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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03679793
Other study ID # Trigger thumb_Protocol_v02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2013
Est. completion date June 2015

Study information

Verified date September 2018
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Hong Kong Department of Orthopaedics and Traumatology, Prince of Wales Hospital, The Chinese University of Hong Kong Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total volume of local anaesthetics injected The total volume of local anaesthetics injected during operation Intra-operative
Primary Duration of surgery (in minutes) The time (in minutes) needed for operation Intra-operative
Primary Surgical site pain Visual analogue scale (VAS) was used to evaluate the pain at surgical site (0=no pain and 10=greatest pain) Intra-operative
Primary 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 Pre-operative
Primary 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 Post-op Day 7
Primary 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 Post-op Day 28
Primary 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 Post-op Day 90
Primary 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. Pre-operative
Primary 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. Post-op Day 7
Primary 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. Post-op Day 28
Primary 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. Post-op Day 90
Primary 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. Pre-operative
Primary 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. Post-op Day 7
Primary 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. Post-op Day 28
Primary 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. Post-op Day 90
Primary Pre-operative pain at rest Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain) Pre-opeartively
Primary Post-operative pain at rest Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain) Post-op Day 7
Primary Post-operative pain at rest Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain) Post-op Day 28
Primary Post-operative pain at rest Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain) Post-op Day 90
Primary Pre-operative pain on exertion Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain) Pre-operative
Primary Post-operative pain on exertion Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain) Post-op Day 7
Primary Post-operative pain on exertion Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain) Post-op Day 28
Primary Post-operative pain on exertion Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain) Post-op Day 90
Primary Satisfaction level after surgery Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery Post-op Day 7
Primary Satisfaction level after surgery Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery Post-op Day 28
Primary Satisfaction level after surgery Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery Post-op Day 91
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