A Phase 3 interventional study of percutaneous A1 pulley release and Triamcinolone in Trigger Finger, Percutaneous A1 Pulley Release and Steroid Injection, sponsored by Police General Hospital, Thailand. Completed at 1 site in Thailand. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-12.
Sponsored by Police General Hospital, Thailand · Phase 3, Interventional, and Treatment
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.
Material and Methods
Study Population:
Patients diagnosed with trigger finger, aged 18 years or older, and classified under Quinell's 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, Dupuytren's 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 Eastwood's method [ ], involving the following steps:
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 17.0). Group comparisons involved the application of Pearson's chi-squared test or Continuity Correction chi-squared test for categorical variables, and the student's t-test was employed for continuous variables. Statistically significant differences were defined as those with a P-value \< 0.05.
Exclusion Criteria:
percutaneous A1 pulley release with Triamcinolone injection
Procedure: percutaneous A1 pulley release · Drug: Triamcinolone
percutaneous A1 pulley release alone
Procedure: percutaneous A1 pulley release
Treatment trigger finger by release A1 pulley by percutaneous procedure
Triamcinolone 40mg/ml 1 ml injection concomitant percutaneous A1 pulley release
postoperative pain score
VAS(visual analog scale) from 0 to 10, 0 mean there is no pain, 10 there is the most pain in participants life
Time frame: post operative Day0 until 2 months
hand function by quickDASH
quickDASH(questionnaire in Thai version), score from 0-100, 0 mean there is no limitation of daily hand activity, 100 mean participants got disability in that upper limb
Time frame: post operative Day0 until 2 months
patients satisfaction
1 is lowest satisfaction, 5 is most satisfaction
Time frame: post operative Day0 until 2 months
Plan to share: Yes — Sharing the Dermographic data of the participants including age, BMI, Occupation and sharing of pain score, quality of life and satisfaction in result table
Supporting information: Study protocol, Sap, Csr
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Police General Hospital, Thailand