and work
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.
Measured: Pre-operative
Post-operative Disabilities of the Arm, Shoulder and Hand (DASH) scores, including total, function, symptoms and work
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.
Measured: Post-op Day 7
Post-operative Disabilities of the Arm, Shoulder and Hand (DASH) scores, including total, function, symptoms and work
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.
Measured: Post-op Day 28
Post-operative Disabilities of the Arm, Shoulder and Hand (DASH) scores, including total, function, symptoms and work
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.
Measured: Post-op Day 90
Pre-operative pain at rest
Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain)
Measured: Pre-opeartively
Post-operative pain at rest
Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain)
Measured: Post-op Day 7
Post-operative pain at rest
Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain)
Measured: Post-op Day 28
Post-operative pain at rest
Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain)
Measured: Post-op Day 90
Pre-operative pain on exertion
Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain)
Measured: Pre-operative
Post-operative pain on exertion
Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain)
Measured: Post-op Day 7
Post-operative pain on exertion
Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain)
Measured: Post-op Day 28
Post-operative pain on exertion
Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain)
Measured: Post-op Day 90
Satisfaction level after surgery
Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery
Measured: Post-op Day 7
Satisfaction level after surgery
Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery
Measured: Post-op Day 28
Satisfaction level after surgery
Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery
Measured: Post-op Day 91
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study startAug 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigger ThumbStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr TSE Wing Lim, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03679793
- Sponsor's protocol ID
- Trigger thumb_Protocol_v02
- Status last verified
- Sep 2018
- First submitted
- 3 Sep 2018
- Last updated
- 20 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All collected data were from patients from study site and strictly confidential
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Comparative Study of Open and Percutaneous Release of Acquired Trigger Thumb
- ClinicalTrials.gov ID
- NCT03679793
- Acronym / sponsor ID
- Trigger thumb_Protocol_v02
- Conditions
- Trigger Thumb
- Keywords
- Trigger Finger Disorder, Trigger Thumb, Minimally Invasive Surgical Procedures, Orthopedics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 20 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Release Group | Active comparator | Procedure: Open Release GroupOpen surgical release of the A1 pulley is the gold standard of treating symptomatic trigger finger. |
| Percutaneous Release Group | Experimental | Procedure: Percutaneous Release GroupPercutaneous release is a minimal invasive alternative surgical procedure |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- With history in rheumatoid arthritis
- Unable to give verbal or written consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open Release GroupOpen surgical release of the A1 pulley is the gold standard of treating symptomatic trigger finger | Procedure or surgery | Open Release Group |
| Percutaneous Release GroupPercutaneous release is a minimal invasive alternative surgical procedure | Procedure or surgery | Percutaneous Release Group |
Primary outcome
Total volume of local anaesthetics injected
Time frame: Intra-operative
The total volume of local anaesthetics injected during operation
Duration of surgery (in minutes)
Time frame: Intra-operative
The time (in minutes) needed for operation
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)
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
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
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
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
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.
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-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-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.
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.
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-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-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.
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)
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-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-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)
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)
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-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-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)
Satisfaction level after surgery
Time frame: Post-op Day 7
Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery
Satisfaction level after surgery
Time frame: Post-op Day 28
Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery
Satisfaction level after surgery
Time frame: Post-op Day 91
Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
- Individual participant dataSharing planned: No. All collected data were from patients from study site and strictly confidential
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open Release Group and Percutaneous Release Group in people with Trigger Thumb, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total volume of local anaesthetics injected (time frame: Intra-operative). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2018.