Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06288685
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2024-02-17
Brief Title:
Percutaneous Trigger Finger Release Concomitant Steroid Injection Versus Percutaneous Trigger Finger Release Alone
Sponsor:
Police General Hospital Thailand
Organization:
Police General Hospital Thailand
Study Overview
Official Title:
Percutaneous Trigger Finger Release Concomitant Steroid Injection Versus Percutaneous Trigger Finger Release Alone
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Percutaneous A1 pulley release is a cost-effective and straightforward procedure with outcomes comparable to open A1 pulley release Postoperative pain is a prevalent concern Corticosteroid injection is a common nonoperative treatment for trigger finger providing favorable outcomes but associated with a notable risk of recurrence Numerous studies have explored the combined approach of percutaneous trigger finger release with corticosteroid injection However to date there is no report on early postoperative results
Objective
To conduct a comparative analysis of early postoperative outcomes between percutaneous A1 pulley release with steroid injection and percutaneous A1 pulley release alone
Study Design Methods
This study constitutes a randomized controlled trial involving patients with trigger finger who underwent percutaneous release surgery from October 2023 to January 2024 A total of 38 patients were enrolled with 18 assigned to the percutaneous A1 pulley release with steroid injection group and 20 to the percutaneous A1 pulley release alone group Postoperative assessments included pain scores using the Visual Analog Scale VAS evaluation of quality of life through the QuickDASH score qDASH patient satisfaction and complications
Percutaneous A1 pulley release is a cost-effective and straightforward procedure with outcomes comparable to open A1 pulley release Postoperative pain is a prevalent concern Corticosteroid injection is a common nonoperative treatment for trigger finger providing favorable outcomes but associated with a notable risk of recurrence Numerous studies have explored the combined approach of percutaneous trigger finger release with corticosteroid injection However to date there is no report on early postoperative results
Objective
To conduct a comparative analysis of early postoperative outcomes between percutaneous A1 pulley release with steroid injection and percutaneous A1 pulley release alone
Study Design Methods
This study constitutes a randomized controlled trial involving patients with trigger finger who underwent percutaneous release surgery from October 2023 to January 2024 A total of 38 patients were enrolled with 18 assigned to the percutaneous A1 pulley release with steroid injection group and 20 to the percutaneous A1 pulley release alone group Postoperative assessments included pain scores using the Visual Analog Scale VAS evaluation of quality of life through the QuickDASH score qDASH patient satisfaction and complications
Detailed Description:
Material and Methods
Study Population
Patients diagnosed with trigger finger aged 18 years or older and classified under Quinells grade 2 3 or 4 were included in the study Recruitment took place at the Outpatient Orthopedic Department of the Police General Hospital between October 2023 and January 2024 Exclusion criteria encompassed individuals with a history of prior hand surgery Dupuytrens disease type 1 diabetes previous phalangeal fractures recent steroid injection within the last month and autoimmune diseases
Group allocation and Randomization
Patients were enrolled and randomized into two groups percutaneous A1 pulley release with steroid injection Group A and percutaneous A1 pulley release alone Group B by utilizing computer generate randomization and the results were put in opaque sealed envelopes Informed consent was obtained from all participants and surgeries were performed by the same surgeon WJ
Surgical Technique
The surgical procedure followed Eastwoods method involving the following steps
1 Preparation of the sterile field
2 Injection of 1 lidocaine with epinephrine at the surgical site
3 Insertion of an 18-gauge needle following the tract from the previous injection
4 Patient extension of the finger to bring flexor tendons close to the skin moving the neurovascular structures away
5 Slow penetration of the needle until it is over the A1 pulley
6 Gentle flexion of the finger while observing the needle tip to prevent penetrating the flexor tendon
7 Rotation of the needle bevel into a longitudinal orientation to the flexor tendon
8 Release of the A1 pulley by moving the needle upward and downward parallel to the flexor tendon until complete release is achieved
9 Withdrawal of the needle while hyperextending the finger
10 Flexion and extension of the finger to check for triggering
11 Injection of triamcinolone 40mgml 1 ml in the study group
12 Closure of the wound with a small elastic dressing
Postoperative Protocols
Both groups received identical postoperative protocols including the same medications Augmentin Naproxen Tolperisone for 7 days Patients were encouraged for early finger range of motion without restriction
Outcome Measures
The primary outcome measure was pain score assessed by the VAS Secondary outcomes included quality of life measured by the qDASH score patient satisfaction and surgical complications
Follow-Up
All cases underwent follow-up via telephone on postoperative days 1 to 6 in the clinic during the first and second weeks and at 1 to 2 months postoperative
Statistical analysis In this study all data calculations were conducted using Stata software version 170 Group comparisons involved the application of Pearsons chi-squared test or Continuity Correction chi-squared test for categorical variables and the students t-test was employed for continuous variables Statistically significant differences were defined as those with a P-value 005
Study Population
Patients diagnosed with trigger finger aged 18 years or older and classified under Quinells grade 2 3 or 4 were included in the study Recruitment took place at the Outpatient Orthopedic Department of the Police General Hospital between October 2023 and January 2024 Exclusion criteria encompassed individuals with a history of prior hand surgery Dupuytrens disease type 1 diabetes previous phalangeal fractures recent steroid injection within the last month and autoimmune diseases
Group allocation and Randomization
Patients were enrolled and randomized into two groups percutaneous A1 pulley release with steroid injection Group A and percutaneous A1 pulley release alone Group B by utilizing computer generate randomization and the results were put in opaque sealed envelopes Informed consent was obtained from all participants and surgeries were performed by the same surgeon WJ
Surgical Technique
The surgical procedure followed Eastwoods method involving the following steps
1 Preparation of the sterile field
2 Injection of 1 lidocaine with epinephrine at the surgical site
3 Insertion of an 18-gauge needle following the tract from the previous injection
4 Patient extension of the finger to bring flexor tendons close to the skin moving the neurovascular structures away
5 Slow penetration of the needle until it is over the A1 pulley
6 Gentle flexion of the finger while observing the needle tip to prevent penetrating the flexor tendon
7 Rotation of the needle bevel into a longitudinal orientation to the flexor tendon
8 Release of the A1 pulley by moving the needle upward and downward parallel to the flexor tendon until complete release is achieved
9 Withdrawal of the needle while hyperextending the finger
10 Flexion and extension of the finger to check for triggering
11 Injection of triamcinolone 40mgml 1 ml in the study group
12 Closure of the wound with a small elastic dressing
Postoperative Protocols
Both groups received identical postoperative protocols including the same medications Augmentin Naproxen Tolperisone for 7 days Patients were encouraged for early finger range of motion without restriction
Outcome Measures
The primary outcome measure was pain score assessed by the VAS Secondary outcomes included quality of life measured by the qDASH score patient satisfaction and surgical complications
Follow-Up
All cases underwent follow-up via telephone on postoperative days 1 to 6 in the clinic during the first and second weeks and at 1 to 2 months postoperative
Statistical analysis In this study all data calculations were conducted using Stata software version 170 Group comparisons involved the application of Pearsons chi-squared test or Continuity Correction chi-squared test for categorical variables and the students t-test was employed for continuous variables Statistically significant differences were defined as those with a P-value 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 73256 | OTHER | Police General Hospital | None |